Immuno-Oncology Biotech in NJ

  • Our primary focus is targeted virotherapy, based on a fundamental mediator of cell immortalization in cancer 
  • Our goal: unlock the full potential of our virotherapy platform to treat a wide range of solid tumors, even immunologically cold tumor types

please email CV and cover letter to jobs@tseworldwide.com

Director, Clinical Development and Medical Affairs Strategy; NJ

Summary:

This position is responsible for the strategic clinical leadership for clinical development and medical affairs activities in support of the early and late-stage development portfolio in immuno-oncology. This role requires an individual with strong communication and leadership skills, as well as the ability to build strong relationships with key stakeholders (including overseas HQ) in R&D, Medical Affairs, Business Development and other relevant functions and navigate challenging situations. The individual must also be viewed as a strong scientific partner who can readily bridge between a cutting-edge research environment and a fast-paced clinical and product development organization. The successful candidate is expected to help drive effective pre-launch clinical development and medical affairs activities and to represent the department and programs at internal and external meetings. The individual should also have experience in regulatory affairs with CBER on immunotherapy.

Essential Functions

  • Provide exceptional scientific and regulatory expertise and collaboration within medical team, to your peers within the group, and to the organization in general.
  • Contribute to the formation, refinement and execution of medical strategies and tactics including early phase 1b/2 and late-stage 2/3 including Investigator-Initiated Study and/or company sponsored studies and ensure medical plans optimally are integrated into Lifecycle Management (LCM) through appropriate collaborations.
  • Establish and maintain relationships with KOLs, investigator sites, cooperative groups, professional societies in oncology, patient groups, and external consultants.
  • Ensure medical and product information is provided in compliance with relevant SOPs and that all data used in the provision of medical information are accurate and meet the needs of internal and external customers.
  • Contribute to the development of a strategic and robust Medical Advisory Board plan that aims to enhance product knowledge and to inform on clinical practice patterns and gaps.
  • Assist in the preparation publications of clinical study data and maintain a publication plan for our oncology portfolio.

Competencies:

  • Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
  • Excellent oral and written communications with ability to present data to all levels of audiences.
  • Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
  • Strong capability of strategic thinking and proposing innovative solutions to issues.
  • Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.

Required Education and Experience:

  • Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
  • Working knowledge of Clinical Drug Development.
  • Working knowledge of Regulatory requirements as pertained to biologics.
  • Working knowledge of Good Clinical Practice (GCP)
  • PhD degree preferred (Immunology or Oncology)

please email CV and cover letter to jobs@tseworldwide.com

Head of Clinical Development and Medical Affairs – NJ

Responsibilities:

Reporting to the leadership, Head of CDMA will be responsible for assisting in the implementation of our drug development strategy and will lead all aspects of individual drug programs. He or she will provide clinical input on clinical protocol development, regulatory issues and patient enrollment to clinical studies, safety monitoring and review, biomarker development, implementation and analysis of data, manuscript writing and submission, as well as presentation of data at national and international meetings. This position will have a strong outward facing presence and will support investigator-initiated trials and assist in the protocol review, site evaluation and selection process for clinical trials. The role functions internally as a medical expert/monitor to support the development and execution of an efficient and integrated global medical/scientific strategy including scientific evidence generation and scientific information exchange with key stakeholders.

The Head of CDMA is a Physican, preferably Board Certified. The ideal candidate will have history of clinical research or some industry experience in Oncology. The Medical Director is knowledgable of the actions of regulatory bodies, in particular the FDA, and has the experience in all aspects of clinical trials. The ideal candidate should have significant experience in their medical specialty and would thrive on proactively engaging internal and external leaders and will serve as a medical expert for their compound(s) and/or disease area. He or she will have strong commercial aptitude and/or experience, including proven ability to translate and appropriately align commercial and scientific goals and objectives. S/he will have solid peer relationships with external scientific and clinical experts in Oncology. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.

Key Accountabilities:

  • Help cultivate and advance a clinical development strategy and integrated development plan for the oncology program, design, biomarker and implementation of Phase I-III clinical studies in the immuno-oncology space.
  • Serve and Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators; CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trials.
  • Be responsible for analysis of clinical data, including safety monitoring in collaboration with the PV, and implement appropriate pharmacovigilance actions if necessary.
  • Provide medical insight into Advisory Board meetings, learning materials for internal and external use.
  • Assist in the development of publication plan for oncology products in development.
  • Complete scientific reports, manuscripts and other educational materials.
  • Work with investigators to identify publication and abstract opportunities.
  • Help to identify opportunities for data presentation and representation at national and international meeting and conferences.
  • Provide oversight for internal review of manuscripts and data presentations.
  • Contribute to business development efforts.
  • Participate, as requested, as clinical expert on due diligence teams related to external in-licensing opportunities.
  • Partner with business development team to evaluate novel targets and platforms in the immuno-oncology space.

Education requirements:

  • M.D. Required
  • Board certification, Board eligibility or specialist accreditation in medical oncology

Experience and skill requirement:

  • 2-5+ years of relevant clinical research experience in Oncology clinical development and/or medical affairs. Experience in the biopharmaceutical industry preferred; substantial experience working on industry-sponsored trials with immunotherapy will be considered.
  • Thorough understanding of Phase I-III drug development with proven ability to plan clinical trials, deliver high quality results within established timelines, interpret, analyze and communicate clinical/scientific data, and generate clinical/scientific documents.
  • A demonstrated track record of success in your field, the capacity to lead with minimal supervision, plan strategically, achieve goals on time, and communicate effectively.
  • Excellent written and verbal communication skills to meet the needs of varied audiences.
  • Strong interpersonal skills commensurate with the need to work closely with partners, investigators, contractors, consultants and team members across functions.
  • Knowledge of FDA/EMEA requirements, good clinical practices and pharmaceutical clinical development.
  • Closely interface with Clinical Ops and early development groups to define opportunities and explore new areas of scientific discovery.
  • Support R&D Management and the business development team with input on clinical development issues related to their BD plan, and support the business development process by providing medical expertise for in-or out-licensing, partnering and acquisition activities.
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs CTAs, investigator brochure, CRFs, annual IND reports, CSRs, ISSs, ISEs, and clinical export reports.
  • Lead and supervise clinical trials/registries, collaborating closely with the Clinical Operations team, and will be accountable for all deliverable of clinical trials under his/her direct responsibility.
  • Develop and maintain relationships and serve as the main medical liaison with KOLs and PIs.
  • Organize and present at relevant clinical advisory boards and or medical/scientific meetings as needed.
  • Develop and/or review clinical trial protocols and serve as the medical lead for trial conduct.
  • Assist in the review of investigator-initiated studies and in the identification of clinical sites.
  • Prepare and present documentation of clinical trial results to corporate committees, regulatory agencies and outside audiences, and publish results if research projects.

for consideration, please email cover and letter and CV to jobs@tseworldwide.com

Director, Clinical Development Operations; NJ

Position Summary:

  • This position is responsible for operational strategy, planning, implementation and management of our Immuno-Oncology clinical programs including company sponsored, Investigator-Sponsored Trials (ISTs) and Cooperative Group partnered trials. This includes overseeing the activities of all clinical trials from study design through close out including interpretation of clinical programs and the data collection activities; establishing and managing relationships with investigators, key opinion leaders, cooperative groups, vendors and stakeholders (CROs, central labs, IRBs, consultants) to facilitate clinical programs and ensure timelines and deliverables are met and that the studies are conducted in accordance with appropriate regulatory requirements. This role oversees the activities of all clinical trial partners including ISTs and proactively identifies, manages and communicates risks to key stakeholders, peers and senior management.

Primary Responsibilities:

  • Leads the operational strategy and tactics to develop, execute and deliver clinical studies/programs with a focus on speed, cost and quality.
  • Establishes and maintains relationships with key opinion leaders and investigator sites and consultants
  • Leads efforts for the selection and overnight of external service providers, including CRO and other vendors as necessary.
  • Independently manages the clinical study within the timelines and budget.
  • Identifies and manages ways to settle study issues that will impact budget, resources and timelines.
  • Recommends strategies for, and oversees, the execution of activities associated with clinical monitoring, safety, eligibility, enrollment and data consistency.
  • Ensures documentation prepared by CRO is completed in accordance with GCP regulatory requirements and consistent with the protocol of the clinical program.
  • Contributes to the creation and review of clinical components of key documents (e.g. investigator’s brochures, pharmacy brochures, clinical monitoring plans, Clinical Study Reports, DSUR, ) as needed.
  • Provides operational leadership for IND, NDA and/or BLA filing activities for assigned program(s) when applicable, including but not limited to: development and oversight cross-functional database lock activities within timeline; evaluation and if needed, escalation of resource needs both internally and externally with vendor partners.
  • Endure Trial Master File is accurate and up to date for inspection preparedness.
  • Lead and/or participate in process development and process improvement initiatives including development and authorship of SOP related to clinical trial conduct.

Qualifications:

  • Must have strong project and people leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner.
  • Excellent oral and written communications with ability to present data to all levels of audiences.
  • Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
  • Strong capability of strategic thinking and ability to propose innovative solutions to issues.
  • Advanced competence in collaboration & teamwork, communications, influence, strategic agility, planning & organizing, driving results and problem solving.
  • Minimum of 8 years of experience in clinical research working in a pharmaceutical, biotechnology or related environment.
  • Multi-study experience tuning Phase I, II or III clinical trials in Oncology
  • Working knowledge of, and experience with, clinical trial design, conduct, data acquisition and reporting.
  • Working knowledge of Good Clinical Practice (GCP) and Pharma Guidelines
  • PhD preferred (Immunology or Oncology)

please email CV and cover letter to jobs@tseworldwide.com

Senior Director of Legal and Intellectual Property

Biotechnology company dedicated to transforming the treatment of devastating diseases through the intracellular delivery of biologics. Our technology enables the efficient intracellular delivery of proteins, peptides and nucleic acids, thus allowing for the development of programs across several intracellular target classes. The Company’s novel approach addresses current challenges associated with both large and small molecule therapeutics and represents a fundamental advancement in the delivery of molecules into the cytosol.

Position Summary

We are hiring for a strategically-minded and detail-oriented Director of Legal and Intellectual Property with life sciences industry experience. This individual will be responsible for building and leading the Company’s intellectual property strategy by working collaboratively with both the research organization and the business functions. The successful hire will play a central role in shaping corporate strategy, act as a trusted legal advisor within the company and have a direct and significant impact on of multiple intracellular biologics programs. 

Job Responsibilities

  • Closely partner with the R&D organization to identify, develop and execute strategies to protect the Company’s intellectual property
  • Lead the drafting and prosecution of patent applications as in-house counsel to develop global, comprehensive intellectual property portfolios
  • Manage the existing patent portfolios and closely work with relevant collaborators
  • Provide patentability, freedom-to-operate and other legal opinions and risk assessments
  • Monitor competitive intellectual property, conduct prior art searches and respond to administrative challenges by third parties
  • Support business development and other contractual processes by drafting, negotiating and reviewing key legal and intellectual property-related aspects
  • Review publications, presentations, press releases and other materials for clearance
  • Effectively manage external relationships with outside counsel
  • Effectively inform and advise senior management on corporate legal issues

Qualifications

  • 5+ years of experience acting as patent counsel on biologics, either at a biotech or pharma company and/or representing such companies at a law firm
  • J.D. and admission in good standing to the state bar
  • Advanced degree in the biological sciences
  • Admission to practice before the U.S. Patent and Trademark Office (USPTO)
  • Strategic thinker who can anticipate legal and intellectual property-related issues and formulate and execute a course of action to address such issues
  • Excellent communicator with strong interpersonal skills who will act as a trusted partner for the R&D and G&A organizations
  • Significant experience drafting and negotiating agreements and contracts
  • Significant experience working collaboratively in a cross-functional team spanning scientific, clinical business and legal
  • Ability to manage and prioritize multiple workstreams simultaneously
  • Ability to work efficiently in fast-paced, changing environments and respond effectively in challenging and ambiguous situations

email resume and cover letter to jobs@tseworldwide.com

Multiple VP positions, NJ Biotech (coming soon)

We’ll be looking for up to 8 VP positions for a NJ Biotech with a top tier Board

Ideal candidates will for:

VP, Clinical Development

VP, Medical Affairs

VP, Commercial

VP, Managed Care-Market Access

VP, HR, Talent

Therapeutic and Disease category, Immune-Allergy and GI

candidates can feel free to reach out to tsharon@tseworldwide.com

President & CSO Rare Disease Platform

We have developed biological insights that suggest how specific enzyme loss leads to disease and potential strategies for replacing its activity. These discoveries also uncovered pathways where the enzyme intersects with cancer and other neurodegenerative diseases. We will leverage this knowledge to develop therapies for common and rare diseases. 

VP, Clinical Development, Oncology

The successful candidate will lead the clinical development of oncology therapeutics in pipeline. An ideal candidate is a physician scientist who is passionate about translating preclinical discoveries in oncology into next generation cancer treatments. He/she will clinical aspects of the biomarker program, interactions with oncology research to guide discovery programs, Additional responsibilities will include supporting and participating in developing the long-range strategic plans for oncology pipeline.

  • Leads clinical strategy for oncology pipeline.
  • Designs and executes clinical studies and research plans in support of first-in-human and Phase I/IItrials.
  • Contributes to selection of discovery compounds, design of development strategy and transition ofcompounds into early phase development.
  • Leads the interpretation of clinical results and makes appropriate recommendations in support of theoverall strategy.
  • Contributes to the writing and review of reports submitted to regulatory agencies.
  • Builds relationships with key opinion leaders and principal investigators.

• Contribute to corporate strategic and organizational initiatives. Knowledge, Skills and Experience

  • Strong leadership and communications skills are essential.
  • Ability to travel up to 15% of the time domestically and internationally.

Experience/Requirements:

M.D. or MD/PhD required. Board certification, or eligibility, in Oncology, Hematology/Oncology, or related specialty preferred.

Excellent scientific record with experience in basic cancer research and/or oncology clinical trials withinacademic institutions or the pharmaceutical industry.

More than 10 years of experience in clinical oncology and/or clinical development required; industry experience in immuno-oncology preferred and experience in intratumoral treatments is a plus.

  • Desire and ability to effectively participate within multi-disciplinary teams.
  • Strong leadership and communications skills are essential.
  • Ability to travel up to 15% of the time domestically and internationally.

Please email CV and cover letter to jobs@tseworldwide.com

Associate Director; M&A Analyst/Corporate Development

Summary

Corporate Development is a strategic function that encompasses strategy, portfolio management, and business development and licensing. This position will support us with evaluating business development and licensing opportunities and portfolio management-related initiatives. Working closely with the business development and licensing, commercial operations, Technical operations and R&D functions, the Senior Analyst will provide analysis and financial decision support to our various stakeholders.

The Senior Corporate Development Analyst will support the Corporate Development group in strategic investment and financial modeling and analysis, business planning, and presentation. This position will be responsible for developing forecasting analytics for various projects (in-licensing, acquisitions, pipeline assessments, process improvement) with respect to investment and return, capital budgets, and investment needs, as well as providing projected results and metrics in terms of return on investment, IRR, return on capital employed, and other relevant financial metrics.

Key Responsibilities

Prepare accurate and timely financial models and analyses in support of deals, portfolio projects, and investment opportunities under tight deadlines; create financial models incorporating research and analysis that shows leading indicators and key business projections and results.
Routinely support evaluation of business development, portfolio, and pipeline opportunities.
Help create presentations for senior management.
Manage multiple projects and competing priorities simultaneously
Develop and maintain relationships with various levels of personnel.
Engage with functional leaders to gather inputs.
Perform ad-hoc analysis and projects as required.
Assist as needed with building and maintaining dashboards and weekly/monthly reports for portfolio projects and deals under consideration.
Complete all company-based and job-related training as assigned by company within the required timeline.
Contribute to the best practices repository of the Corporate Development department.
Challenge processes and the status quo to drive improvements.

Job Requirements

BA/BS degree in Finance or equivalent. MBA and/or CPA certification preferred, not required.
Minimum years of experience: 5
Prior consulting, investment banking, corporate finance or related M&A experience-healthcare preferred.

Pharmaceutical Financial Modeling And Analysis Experience Essential.

Experience with risk adjustments as applied to investment decisions; discount rates, probability of technical and regulatory success, etc.
Demonstrate strong business acumen.
Technical expertise in finance, budgeting, and forecasting.
Knowledge of financial statement analysis and reporting.
Ability to build and maintain financial models.
Feel comfortable challenging business partners and make recommendations.
Critical thinking and problem solving skills.
Demonstrate strong attention to detail.
Must have excellent verbal communication and organizational skills.
Strong interpersonal skills including the ability to communicate effectively with individuals across all levels.
Ability to work in a fast paced, collaborative, team environment.
Commitment to quality and excellence, upholding the highest professional standards.
Effective presentation skills.
Advanced Microsoft Excel skills with the ability to provide meaningful analysis (toggles, project & deal scenarios).

qualified candidates should email resume and cover letter jobs@tseworldwide.com

Executive Director, Clinical Development

Position Summary
The Executive or Senior Director, Clinical Development  will provide medical input to Global Program Teams (GPTs), serve as medical expert for the study team and medical monitor for phase 1-4 clinical trials. The E/D is typically responsible for 1 or more medium sized clinical development programs under the supervision of the VP Clinical Development TA Head.  In addition, she/he may also have responsibility for discrete, specific business development efforts (e.g., a due diligence on a specific target). This position offers substantial opportunities for scientific and commercial interactions and career advancement in the fast-moving area of rare disease.

Job Duties & Responsibilities

 *   Medical input to the Global Development Team / Subteam
 *   Medical Expert for clinical study team
 *   Protocol development from concept to final protocol
 *   Protocol execution including interaction with investigators, and contributing to data review, data analysis and clinical study report authoring
 *   Scientific interpretation of data from clinical studies
 *   May supervise other medical monitors on individual studies
 *   Strategic guidance to phase I/II/III development programs and oversight of global clinical trials/trial team (s) on assigned programs
 *   Working as part of a cross-functional team with colleagues representing, for example, biostatistics, data management, clinical pharmacology, commercial, regulatory and project management
 *   Presentation at academic congresses, investigator meetings and advisory meetings
 *   Development of medical content for regulatory document, and responses (including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documents
 *   Providing medical/scientific input to evaluate potential business opportunities

Essential Qualifications

 *   MD or equivalent; Board Certification preferred
 *   5-10 years of clinical experience preferably within industry (minimum of 3 years of industry experience may be acceptable for outstanding candidates)
 *   Experience as a medical monitor for clinical trials required
 *   Regulatory experience preferred
 *   Publication in peer reviewed journals
 *   Excellent written / oral communication skills
 *   Attention to detail and ability to think strategically
 *   Willingness to take on new responsibilities
 *   Interest and ability to learn about new therapeutic areas
 *   Interest in career progression and ability to take on a more senior roles in 1-3 years

Preferred Qualifications

 *   Experience for medical responsibilities on a cross-functional team preferred
 *   Basic statistical knowledge preferred

please email CV and cover letter to jobs@tseworldwide.com

Sr. Vice President, Commercial


Every immune system has a story to tell— the key is knowing how to listen. Our goal is to meaningfully improve people’s lives by learning from the wisdom of their adaptive immune systems. It’s a bold objective that we’re uniquely built to achieve.

At Adaptive, you’ll be challenged, you’ll be inspired, and you’ll be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you’ll find a diverse, team-driven, fun culture where your contributions truly count. 

Position Overview

Adaptive aims to translate the genetics of the adaptive immune system to create clinical products to improve the way in which diseases are both diagnosed and treated. Specific to diagnostics, we have a robust clinical pipeline that leverages our partnership with Microsoft executed in 2017 to use machine learning to accelerate our ability to connect receptors and antigens at scale to enable our vision of creating a blood test, called immunoSEQ Dx, for the early and accurate detection of many diseases at the same time.  

Our path to commercialization starts with an initial focus on diseases for which there is a high unmet medical need and the antigens are well-understood. To begin with, we are focused on ovarian cancer in high-risk women as a test case for oncology, celiac disease as an example for autoimmune disorders, and lyme disease as a starting point for infectious diseases. We already have two early clinical signals from celiac and lyme disease. We expect to confirm at least one of these clinical signals and initiate a clinical validation study by the end of 2019, with a path towards submission to FDA for our first indication in 2020.  

At this stage, we are looking to build a commercial organization under this leader of immunoSEQ Dx to develop the markets for the initial selected indications as well as pave a path forward for the potential for immunoSEQ Dx to fulfill a novel paradigm of being “one test with many results.” We envision a future where this map will enable a doctor to get a clear picture of what a patient’s immune system is seeing from a single blood test, and we are seeking a bold, innovative, entrepreneurial, out of the box thinker to help us to make this vision a reality.  

The Senior Vice President, Diagnostics, immunoSEQ Dx is responsible for building and leading a team of colleagues, inclusive of Sales & Marketing and other key commercial functions, to launch immunoSEQ Dx in the initial indication(s) and to work with medical and regulatory to devise a path forward for a “one test with many results” medium to longer term product positioning.  

Specifically, this innovative and results-oriented leader will also design and implement a national reimbursement strategy for public and national/regional commercial payers, they will assess the market and develop an appropriate account-based brand strategy, they will lead the team that activates and develops accounts and that ultimately generates the pull-through revenues that will help Adaptive achieve and exceed its stated goals.  

The successful candidate will have a proven record of effectively collaborating with the payer community, establishing strategic contracts for innovative healthcare products and/or services, establishing clear objectives, aligning field resources with strategic opportunities, and developing incentive programs which drive teams to success. Hands-on leadership is essential to maintaining cross-functional collaboration and motivating the team to develop new programs and resources which will drive adoption of Adaptive’s diagnostic products.   

The SVP, immunoSEQ Dx, will sit on Adaptive’s executive leadership team and will report to the President.  


Responsibilities

  • Work with medical, regulatory, market access and commercial to formalize the go-to-market strategy for immunoSEQ Dx, inclusive of the initial indication set and preparing for the validation and roll out of the longer term product vision 
  • Integrate with and continue to develop the cross-functional alliance that has been built between Adaptive and Microsoft 
  • Ensure access to clinical samples and partners to expedite the creation of the antigen map 
  • In partnership with medical, institute key partnerships with integrated delivery networks, institutions, patient and payer organizations to develop and validate immunoSEQ Dx 
  • Develop network of key opinion leaders in each of the initial indications and more broadly with medical policy influencers to launch the product and grow it into “one test with many results” 
  • Provide commercial input to comp bio and software to guide data analyses 
  • Develop and implement payer strategies 
  • Develop the market, prepare for launch, and launch immunoSEQ Dx with top-notch team of sales professionals 
  • Lead and develop infrastructure to track, monitor and report on sales performance 
  • Collaborate closely across all functions to drive adoption and ensure effective customer management  

Requirements 

Skills, Abilities and Credentials 

  • At this stage, Adaptive is seeking a bold, innovative leader of teams who can productize one of the more promising data sets in history 
  • While familiarity with genomics and laboratory services will become necessary, we are open to meeting business leaders of varying backgrounds to identify the right leadership style and cultural fit  
  • Business travel is required for internal and external business meetings  

Qualifications 

  • Bachelor’s Degree is required, MBA or other related graduate-level degree is preferred  
  • Strategic understanding of how to forecast capability requirements, build future capabilities, optimize talent and drive development 
  • Experience identifying new customer and partnership opportunities, determining optimal relationship conditions/model (licensing, co-promotion, acquisition), and executing these relationships 
  • A demonstrated history of sales effective and leadership 

To learn more or submit your resume, contact us at jobs@tseworldwide.com

Head of Case Management Pharmacovigilance

Job Summary:
This position oversees case processing activities, staffing, processes, procedures, and interdepartmental projects involving PV case processing. This position collaborates within CSPV, interdepartmental teams, global teams, and interacts with CROs, vendors, partners, and study teams on all aspects related to case processing. This level oversees the PV role contributing to local and global aggregate reports. This level manages case processing issues, escalating to senior management, as needed. This level participates in hiring, compensation and personnel management decisions.

Responsibilities:

  • Case Processing: Oversees daily case processing staff assignments, activities, and projects. Interacts with vendors, CROs, and partners on a daily and as-needed basis. Escalates issues and develops resource strategy with senior management. Oversees CAPA implementation. Oversees metrics and management of staff administration including work schedules, rewards and discipline. Conducts mid-year and annual performance reviews of direct reports, contributes to compensation and hiring decisions.
  • Vendor Case Processing Oversight: Lead for PV CRO/vendor projects and ongoing management oversight. Monitors CRO/vendor reports (daily, weekly, monthly as required by project) to ensure quality completion of deliverables Responds to and manages escalated issues. Identifies and arranges for CRO/vendor training as needed. Works with Strategic Partner Management Lead to manage relationship with CROs and Vendors.
  • Case Processing Policies and Procedures: Reviews, approves, and provides input on SOPS, SOIs, process guides, PV Agreements. Participates in inspection preparation activities, internal / external audits and CAPA preparation.
  • PV Representative on Study Teams: PV contact for study teams as needed and oversees staff assignments on study teams. May attend multidisciplinary study team meetings and provide management oversight of initiatives and trouble shooting. Participates in Study Start up activities related to case processing as needed. Represents PV for review and comment on interdepartmental and CRO/vendor and partner projects.
  • Aggregate Reports: Participates in the preparation of routine and ad hoc Case Processing Compliance and Volume Reports. Oversees PV role in local and global aggregate reports and partner reporting requirements.
  • Case Processing Training: Reviews and approves case processing training materials.
  • Management Strategy and Goals: Develops PV goals, continued compliance and strategy for process improvement initiatives with senior management and PV management team.

Qualifications

Education and Experience

  • Bachelor’s degree in nursing, pharmacy, life sciences, health care or related field; 
  • Minimum of three (3) years of management experience in PV; 
  • Minimum of ten (10) years of Drug Safety/Pharmacovigilance experience, including both investigational and marketed products; 
  • Extensive knowledge of AE and drug coding conventions (MedDRA, WHO-DD). 
  • Extensive knowledge of FDA regulations, clinical and safety databases, 
  • Familiarity with Good Clinical Procedures (GCP) and Good Pharmacovigilance Procedures (GVP)

Competencies 

  • Ensures high quality work is completed throughout the function and that internal and external expectations and timelines are met. 
  • Develops functional strategic plans, provides guidance on priorities within the function and leads implementation.
  • Expertly identifies issues independently, thoroughly understands cause of issues, recognizes functional impact, develops and implements solutions.
  • Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the function.
  • Routinely interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
  • Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.
  • Applies clinical trial knowledge to influence strategy and promote efficiency and compliance for assigned projects within the team and externally.

Sr. Director, Clinical Safety – NJ

This position spearheads the development and implementation of global and integrated project/product risk management strategies, including developing processes/procedures to identify and evaluate safety signals for products

Job Summary

Position independently and effectively leads SMTs at any stage of development and is recognized as the product safety expert for assigned products at any stage of development. This position spearheads the development and implementation of global and integrated project/product risk management strategies, including developing processes/procedures to identify and evaluate safety signals for products. This position soundly and thoroughly integrates safety data from all sources to perform safety assessments, and to determine the safety profile of assigned products. In doing so, this position interacts with internal and external stakeholders to globally vet and communicate safety issues and serves on the TR-PT/IPT. Finally, this position reviews and approves safety documents and works on complex safety problems with minimal managerial review, such as the approach to safety assessment and regulatory response for a novel and serious safety signal. 

Responsibilities

Safety Expert – Overall: Serves as the physician responsible for determining the safety profile and for leading SMTs for assigned products from development through LCM. Defines the risk component of the B/R assessment. Is the primary author for the RMP. Maintains expert knowledge of regulations and guidance related to safety reporting and safety surveillance.

Safety Expert – Signal Identification: Creates signal identification methods for global products with minimal managerial input. Mentors, trains, and supervises junior staff involved in signal identification efforts.

Safety Expert – Signal Evaluation: Creates the approach to signal evaluation for global products with minimal managerial input. Supervises junior staff during signal evaluation efforts. Integrates and evaluates data to deliver comprehensive conclusions.

Safety Expert – Risk Mitigation & Communication: Is critically involved in creating, proposing and implementing risk mitigation actions for global products. Gains internal and external buy-in. Globally communicates product safety information to all internal stakeholders and works closely with Public Affairs to formulate communication for external stakeholders.

Reports and Submissions: Provides comprehensive and integrated reviews of safety sections in documents containing safety information. First authors white papers involving safety. Provides medical review for US and EU periodic reports. Is the primary owner of the RMP.

Qualifications

Education and Experience

  • Requires MD degree or equivalent
  • 5 years of relevant experience and board eligibility

to apply: please email resume and cover letter to jobs@tseworldwide.com

Global Sales and Marketing – Healthcare

Coming Soon…

Executive Level Sales and Marketing – Commercial Launch

For a preview discussion, please contact me tsharon@tseworldwide.com

Bay Area Biotech – COO or CBO

Bay Area Biotech seeded through 2021 with full Gene Therapy development team is seeking a COO or CBO

Ideal candidate has deep scientific background, preferably a PhD and has helped scale biotech business through early iterations. Alternative is successful strategy/management consultant with operating experience ready to take on this amazing leadership role.

For a full discussion, please email tsharon@tseworldwide.com

CSO/Head of Discovery AutoImmune Rare Disease

Head of R&D – Rare Disease,  San Francisco or Redwood Shores, CA

Job Description

The Chief Scientific Officer (CSO) will lead our research programs from hypotheses to clinical trials. The CSO will lead all preclinical activities (discovery, development, etc.)

Responsibilities

Preclinical

  • Evaluate current therapeutic avenues under investigation  and conceive of additional options to pursue, then contribute to program selection
  • Establish clear expectations and priorities and drive key initiatives to completion
  • Guide preclinical R&D for multiple programs
    • Plan research activities so they enable Investigational New Drug (IND) submission
    • Work with internal members and outside contractors to prepare research protocols
    • Analyze and interpret data, then advise on follow-up studies
  • Oversee preparation and submission of patent applications

Clinical

  • Lead IND through NDA (New Drug Application) submission processes
  • Interact with regulatory authorities and advisors to facilitate safe and rapid translation of preclinical research to clinical trials
  • Design clinical research study protocols, including objectives, patient inclusion/exclusion criteria, dose selection, endpoints, sample size, and safety monitoring
  • Interpret results from clinical trials and guide future trials
  • Maintain knowledge of treatment landscapes including current treatment strategies, current and potential competitors, and new therapeutic developments

Requirements

  • MD, PharmD or PhD in the life sciences with at least 10 years of pharmaceutical or biotechnology industry experience in clinical drug development
  • Comprehensive understanding of the drug development process in all phases of testing
  • Strong scientific background, exemplified by publications and overall stature in the pharmaceutical/biotechnology industry
  • History of leading teams from discovery to clinical stages
  • Extensive experience designing, running, and managing multiple pre-clinical programs simultaneously
  • Track record of successful IND submissions and experience interfacing with regulatory agencies
  • Significant experience in designing and carrying out clinical trials
  • Experience in drafting patent applications and moving them through to issuance
  • Ability to consider new information outside of his/her area of expertise
  • Excellent communication, organizational, and interpersonal skills

Not required, but desired

  • Experience in gene therapy, enzyme replacement therapy, or gene editing
  • Experience in developing treatments for rare diseases and/or neurodegeneration

Please email CV and Cover Letter to jobs@tseworldwide.com

Sr. Scientist-PK/PD

Boston, MA

Position Summary

We are seeking a highly motivated, collaborative, and innovative Senior Scientist, specializing in pharmacokinetics and pharmacology to join our protein therapeutics/biologics discovery efforts. The candidate will work with a world-class, multidisciplinary team of drug discovery scientists to lead the in vitro and in vivo ADME, PK, PD and toxicokinetic efforts to support biologics drug discovery and development. Specifically, the candidate will design, manage, and execute in vitro and in vivo programs both in-house and at contract research organizations. The candidate will also be responsible for analyzing, interpreting, and modeling DMPK and PK/PD data. The candidate will contribute to scientific publications and regulatory submissions as required.

Job Responsibilities

  • Design, conduct, and manage in vitro, and in vivo experiments to evaluate the ADME and PK profiles as well as toxicokinetics and immunogenicity of developmental biologics candidates both in-house and at contract research organizations
  • Develop and execute assays for measuring drug concentration, target engagement, and pharmacodynamic effects in vitro and in vivo
  • Champion innovation and new initiatives in discovery programs by proactively reviewing literature and other advancements in disease area biology
  • Interpret and present research data and findings in internal and external scientific meetings and conferences
  • Contribute effectively to patents, reports, and publications of scientific findingsE

Qualifications

  • Ph.D. in pharmaceutics, pharmacology, or a relevant scientific discipline and a minimum of 5-8 years’ experience in pharmacokinetics and pharmacology
  • Demonstrated knowledge of ADME, PK/PD, and bioanalytical development of protein therapeutics/biologics
  • Deep understanding of translational biology
  • Experience in bioanalytical techniques including assays for immunogenicity, in vitro and invivo toxicology, and histopathology preferred
  • Experience in assay development for target engagement and biomarker discovery preferred
  • Hands-on experience with LC-MS to analyze biological drug candidates preferred
  • Experience in contributing DMPK and pharmacology parts of regulatory submissionpreferred
  • Ability to collaborate with interdisciplinary team with excellent written and oralcommunication skills
  • Ability to multi-task to meet research and development goals
  • Drive to solve problems and ability to work independentlyCompensation is competitive and commensurate with experience. Competitive health, dental and vision coverage provided, as well as 401K and other benefits.To learn more or submit your resume, contact us at jobs@tseworldwide.com

Director, Program Management

SUMMARY OF POSITION

The Director, Program Management is the operational lead for a clinical stage program to ensure that program and corporate goals are met on time, within budget and with high-quality results.  Using solid program management knowledge and broad experience in drug development, the Associate Director, Program Management will partner with the relevant Medicines Lead to create development plans, but be directly responsible for the day-to-day, cross-functional execution of those plans.This role will support the Medicines Lead for Rare Disease.

MAJOR ACTIVITIES AND RESPONSIBILITIES

  • Supportive Leadership: Provides operational support and leadership and overall direction to cross-functional teams.
  • Planning, Documenting and Tracking: Facilitates achievement of strategic goals for a program by proactively planning tasks, documenting meeting outcomes including actions and decisions, and monitoring ongoing progress of deliverables.
  • Risk Identification, Mitigation and Communication: Scans workstreams to identify potential risks, develop mitigation plans and communicate these in a timely fashion to the cross-functional team and the Medicines Lead.
  • Budget Management:  Maintains spend levels in line with board-approved budget, supports contract request process from teams as needed.
  • Governance and Continuous Improvement: Ensures key recommendations flow through the Core Team, various Matrix Teams, and appropriate governance committees in the right order to ensure vertical and horizontal integration across functional areas and senior management. Identifies and analyzes problems, and recommends solutions to rest of Program Management as part of continuous improvement.
  • Communication: Ensures effective, accurate and timely communication of key issues and progress to the Medicines Lead, program team members, and other functions or governance committees as appropriate.
  • Other responsibilities may be assigned as required.

REQUIREMENTS

  • BS/MS in life sciences required; Advanced degree (PhD, MBA) preferred.
  • PMP certification preferred.
  • Minimum of 5 years of relevant program management experience in drug development managing clinical stage programs (Ph 1 – 3).  Other functional experience in drug development preferred (e.g. Clinical Operations, Regulatory Operations, Technical Operations, etc.).
  • Experience in marketing authorization submissions and approvals in Europe, U.S., Japan a plus.
  • Facility with tools and technology including MS Project/Powerpoint/Excel, SharePoint, teleconferencing platforms preferred.

EXPERIENCE AND SKILLS 

  • Excellent interpersonal, verbal and written communication skills.  
  • Able to work effectively in a cross-functional environment.
  • Detail-oriented and highly organized.
  • Works independently and under tight deadlines.
  • Comfort with ambiguity.
  • Able to resolve conflicts in a positive and collaborative manner.
  • Constantly looks for ways to improve (processes, own behaviors)
  • Able to manage up and down.
  • Self-awareness.

TRAVEL 

  • The role for may require up to 25% travel, both domestic and international.

Vice President, Process Development; Cellular Assays

Position Overview:

The Vice President (VP) of Product Development will be responsible for state-of-the art cellular immunology laboratory process and product development requirements. This key role will lead the transition of T-cell receptor (TCR) discovery workflows from research and proof-of-concept to the next product development stage. The VP of Product Development is accountable for implementing end-to-end TCR screening and characterization workflows, assay validations and standardization. S/he will implement GLP-compliant processes, production-level controls, drive assay / method validations, maintain all necessary documentation, and evaluate workflow changes that could affect the production and control of a TCR product. The VP of Development will put in place strategies to scale cellular immunology laboratory and support the development of IND-ready products.  This key leadership role will support corporate-level Drug Discovery goals.

Job Responsibilities:

  • Evaluate current cellular immunology and workflows, assays (e.g., TCR binding, cell killing and safety) and processes. 
  • Transition research-based workflows into product and process development under GLP conditions. 
  • Lead product development strategy and establish TCR product validation and development plans, including product characterization and safety evaluation. 
  • Maintain relevant requisite TCR screening and product controls plus validation data. 
  • Develop and maintain detailed reports containing TCR screening and characterization development methods. 
  • Lead efforts to inform the development of real-time, patient-specific TCR screening process for a future fully personalized TCR-based cellular therapy. 
  • Coordinate cross-functionally with R&D, Operations and leadership to provide timely product development needs that inform infrastructure or resource requirements.

Experience and Skills:

  • Advanced degree in Life Sciences: PhD, MD, or MD / PhD. 
  • Strong background and experience in biologics process validation and product development. 
  • Experience in cellular immunology / biology is preferred. 
  • >7 years of experience leading product development. 
  • Demonstrated understanding of assay and product development requirements. 
  • Ability to work in a matrix environment and leverage cross-functional resources. 
  • Ability to function autonomously and drive strategic decisions. 
  • Team leader with the ability to work and manage others. 
  • Ability to work effectively with senior-level stakeholders, internally and externally. 
  • Strong communication and interpersonal skills and good judgment. 
  • Independent strategic thinker with strong ability to solve complex problems. 
  • Excited about an early stage company environment and driven to make a difference.

Sr. Director/VP – Cell Therapy Discovery

Position Overview:

The Sr. Director of Cell Therapy Development will be responsible for establishing therapeutic product requirements and develop IND-enabling strategies for our Drug Discovery group. The Sr. Director of Cell Therapy Development will develop, plan and implement product requirements to inform clinical programs for T cell receptor based cell therapies plus any potential future drug modalities to be developed. S/he will establish product efficacy and safety specifications. In the near-term, this role will focus on informing robust TCR data packages for IND submissions and IND-enabling clinical trials.

This key role within R&D will guide the cellular therapy product development strategy and successfully enable us to achieve its Drug Discovery clinical development goals.

Job Responsibilities:

  • Lead IND-enabling strategy and establish TCR-based cellular therapy development plans. 
  • Inform clinical Target Product Profile (TPP) and develop IND-enabling TCR data packages. 
  • Support R&D efforts to ensure the creation of comprehensive product development plans. 
  • Support communications to fulfill regulatory authority requirements and address inquiries (e.g. Pre-IND meetings, IND questions and answers). 
  • Lead the development of product characterization; maintain relevant requisite product controls. 
  • Develop reports to support regulatory submissions/filings. 
  • Track and report any significant changes to the TCR discovery process / methods that may require amendments to regulatory materials or impact future manufacturing process and product development. 
  • Lead efforts to inform framework for real-time, patient-specific TCR screening, including immune monitoring during clinical trials. 
  • Provide timely product development requirements that inform new product/clinical needs. 
  • Write and implement development protocols, review and interpret data.

Experience and Skills:

  • Advanced degree in Life Sciences: PhD, MD, or MD PhD. 
  • Strong background and experience in biologics product development. 
  • Experience in cellular immunology/biology and cellular therapy product development. 
  • >5 years of experience leading biologics product development. 
  • Demonstrated understanding of IND-enabling product requirements and product launch. 
  • Ability to work in a matrix environment and leverage cross-functional resources. 
  • Ability to interact strategically with drug discovery partners to inform product requirements. 
  • Ability to function autonomously and drive strategic decisions. 
  • Team leader with the ability to work and manage others. 
  • Ability to work effectively with senior-level stakeholders, internally and externally. 
  • Strong communication and interpersonal skills and good judgment. 
  • Independent strategic thinker with strong ability to solve complex problems. 
  • Excited about an early stage company environment and driven to make a difference.

COO-CBO-CFO

I am working with select VC backed, post Series A biotechs on opportunities in Boston/Cambridge and the Bay Area. Opportunities for CBO, COO and CFO (or hybrid) and Investor Relations. Ideal backgrounds include M&A, Investment Banking, Equity Research and Sr Strategy Consulting. Please let me know If you are considering an operating role in 2020 and send message to tsharon@tseworldwide.com to set up a conversation

VP, CMC – Gene Therapy

Reporting to the Chief Portfolio Officer (CPO) and Head of Gene Therapy, the Vice President, Gene Therapy CMC will lead a team focused on CMC development of the gene therapy portfolio.  This individual will be a senior leader in the organization and contribute to the company’s research and development efforts to create high value gene therapies to address unmet medical needs for devastating rare diseases. The position will be based out of one of locations in the central NJ/Philadelphia area with laboratory facilities. 

This role is seen as a critical addition to the existing Tech Ops organization currently responsible for overseeing CMC product strategy development and execution of gene therapies, as well as overseeing the complex global network of partners who manufacture and supply clinical and commercial products.  

ROLES AND RESPONSIBILITIES

Primary responsibilities include:

  • Lead, define and build the broad gene therapy technical development and manufacturing strategy with members of the Technical Leadership Team, and  Gene Therapy Leadership Team 
  • Lead the multi-functional team responsible for the development and execution of comprehensive and integrated technical development plans for product portfolio
  • Coordinate and align with the Global Supply Chain leadership to implement the gene therapy supplier network strategy 
  • Direct the design, development, scale-up, and technology transfer of gene therapy manufacturing processes from feasibility test, pilot plant through manufacturing scale
  • Responsible for process development and provides support for process validation in accordance with regulatory guidance
  • Manage the development, implementation, and support of production processes, analytics, control methods and equipment to achieve stage appropriate production of preclinical test article, and early stage clinical trial material
  • Represents the Technical Operations function as a member of the cross-functional Gene Therapy Leadership Team (GTLT) providing strategic guidance to R&D Steering Team on the gene therapy programs and business
  • Work seamlessly with functional and cross functional stakeholders such as Research, Program Management, Alliance Management, Project Management, QC, QA, Regulatory, Manufacturing, Supply Chain and Manufacturing Science & Technology and external collaborators to help advance the portfolio programs through development
  • Key decision influencer on complex issues where analysis of situations and data requires an in-depth knowledge of process development and engineering, factors influencing scale up / scale down of critical process parameters and pharmaceutical production equipment
  • Has accountability for the technical, operational and financial performance of the Technical Development department
  • Is accountable for the alignment of the departmental activities with the activities of the peer departments
  • Provides overall direction to the function and is accountable for departmental deliverables
  • Works with the SVP, Tech Ops and the peer department heads to actively contribute to the gene therapy activities within Tech Ops
  • Coordinates with  the SVP, Tech Ops and the CPO & Head of Gene Therapy to develop and communicate strategic and tactical direction of CMC Development
  • Is recognized as a thought leader internally within and externally within peer communities and uses reputation to enable successful performance of the department
  • Select, develop, and evaluate personnel to ensure the efficient operation of the function
  • Represents the department internally/externally
  • Able to gather internal/external benchmarks for best practices in the scientific field
  • Other responsibilities/activities as may be assigned

ORGANIZATIONAL STRUCTURE

Dual reporting to the Senior Vice President, Technical Operations and CPO and Head of Gene Therapy

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

  • Ph.D. in engineering or life sciences

Professional Work Experience 

  • 5+ years direct leadership experience in gene therapy CMC development and manufacturing, bioprocess development or related areas
  • 10 – 15 years of experience of CMC development experience  
  • Experience managing a broad organization, as a leader of leaders
  • Experience with external manufacturing providers, partners, and/or academic collaborations is required
  • Demonstrated ability to successfully manage biologics/gene therapy  programs through technical development, including QbD process characterization and validation, is required
  • A keen ability and desire to grow an organization, mentor our next level leaders, and help manage the dynamics of change
  • Strong interpersonal skills with the ability to motivate others, influence, and negotiate conflict situations
  • Highly collaborative team player who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders
  • Ability to navigate and be successful in a fast-paced, highly-matrixed work environment
  • A passion for addressing the critical unmet medical needs of patients

To apply please email resume to jobs@tseworldwide.com

Chief Business Officer – Boston Biotech

Boston, MA

The Chief Business Officer, will provide leadership in the evaluation, development, implementation, and management of partnerships, collaborations, and/or acquisitions.  This key strategic role will lead a team of functional experts in science, clinical, program management, global marketing, legal and finance to evaluate opportunities, develop relationships with external parties, and ensure the corporate business development strategy is successful.    

 The individual in this role will be part of  our  Strategy and Business Development Group encompasses corporate strategy, business / corporate development and new product planning.  A critical component of the group is the Business Development function as the Company evaluates, plans and executes strategic business development opportunities including acquisitions, licensing agreements and partnerships.

To be fully successful at developing and implementing corporate strategy, this position requires a creative and analytical thinker who has previous experience with traditional corporate strategy initiatives.  In regards to Business Development, this position requires disease strategy, diligence, transaction and post-integration / alliance management experience.  This position offers the opportunity to help drive key decision-making activities within the Company.

Strategy:

Research, evaluate and recommend potential growth strategies through expansion into new therapeutic categories, markets and related businesses

 Lead analyses of pre-commercial and commercial opportunities (including epidemiology modeling and detailed revenue projections) related to corporate/business development initiatives

 Lead external innovation opportunities to expand commercial opportunity of both marketed and clinical programs

 Collaborate with Executive team and lead the development of a global strategic plan and collaborate with Finance team on the corporate long-range plan

 Collaborate with business partners on issue specific long-range strategic implications (for example, manufacturing strategy, pre-clinical target assessments, portfolio planning, etc.)

 Collaborate with internal stakeholders on identifying and incorporating innovative technologies 

 Work on CEO and Board-related strategy projects as needed

 Business Development

 Support in all business development activities and due diligence which includes valuation modeling, partner outreach, and managing technical and business due diligence processes

 Provide effective support on due diligence, transaction and post deal integration initiatives under the umbrella of business development

 Participate in the development of strategic partnerships, joint ventures and alliances, as well as platform technology and intellectual licensing opportunities

 QUALIFICATIONS AND BACKGROUND REQUIREMENTS

 Educational Requirements

 BS/BA required (MBA preferred)

 Professional Work Experience

 Minimum of 7 years of related experience in the biotech/pharmaceutical industry 

 Healthcare corporate strategy and transactional business development experience required

 Three plus years investment banking, strategic consulting, or related experience strongly preferred

 Deal / track record of successful identification, diligence and closing of opportunities 

 Rare disease experience strongly preferred

 Exceptional project management skills with ability to manage multiple projects in a cross-functional environment with good understanding of project management process

 Demonstrated competency in strategic thinking and leadership, with strong abilities in relationship management

 Demonstrated competency in conflict management, influence and negotiation skills

 Self-motivated, energetic individual who is dedicated to serving the needs of the rare and orphan disease community

 Strong customer focus with the ability to adapt to internal client needs and expectations

 Strong ability to influence outcomes without direct authority and ability to hold oneself and others accountable for commitments

 Highly organized and detail oriented with excellent follow-up abilities

 Strong familiarity with preclinical science, drug development and lifecyclmanagement of pharmaceuticals

 Ability to create and deliver effective presentations to working teams and senior management 

 Ability to create complex excel-based forecasts, NPV models and returns analyses

 Strong communicator and presenter, with the ability to persuade others and foster open communication across internal and external groups

***Interested candidates should email resume to jobs@tseworldwide.com for consideration

Director, Global Marketing, -Neuromuscular

Director, Global Marketing, -Neuromuscular (Location Open)

We are recruiting for the position of Director, Global Marketing, Neuromuscular who will be responsible for the development and execution of Global marketing strategies and tactics for our portfolio.

Reporting to the Therapeutic Area Lead, the Director will be in a critical position working cross functional teams, regional, country and corporate leadership and to advance care in the rare disease community and drive commercial success.

The Director, Global Marketing ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONSPrimary duties/responsibilities:

  • Assists in the development and execution of the Global strategic and tactical plan
  • Ensures strategic alignment between the Global strategic and tactical plan with the regions and countries
  • Develops the Global communication platform including key elements of positioning, messaging, value proposition, creative campaign, and promotional pieces
  • Creates and implements global educational initiatives (e.g. symposia, speaker’s bureau, stand-alone events) to raise disease awareness, increase patient identification, and drive belief in Translarna and Emflaza
  • Plans and executes HCP and patient market research and advisory board meetings to gain actionable market and customer insights
  • Works cross functionally to identify and partner with global KOLs
  • Understands the challenges and growth opportunities in the rare disease community and translating these into marketing initiatives
  • Plans and executes global congress activities
  • Manages external agencies to ensure execution of marketing programs aligned with brand strategy objectives
  • Ensures timely and efficient review of promotional materials and complying fully with all legal, regulatory, ethical, and company guidelines
  • Works with stakeholder partners in Medical Affairs, Marketing, Market Access, regional and country leadership, Distribution and Finance to optimize commercial success for the near term and future product launches
  • Leads a culture of compliance, integrity and transparency
  • Manages the operating budget(s) and initiating corrective measures as appropriate
  • Performs other tasks and assignments as needed and specified by management

KNOWLEDGE/SKILLS/ABILITIES REQUIREDMinimum level of education and years of relevant work experience.

  • 7 + years of experience in Global Marketing or other relevant functions
  • Launching and managing products globally in complex rare disease markets
  • Minimum of Bachelor’s Degree; Master in Science or MBA preferred

Special knowledge or skills needed and/or licenses or certificates required.

  • Demonstrated track record of success supporting the marketing and commercialization of an orphan, rare disease and/or specialized drug(s) that requires the development and execution of unique sales and marketing strategies.
  • Demonstrated success in developing and executing long term and annual marketing plans.
  • Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
  • Analytical thinker with strong problem-solving skills and the ability to adapt to changing priorities and deadlines. 
  • Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects. 
  • Ability to anticipate issues and respond quickly, flexibly and creatively to solve problems and address commercial market challenges
  • Hands-on experience in collaborating and working with patient organizations.
  • Ability to influence without direct authority.
  • Proficiency with Microsoft Office
  • Excellent verbal and written communication and skills.
  • Fluent in English (verbal and written).

to apply please send resume and cover letter to jobs@tseworldwide.com

Head of Developmental Sciences – San Diego

The Developmental Sciences Department is dedicated to strategies that bridge preclinical research and clinical development. Reporting to the CMO, this position will lead a team of scientists and/or physicians in defining and implementing translational initiatives. The incumbent will work cross-functionally to establish and implement research collaborations with other functional areas within the Company including clinical pharmacology, predictive biomarkers, pharmacodynamic biomarkers, and pharmacovigilance. This work will impact project level decision making and will require effective communications across a broad range of constituencies.

Key Responsibilities

  • Work with Team members and key partner functions (including Regulatory, Commercial, Nonclinical Development, etc.) to define biomarker strategies
  • Oversee the discovery and development of development and provide guidance to potential partners for co-development of companion diagnostics 
  • Collaborate with colleagues in research and other departments to advance internal research and early development projects 
  • Manage, mentor, advise and foster the career development of a diverse group of development sciences team professionals
  • Contribute to the Translational Medicine Team’s mission to understand the mechanism(s) of action 
  • Provide Translational Medicine support to partner functions; this may include providing input into clinical protocols, informed consents, sample collection manuals, investigator brochures and regulatory documents; helping to resolve biomarker-related questions from regulatory agencies; reviewing and interpreting clinical study outcomes, and overseeing the presentation of relevant results in clinical study reports and other study documents 
  • Maintain a strong understanding and awareness of emerging medical and diagnostic developments 
  • Develop models, both preclinical and clinical, to ensure robust decision making on developability of drug molecules in various therapeutic areas of interest
  • Design proof of concept studies and full development for various therapeutic area programs
  • Contribute to and review the clinical section of documents including, but not limited to, Protocols, the Investigator Brochure (IB), Case Report Forms (CRFs), Annual IND Safety Updates/EU Annual Reports, Clinical Study Reports, patient narratives, and submission related documents such as the Clinical Summary of Efficacy and Safety and the Clinical Overview

Education & Experience

  • A minimum of an M.D. or Ph.D. with at least 10 years drug development experience in a biopharmaceutical environment 
  • Demonstrated experience in development, implementation and execution of clinical development strategies for novel drug candidates, from preclinical development through clinical proof-of-concept 
  • Successful track record with biomarkers in the clinical space including development and implementation of biomarker strategies required 
  • Hands-on experience establishing clinical, molecular and cellular diagnostics 
  • Working knowledge of GCP and FDA regulations 
  • Advanced knowledge of immune-oncology and emerging therapies in oncology. 
  • Detail-oriented with the drive and ability to prioritize workload with limited supervision 
  • Strong interpersonal skills and the ability to function in a team environment 
  • Excellent written communication and oral presentation skills 
  • Phase 3 clinical development experience desired

to apply please send resume and cover letter to jobs@tseworldwide.com

Director, Program Management –NJ

Director, Program Management – Gene Therapy

Summary of Position

The Director, Program Management will support preclinical and/or clinical programs. The Director will be responsible for driving strategy and cross-functional execution on key program work streams, as well as for managing overall program timelines and budgets to support achievement of relevant corporate and program milestones. This role will contribute to the development plan and budget for the franchise.  In addition to these preclinical/clinical program responsibilities, the Director, Manager of Program Management will help support the Head of R&D Program Management with other initiatives as needed, and will contribute to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Roles and Responsibilities

  • Working closely with the Head of R&D Program Management and Discovery area leaders to manage development and execution of overall global strategy for the preclinical programs
  • Contributing to timely execution of program activities including anticipating and identifying project risks, mitigations and contingencies, and supporting timely action plans and issue resolution
  • Ensuring effective communication to align program activities with corporate strategy, and ensure effective program execution
  • Partnering with functional team members to monitor program spend against budget, and to develop project scenarios for decision making
  • Using key project management tools to enhance project and program delivery and information dissemination to the team and key stakeholders
  • Ensuring effective program team meetings, logistics and documentation
  • Contributing to development and review of corporate communications
  • Supporting other initiatives as needed
  • Contributing to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Qualifications and Background Requirements

  • A degree in the life sciences is desirable
  • An advanced degree in the life sciences, MBA or management consulting experience is desirable
  • Formal training in program/project management (e.g. PMP certification) is a plus
  • 6+ years of development experience in the pharmaceutical/biotech industry (with drug substance/drug product manufacture, preclinical, analytical, quality, clinical, and/or regulatory), of which 3+ years in program management
  • Strong interpersonal and communication skills for effective collaboration
  • Solid organizational skills including high attention to detail and ability to multi-task
  • Strong business acumen
  • Previous project management experience
  • In-depth experience with project management tools

Please email resume & cover letter to jobs@tseworldwide.com

Clinical Study Manager – NYC

Summary:

This position reports to the Director of Clinical Operations (or above). The right candidate will possess an understanding of Clinical Operations for successful execution of multiple clinical trials primarily in oncology and hematology indications in various phases of development.

Responsibilities:

Responsibilities of this position involve the day to day management and oversight of clinical trials in collaboration with a dynamic Clinical Development team.

Specific Responsibilities include:

  • Independent management of the operational aspects of our clinical trials, including vendors such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
  • Identification and qualification of clinical trial sites and investigators alongside CRO including management of key relationships.
  • Participation in final decisions for site selection with executive team.
  • Participation in the day to day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs
  • Management of clinical study budgets and execution timelines.
  • Leads internal team meetings for study management.
  • Facilitation of investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
  • Participation in the development of clinical trial protocols, amendments, CRFs, IRB/Ethics applications, and recruitment materials.
  • Attendance at site visits to ensure oversight of CRO monitors and effective collaboration with Investigators and site staff.
  • Review study reports and metrics to ensure timely collection of clinical data, samples, and lab results.
  • Collaboration on SOP development and promotion of standardized clinical business tools.
  • Development and review of specific study documents e.g. informed consent forms, study guidelines, operations manuals, training materials.
  • Development of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
  • Participation in the preparation of presentations of trial data for internal and external parties (management review, scientific meetings, and advisory boards).

Qualifications:

  • Minimum Education Required: Bachelor’s degree in a scientific discipline required. Advanced scientific degree is preferred.
  • The candidate should ideally have 4-6+ years in trial management with a sponsor company managing various phase clinical trials.
  • Experience in various phases of clinical trials and various therapeutic areas, including oncology, would be helpful.
  • Experience in CRO, vendor and laboratory oversight is required.
  • Motivated self-starter who is capable of flourishing in a fast-paced small company environment.
  • Creative problem solver with excellent communication and public speaking skills.
  • Strong interpersonal and organizational skills are needed, with a high degree of attention to detail. Ability to interact well with individuals at all team levels (e.g., Clinical scientist, Project leader, Physician, etc.).
  • Ability to travel for up to 30% of time, both domestic and international, may be needed.
  • Detailed knowledge of GCP and current US FDA regulations, and knowledge of other relevant global regulatory requirements a plus.

to apply for this position, please email resume to jobs@tseworldwide.com

VP or Senior/Director of Clinical Development – NYC

The Senior/Director of Clinical Development will report to the CMO and join our newly created development team in our new offices in Midtown Manhattan.  The successful candidate will be responsible for helping to develop our clinical trial strategy, design and execution from phase 1 to phase 3 for multiple assets in Solid and Hematological malignancies.  

Responsibilities:

  • Collaborate with Chief Medical Officer to provide leadership and medical/clinical input for our programs, protocols in development and clinical trial design
  • Serve as Medical Lead for multiple assets and prioritize trials
  • Lead Medical Monitor on trials for products in development in Solid and Hematological malignancies
  • Participate and work with team members to prepare and review regulatory documents and submissions (IND and NDA)
  • Identify and build relationships with KOLs and Clinical Investigators 

Qualifications

  • MD, DO or Equivalent 
  • Board Certification or Eligibility  in Hematology / Oncology strongly preferred
  • 3-5 years Clinical Development, Drug Development experience in Pharma or Biotech
  • Demonstrated expertise in Hematology/ Oncology Clinical Development
  • Excellent oral and written communication skills
  • Ability to demonstrate flexibility and handle lean environments 

to apply please send CV and cover letter to jobs@tseworldwide.com

Head of Clinical Development – NYC

The Head of Clinical Development will report to the CMO and join our newly created development team in our new offices in Midtown Manhattan.  The successful candidate will be responsible for helping to develop our clinical trial strategy, design and execution from phase 1 to phase 3 for multiple assets in Solid and Hematological malignancies.  

Responsibilities:

  • Collaborate with Chief Medical Officer to provide leadership and medical/clinical input for our programs, protocols in development and clinical trial design
  • Serve as Medical Lead for multiple assets and prioritize trials
  • Lead Medical Monitor on trials for products in development in Solid and Hematological malignancies
  • Participate and work with team members to prepare and review regulatory documents and submissions (IND and NDA)
  • Identify and build relationships with KOLs and Clinical Investigators 

Qualifications

  • MD, DO or Equivalent 
  • Board Certification or Eligibility  in Hematology / Oncology strongly preferred
  • Minimum 7 years Clinical Development, Drug Development experience in Pharma or Biotech
  • Demonstrated expertise in Hematology/ Oncology Clinical Development
  • Excellent oral and written communication skills
  • Ability to demonstrate flexibility and handle lean environments 

to apply please email CV and cover letter to jobs@tseworldwide.com

Associate Director, Program Management – Gene Therapy

Associate Director, Program Management – Gene Therapy

Summary of Position

The Associate Director, Program Management will support preclinical and/or clinical programs. The Associate Director will be responsible for driving strategy and cross-functional execution on key program work streams, as well as for managing overall program timelines and budgets to support achievement of relevant corporate and program milestones. This role will contribute to the development plan and budget for the franchise.  In addition to these preclinical/clinical program responsibilities, the Associate Director, Manager of Program Management will help support the Head of R&D Program Management with other initiatives as needed, and will contribute to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Roles and Responsibilities

  • Working closely with the Head of R&D Program Management and Discovery area leaders to manage development and execution of overall global strategy for the preclinical programs
  • Contributing to timely execution of program activities including anticipating and identifying project risks, mitigations and contingencies, and supporting timely action plans and issue resolution
  • Ensuring effective communication to align program activities with corporate strategy, and ensure effective program execution
  • Partnering with functional team members to monitor program spend against budget, and to develop project scenarios for decision making
  • Using key project management tools to enhance project and program delivery and information dissemination to the team and key stakeholders
  • Ensuring effective program team meetings, logistics and documentation
  • Contributing to development and review of corporate communications
  • Supporting other initiatives as needed
  • Contributing to strategic projects across the R&D program portfolio such as portfolio planning, due diligence, and long-term planning.

Qualifications and Background Requirements

  • A degree in the life sciences is desirable
  • An advanced degree in the life sciences, MBA or management consulting experience is desirable
  • Formal training in program/project management (e.g. PMP certification) is a plus
  • 6+ years of development experience in the pharmaceutical/biotech industry (with drug substance/drug product manufacture, preclinical, analytical, quality, clinical, and/or regulatory), of which 3+ years in program management
  • Strong interpersonal and communication skills for effective collaboration
  • Solid organizational skills including high attention to detail and ability to multi-task
  • Strong business acumen
  • Previous project management experience
  • In-depth experience with project management tools

Please email resume & cover letter to jobs@tseworldwide.com

Exec Dir/Sr/Director, Oncology Clinical Development

NYC based Biotech with innovative chemistry program to develop novel, best in class therapeutics to fight solid and hematological malignancies

MD degree or foreign equivalent with board
certification/specialization in Hematology and/or Oncology preferred

Experience managing oncology trials

At least 3 years (more for senior title) of relevant drug development
experience, either within industry or as a clinical investigator/physician
scientist in academia, or equivalent experience

Proven clinical development strategist with experience designing,
implementing and conducting clinical trials

Knowledge of carrying out hematology/oncology clinical trials, including knowledge of hematology/oncology treatment options

Ability and desire to work in lean, fast-paced biotech with a flat structure



Director, Clin Ops, NYC Biotech

Innovative clinical-stage biotech with multiple assets and a unique platform is looking for a Director of Clinical Operations to provide strategic vision and direction as the business grows. As a leader in the company, you will be responsible for growing the team, and setting the standards for the strategy and processes required for successful life cycle management across the therapeutic portfolio.

Armed with an incredibly strong pipeline, we are now looking for a new Director, Clinical Operations to drive the team forward in this period of growth.

Responsibilities and Job Duties

  • Defining the Clinical Operations strategy, clinical trial execution, timelines, resource planning, budget forecasting and study management
  • Managing a Clinical Operations team focused on all aspects of clinical trial management including administrative, budgetary, resource, and performance management responsibilities
  • Providing leadership within the Clinical Operations department, acting as a point of escalation and supports cross-functional issue resolution, as required
  • Leading cross-functional teams whose mission is to deliver high quality and timely execution of clinical development plans including the setup, conduct and reporting of clinical trials
  • Provides strategic, tactical and operational input to Product Development Teams to ensure appropriate planning and to drive better decision making
  • Partnering with Clinical Operations Outsourcing team to oversee and coordinate all budgetary activities for assigned programs including project budget creation, forecasting, accruals reporting and invoice approval and to oversee and coordinate all budget-related activities for vendors and clinical trial sites.
  • Engaging key stakeholders to ensure expectations their expectations of clinical operations are being met or exceeded and responds. Addresses concerns proactively, makes recommendations where necessary and brings to resolution
  • Ensuring that clinical operations processes, systems and tools are standardized and being utilized, and adequately meet the needs of staff and stakeholders
  • Maintaining awareness of overall developments and benchmarks in Clinical Operations and shares best practices with leadership team to drive change and improvement
  • Collaborating with Human Resources to identify talent, recruit, train and develop, and retain team members to provide the highest level of performance and accountability.

Qualifications

  • Bachelor’s degree, preferably in health care, life sciences, or related discipline
  • A minimum of 10 years of experience within a clinical operations team in the Biotech/Pharmaceutical industry
  • A minimum of 5 years of successful experience managing people and vendors
  • Several years of experience managing Phase I, II and Phase III clinical studies in immune-oncology
  • Thorough understanding of the processes associated with executing a clinical development program including: clinical trial design, implementation, management and reporting
  • Advanced leadership, project management, resource management, administrative and technical capabilities
  • Advanced knowledge of Oncology clinical trial design, implementation and management
  • Understanding of Oncology therapies and practice as it relates to clinical trial design

Want to apply or find out more? Email jobs@tseworldwide.com

Executive Director, Rare Disease Product Development

Executive Director, Product Development, Bay Area

Product Development is responsible for corporate and R&D governance, business operating model (core teams and sub-teams) and portfolio strategy. Product Development integrates overall product strategy and ensures planning and timely execution to inform decision making and development of therapies .

Role:

Product champion and leads a team of core functional leaders that together help develop product strategy and planning for clinical and/or marketed products. You will be the primary liaison between team/sub-teams and executive management and has overall accountability to executive management (CEO and CEO leadership team) for the integrated product strategy. In collaboration with core team (CT) members, ensures progress and execution against plans and as the leader of the CT is the primary contact for internal stakeholders. As a senior leader in the core team leader group, is a role model, mentors peers and contributes to key core team processes and initiatives.

Key Responsibilities:

Program Strategy
Lead the CT in the generation of a Target Product Profile and the cross-functional compound development and lifecycle strategy taking into account global considerations
Lead CT and develop forward looking integrated stage based product development plans that are aligned with program strategy and ensures assumptions and drivers are aligned with plans to inform financial planning
Lead efforts in partnership with line functions to optimize value of the compound throughout its lifecycle.
Ensure potential risks are identified and contingency planning with a solutions focused mindset.
Team Effectiveness
Ensure cross functional partnerships and resources are leveraged effectively, and with accountability, to achieve program objectives.
Drive collaboration and transparency across all functions on the CT and challenge team members to be broad and inclusive in their strategy planning.  
Resolve conflicts at the Core Team, provide and receive feedback to develop and maintain a high performing team and if necessary escalate team member performance related issues to functional management
Governance and Approvals
Ensure that team recommendations are brought to appropriate governance for management buy-in and decisions
Ensure alignment of program strategy/plan/execution with management expectations & priorities
Lead CT in the development of scenarios and recommendations and present CT position for decision making at various governance bodies. Leverage SMEs for expertise and have SMEs present on topics pertaining to their areas
Communication
Single point of contact on program for executive and functional management
Ensures communication of rationale and context for decisions made to team
Leads team in developing a comprehensive internal and external communication plan with team input for important program milestones, key data, etc.
Reviews and agrees to publication plan, reviews publication concepts, presentations and manuscripts
Primary source for information as needed for external communications (press releases, investor related, etc.)
Reviews health authority related documents and ensures consistency with strategic objectives for the program
In partnership with Project Management Lead, CTL ensures
Timely progress and execution against strategy and plans
Timely and aligned input into drivers for LRP and Budget process
Requirements

Education:

The successful candidate will ideally have an advanced degree in a scientific discipline (e.g., Ph.D. or M.D.); M.B.A. is a plus.

Experience:

15+ years (Executive Director) or 12+ years (Senior Director) experience in the biotechnology/ pharmaceutical industry. Ideally, the individual will have experience in drug development across several therapeutic areas and across the spectrum of drug development and life cycle management.
Experience as a leader of product or compound strategy teams or sub-teams. Experience leading a core/cross functional strategy team for an investigational therapy through development is preferred.
The successful candidate will also demonstrate strong leadership ability and professional credibility to influence a highly intelligent and sophisticated audience of colleagues, partners, and external constituents.
This individual must be a self-starter and possess excellent leadership, influencing and communication skills, as they will be applied at all levels, including at the core team, interactions with the executive team, and presentations to high-level internal and external audiences

Head of Regulatory – Gene Therapy -NJ/Boston/San Francisco

RESPONSIBILITIES:

Reporting to the Chief Development Officer the successful candidate will:

  • Act as the regulatory lead on specific program(s) and represent the regulatory function on related cross-functional program teams
  • Participate in definition and implement regulatory strategy for path to approval
  • Plan, prepare, and review submissions to regulatory authorities (including FDA, EMA and other national authorities) to support the conduct of clinical trials and approval of marketing applications (IND, CTA, BLA, MAA)
  • Lead regulatory activities for assigned projects in line with US, European, ICH, and other applicable requirements to ensure compliance
  • Manage the regulatory aspects of products and projects including achievement of timelines and deliverables
  • Ensure that regulatory documents are accurate, complete and verifiable, and confirm compliance with regulatory requirements
  • Be the primary liaison with regulatory authorities for the specific programs he/she is leading
  • Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities
  • Coordinate and prepare responses to questions, requests for information from regulatory authorities
  • Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs
  • Train and mentor other regulatory affairs personnel
  • Other activities as may be assigned

To apply please email resume and cover letter jobs@tseworldwide.com

SVP Business Development and Operations

SVP Business Development and Operations – Bay Area

Description The incumbent develops and executes strategies to identify, assess, and pursue new business opportunities that significantly enhance the value of the Rare Disease and Oncology business. Translates unmet customer and market needs to unique and innovative new business opportunities. Directs the development of business cases for new opportunities, including ensuring that all ideas and opportunities are prioritized, vetted and validated. Partners with CEO to gain approval and buy in for new business opportunities and alliances. Responsible for coordinating due diligence efforts, developing negotiation strategy, and leading negotiation discussions. Execute contracts, closes deals, and develops integration plans. Other Responsibilities include: Strategy – Market / Product / Technology Assessment and Prioritization Work to develop Business Development strategy which supports strategic plan of the business Identify, evaluate, and recommend business development opportunities to CEO and Board by building a strong business case and rationale Create and maintain a proper size of pipeline deal opportunities with management alignment on their priorities Remain abreast of market trends, dynamics and engages the organization to continually stay ahead of competition Leadership: Lead and coordinate due diligence process, work with core team and extended team members from different functions, markets, and region and corporate Oversee the financial modeling process for opportunities including development of P&L’s , CNDP, NPV’s and IRR’s Manage internal deal teams to meet partner deadlines, to insure appropriate input from all functional groups, including corporate functions (tax, treasury, M&A finance, insurance, quality, supply chain, regulatory, human resources, environmental, corporate affair, investor relations, legal etc) Develop deal structure and negotiation strategy Lead the process for obtaining management approval to execute negotiated contracts Establishes clear expectations, sets priorities, focuses resources, delegates effectively, and continuously communicates progress to senior management. External Relationship Management Build and maintain industry contacts with key Business Development executives Leverage existing key contacts to generate leads and continuously foster new opportunities Represent to prospective external partners Deal Negotiations: Simplify complex situations, make sound judgments, and be accountable for outcomes. Interact and influence all levels within the organization; high level of collaboration and influencing skills. Develop and negotiate term sheets and contracts with external partners Lead negotiation process to achieve key business objectives and terms Other: Coach, develop and assess subordinates utilizing key HR processes to include Performance Management and Succession Planning. Focuses on developing individuals as well as building a high performance team Qualifications A minimum of a bachelor’s degree is required with an advanced degree strongly preferred. A minimum of 12 years business experience with at least 5 of those years in M&A is required. Broad and deep business acumen, adept with complexity, superior analytical skills is also required. Experience working in a decentralized and global enterprise-wide business model successfully is highly preferred. Demonstrated ability to influence at various levels (internally and externally) – Project Team management experience – Experience in managing multiple projects simultaneously is required. Visionary leadership, preferably demonstrated in different business environments and models is also required. Experience developing strong, diverse teams and differentiates performance and delivering feedback effectively is a must. The candidate must also display use of different leadership styles (collaborative, authoritative, coaching, etc.) and uses these styles appropriately to build the necessary bridges and get things done is needed. Must be viewed as an experienced, objective, executive, who provides recommendations in a transparent and balanced manner.

please send resume to jobs@tseworldwide.com

Director, Worldwide Commercial Strategy

Location: NJ

Description

The Director, Worldwide Commercial Strategy is responsible for ensuring the delivery of critical short- and mid-term strategic initiatives for the Commercial organization. The position plays a central role in the delivery of Commercial business priorities, the evolution of the Commercial organization and capabilities, and the effectiveness of interfaces with key functions (eg, R&D, GPS, BI&A Enabling Functions). This role will require strong partnership with the Commercial Leadership Team (CLT).

Key Responsibilities

  • Leads critical strategic initiatives for the Commercial organization
  • Support the evolution of interface between key functions in Commercial and between Commercial and other functions (e.g., R&D)
  • Drive preparation for key senior management reviews and presentations
  • Interface with the various Leadership Teams and across the matrix to ensure appropriate understanding of all key initiatives and organizational priorities.

Qualifications:

  • 8-10 years combined experience in Marketing, Sales, Access, Medical and Ops
  • Strong problem solving and analytical skills: effectively structures business problems; leverages data (qualitative and quantitative) to identify insights and inform recommendations; leverages key matrix partners (i.e., BI&A)
  • Focus on execution and value delivery: strong track record of execution/ implementation across matrix teams; simplifies unnecessary complexity to get to action and value
  • Excellent written and oral communication skills – especially executive level communications
  • Demonstrates success in driving optimal business objectives in a complex matrix organization required
  • Ability to work on multiple major strategic initiatives and influence senior executives
  • In-depth experience in US, other key markets and/or WW Commercial strongly preferred
  • Ability to prioritize work with autonomy and drive results under pressure
  • BA/BS required. MBA, PharmD, or other graduate experience strongly preferred

Chief Medical Officer – Oncology; CT

Chief Medical Officer will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

The Chief Medical Officer will report to the Chief Executive Officer and will be part of the Executive Leadership team.

Additional responsibilities required include:

  • Drive strategy and execution of clinical and regulatory development activities from pre-IND through clinical development
  • Directly supervise clinical operations, clinical research, data management and analysis, regulatory and medical affairs, and support related hiring strategy and decisions
  • Supervise development of patient registry and / or natural history studies 
  • Manage the analysis, interpretation and reporting of clinical trial data and results 
  • Work with internal and external parties to develop target product profiles and translate these product profiles into clinical development
  • Provide strategic input supporting prioritization of preclinical programs, in collaboration with Chief Science Officer
  • Collaborate with Chief Science Officer to move discovery / preclinical product candidates into clinical investigations / development
  • Help establish Company culture in a manner consistent with the company’s values
  • Communicate on behalf of the Company with key opinion leaders and patient communities at conferences and other external events, and also with investors, in a manner supportive of the Company’s objectives
  • Represent the Company with regulatory and legislative agencies 
  • Develop and manage clinical and regulatory budget

Qualifications

Education and Experience: 

  • MD / PhD 
  • Minimum of 10 years relevant experience in all aspects of designing and executing clinical trials, including early clinical / translational development and mid to late stage clinical development and execution 
  • Experience in managing clinical operations, regulatory affairs and medical affairs groups

Knowledge and abilities:

  • Expert knowledge of rare disease clinical trial design and analysis
  • Deep scientific, technical, and regulatory understanding of drug development
  • Budget management and project management experience
  • Team player with executive demeanor, strong judgement, and decision-making capabilities
  • Outstanding management, interpersonal, communication, negotiation, and problem-solving skills
  • Highly motivated individual who can accommodate the demands of a rapidly growing biotechnology company

Additional information

  • Position is located in Boston, Massachusetts and will require up to 25% travel 

Applicants should send CV and cover letter to jobs@tseworldwide.com

VP; Pharmacovigilance

The VP Pharmacovigilance will build and lead the Pharmacovigilance group, provide hands-on medical monitoring, and strategic leadership for assigned investigational and marketed products. This individual will oversee the operational infrastructure required to oversee all aspects of adverse event collection, processing and reporting from clinical trials, post marketing and other sources, as applicable. This critical role provides strategic guidance to other functions (such as Data Management, Biometrics, Clinical Operations, Clinical Development) involved in adverse event collection and safety management throughout the lifecycle of therapies. The role will be based in the Bay Areaand will report directly to the Chief Medical Officer. 
Key Responsibilities

  • Leads and directs all aspects of pharmacovigilance activities for assigned investigational and marketed products 
  • Responsible for developing, executing and maintaining risk management strategy for assigned products 
  • Authors, reviews and provides input for drug-safety related regulatory reports and clinical study documents including periodic aggregate reports, case series analyses, regulatory submission documents 
  • Contributes to the development of internal processes including SOPs, Guidelines and Work Instructions 
  • Acts as medical and scientific subject matter expert for the pharmacovigilance capabilities build of a growing function within the Company 
  • Leads the labeling activities for the safety sections of the assigned product/indication 
  • Leads the creation of responses to safety questions from Regulatory Agencies for the assigned products/projects, and reviews and/or contributes to responses for safety questions for non-assigned products/projects 
  • Contributes to the Safety Medical Teams for meetings associated with assigned products/indications 
  • Designated Subject Matter Expert for medical questions related to processing ICSRs in partner audits and regulatory inspections 

Knowledge, Skills and Experience

  • MD (or equivalent) 
  • Minimum 15 years of experience in medical drug safety in the pharmaceutical industry and demonstrated results in managing the multiple facets of clinical safety and pharmacovigilance 
  • Substantial knowledge and experience with drug safety medical assessments in clinical trials and post market 
  • Experience in developing risk management strategies and writing risk management plans 
  • Experience and extensive working knowledge with Drug Safety Databases, data analysis tools, and document management systems 
  • Understanding of how global drug safety related regulations are applied 
  • Experience in leading cross functional drug safety team and cross-departmental interactions with clinical development, medical affairs, regulatory affairs, and commercial groups 
  • Excellent knowledge of drug development process 
  • Strong leadership and oral/written communication skills 
  • Ability to travel up to 20% of the time domestically and internationally 

Want to apply? Please send your resume to Michael Tal Sharon

jobs@tseworldwide.com

Gene Therapy – Leadership Opportunities

TSE is pleased to announce a partnership with several early stage (pre-IPO) but well funded companies in the AAV Gene Therapy space in Boston and Cambridge, MA, NYC, Philadelphia and San Francisco

Open positions will be created and posted soon but will include:

  • CSO
  • S/VP Head of Translational Biology
  • CMO
  • Head of Clinical Development
  • Director, Clinical Operations and Program Management

We’re very excited to be able to collaborate with these companies working to advance potential life saving treatments across many Rare Diseases

Please stay tuned for updates here and on LinkedIn

Feel free to email me as well Email

 

 

Successful Oncology Placements

We have been fortunate to work closely with a global biopharma to help build their commercial strategy team.  We are fortunate to work with companies making a meaningful difference in the fight to end cancer.  This company is building their global strategy as they move Immuno-Oncology therapies to market.

Contact us jobs@tseworldwide.com to help build your team!

Successful placements with global pharmaceutical company

  • Director, Clinical Development – Immunotherapies

https://wp-k1hwq7y3c2.pairsite.com/director-clinical-development-immunotherapies/

  • Director; Worldwide Oncology Commercial Strategy           

https://wp-k1hwq7y3c2.pairsite.com/director-worldwide-oncology-commercial-strategy/

  • Director; Business Development & Clinical Collaborations             

https://wp-k1hwq7y3c2.pairsite.com/director-business-development-clinical-collaborations-oncology-commercialization/

  • Director; Worldwide Strategic Analytics and Budgeting

https://wp-k1hwq7y3c2.pairsite.com/director-io-analytics/

A/D Strategic Planning – Bay Area

The Strategic Planning & Project Management Group’s (SPPM) primary objective is to achieve and maintain sustainable growth by maximizing value and prioritizing resources across the portfolio. The Associate Director, Strategic Planning will play a critical role in driving success by contributing to this objective. He/she will be integral to executing on algorithm and approach to balancing opportunity and risk across therapeutic areas, including building and assessing business cases (e.g., new indications, new geographies) within the portfolio. This person will be in a key position to “connect the dots” across groups, functions, and therapeutic areas to optimize strategic decisions and execution. He/she will interface often with the Senior Management Team and is expected to communicate in a clear and data-driven manner, from written communication to live presentations. This person will be based in Palo Alto and report to the VP, Strategic Planning & Project Management group.

Key Responsibilities

• Collaborate across functions to develop business cases (e.g., new indications, new molecules, new geographies) for new opportunities

o Evaluatebusinesscaseswithinportfoliocontexttoprioritizeandre-prioritizeopportunities across the company

o Ensure company resources (people, investment, time, energy) are aligned with prioritized opportunities

  • Collaborate with Groups within the Senior Management Team (e.g., Endocrinology Rare Disease Group) to strengthen cross-company view, decision-making processes, and communication; set agendas, as well as communicate decisions, action items, and minutes to Groups’ relevant stakeholders
  • Develop agendas and materials, and drive execution for key internal and external milestone meetings (e.g., board materials, Corporate Monthly Reports)
  • Monitor, analyze, and disseminate competitive intelligence (including press releases, SEC filings, company websites, conference communications)
  • Stay current on key publications (e.g., scientific literature, analyst reports, regulatory landscape changes) and share findings with key stakeholders
  • Engage with and support Project Directors in their efforts to drive projects’ strategic decisions, timelines, and budgets
  • Support business development efforts to bolster sustainable growth across therapeutic areas, including new technologies, licensing partners, geographic partners
  • Lead special projects
  • Lead/contribute to operational initiatives, as needed – examples could include:

o Scenario planning and forecasting use of drug supply
o Acting as point of contact for external partners (licensing partners) o Contributingtobrandnaming

• Establish processes, structures, and templates to support growth (e.g., business case templates, out-of-budget requests, subscriptions tracker)

Knowledge, Skills and Experience

  • Bachelor’s degree required, preferably in Life Sciences
  • MBA or advanced degree in Life Sciences (or related field) preferred
  • At least three years relevant experience
  •  Experience in biotech/pharma, i.e., pharmaceutical R&D drug development knowledge and familiarity with key biotech/pharma functions and processes, strongly preferred
  •  Excellent analytical skills and ability to provide strategic insight and problem solve, quantifying options, tradeoffs, budget, and resources needed – Top-tier consulting and/or investment banking background strongly preferred
  • Exceptional interpersonal skills (including cultural sensitivity) and communication skills (including presentations, written communications)
  • Strong leadership skills, including ability to lead colleagues across line organizations outside of reporting relationships
  • Driven by curiosity and strong interest in learning; willing to “dig into the science”; dedicated to becoming an expert on the therapeutic areas, technology, products, competitors, and related areas
  • High level of organizational skills and attention to detail
  • Role model of the company vision, mission, and values
  • Ability to travel up to 20% of the time domestically and internationally

For consideration, email resume and cover letter to jobs@tseworldwide.com

Recruiters -any location

We are looking for recruiters of any level to come work with us.

Please visit our careers page https://wp-k1hwq7y3c2.pairsite.com/category/careers/ to see the positions we typically support for our clients.

Send resume and cover letter to jobs@tseworldwide.com

CNS Research Scientist I / II

This position is part of our CNS gene therapy team and involves contributing experience and knowledge to the design and analysis of animal studies using AAV vectors. This includes the development of strategies to test these reagents both in vitro (e.g. primary human cells and iPSCs) and in vivo (mammalian model systems). The position further requires remote management of CROs, site visits, and hands-on analysis of study samples. The position also supports the development of techniques and processes for the successful translation of this technology into the clinic.

The position requires a capacity for constant innovation in pursuit of company goals, creativity, and adaptability. The environment is exciting, fast-paced, and offers the opportunity to work at the cutting edge of gene therapy for rare CNS diseases and small molecule development for cancer.

Responsibilities:

  • –  Management of CROs for CNS centric in vitro and in vivo studies
  • –  Protocol development for in vivo studies in disease models
  • –  In vitro testing of patient-derived iPSC and differentiated cells
  • –  In vitro testing of AAV lead designs
  • –  Oversight of small molecule lead compound validation in vitro and in vivo
  • –  Understanding and interpretation of patient-related data and its integration with experimental and therapeuticdesignRequirements:
  • –  Ph.D. in CNS biology or related field
  • –  Experience with CNS-targeted AAV gene therapy and the generation/use of AAV gene delivery vectors
  • –  Proficiency in brain physiology / pathology
  • –  Extensive experience with mammalian cell culture
  • –  Mastery of basic molecular biology and biochemistry
  • –  Strong communication and data presentation skills
  • –  Ability to work in a team-oriented, multidisciplinary environment

Chief Financial Officer -Boston/NY/San Francisco

Several of our Biotech client have reached out to discuss 2019 CFO hires.

For consideration or to set up time to discuss, please contact

tsharon@tseworldwide.com

Associate Director, Forecasting & Analytics

Bay Area, CA

Position Summary

The position will be based in Palo Alto and will report directly to the Vice President, Commercial Analytics.

The Associate Director, Forecasting & Analytics will be responsible for design, development, oversight and delivery of global forecasting process/initiatives, for the portfolio. This person will be an integral partner to the business operations (Finance and Supply Chain), as well as the commercial teams (Marketing,Market Access, Market Research, Sales and Operations).

Key Responsibilities
In close collaboration with Finance, deliver complete, accurate, validated, and timely forecasts
Develop and maintain a robust commercial forecasting capability to
ensure internal and external alignment on business expectations
Operationalize forecasting governance and processes and then leading
the execution of these
Develop revenue and supply/demand forecasts in support of financial
planning processes, i.e., Operating Reviews and budgeting processes
Contribute to annual, short-term, and long-range planning forecasts
Manage all aspects of new launch, inline and portfolio forecasts includingdeveloping and maintainingepidemiology and prescription-based modelsLead the development of evidence-based forecast scenarios in driving
strategic decisions.
Carry out base-case and scenario analyses (TPP’s, launch year, market share, price, sales ramp, etc.) to support decision making by key partners
and stakeholders including Commercial, Business Development/Strategy, Finance, Manufacturing, and executive leadership, BOD, etc.
Conduct and incorporate ad hoc analyses of forecast sensitivity which
may involve estimates of monthly demand for in-line products using
weekly data and/or risk and opportunity sizing
Collaborate across functions to ensure inputs and assumptions are captured and documented in forecasts,
drives alignment on financial projections, and secures approval from
senior and executive leadership
Incorporate the results of primary research into the forecast model(s) to
reflect anticipated risks andopportunities
Use patient flow forecast models, patient based forecast models, and statistical trending and ensure alignment on forecast assumptions and other
critical analytical assessments with business partners
Ensure that forecasts address the impact of market dynamics and critical events, are logically designed andwell documented
page2image2431123968
  • Implement quality control processes into the forecast process
  • Identify key business issues that impact short-term and long-range product and market forecasts; clearlyand pro-actively surface these issues
  • Lead national-level performance reporting and diagnostics including reconciliation with forecasts; will ownnational analytics data sets; will partner with Market Research counterpart on key business analysis (proactive and reactive), in responding to key business questions and in commercial reporting and launch tracking/monitoring
  • Present findings and make recommendations to management regarding: brand, market growth, inventory dynamics, patient incidence, prevalence, diagnosis, treatment trends, competition and payer environment
  • Demonstrated excellence in consensus building, characterizing and communicating uncertainty, and be able to explain issues from aggregate trends to modeling mechanics
  • Participate in ad-hoc projects by working collaboratively across product teams and other functional

departments
• Stay abreast of novel forecasting and analytical methodologies and processes

Knowledge, Skills, and Experience

  • Bachelor’s Degree required; Master’s Degree or MBA preferred
  • Minimum of 8 years of forecasting and modeling experience
  • Experience in Specialty or Rare Disease, preferred
  • Superior analytical skills with proficiency in a broad range of data analysis and intelligence generation
  • Significant expertise in analytics, forecasting, modeling methodologies and a solid understanding ofcompetitive intelligence and market research
  • Ability to run statistical analyses, contribute to new analysis methodologies, and engage withanalytics/statistical modeling experts
  • Advanced knowledge of MS Office (Excel, PowerPoint, Word) and strong ability to present quantitativedata in graphical form is required
  • Strong team player with ability to manage conflicting priorities
  • Demonstrated ability to work with many cross-functional partners
  • Ability to understand and influence decisions
  • Ability to interact and communicate with all levels in the organization
  • Self-starter. Proactive in nature, actively participates and self-motivated
  • Excellent project management skills with demonstrated ability to lead multiple projects and priorities
  • Demonstrated ability to work effectively in cross-functional teams is required with a history of leadership,initiative in achieving organizational objectives
  • Strong communication/influencing skills and executive presence required
  • Ability to travel up to 10% of the time domestically and internationally

Gene Therapy News

After a recruiting journey with candidates from Europe, Asia and all over the US, I am happy to announce that our client Grace Science, LLC has selected a Bay Area local to lead their ambitious R&D effort in Gene Editing/Gene Therapy, Rare Diseases, Neuromuscular and Oncology. It has been a privilege to work with the team and I am certain great things are to come.

For more information about Grace Science and their technology please visit