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

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. 

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

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

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

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

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

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

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/

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

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

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

Executive Medical Director- NY Biotech

Executive Medical Director- NY (Immunotherapy)

Job Description

Works with the CMO, CSO and the CRO team members to develop and translate clinical strategy into trial options and protocols.

Performs clinical monitoring of one or more studies.

Conducts Medical Data Reviews (and data cleaning support as appropriate) of ongoing studies working with clinical operations and data management groups.

Addresses relevant clinical queries from study sites with documentation.

Identifies and builds relationships with investigators.

Contributes to Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).

Supports generation and coordination of clinical documents and deliverables in support of regulatory filings.

Responsible for the study timelines in a cross-functional matrix protocol team.

Responsible for the clinical development activities from site(s) initiation to study discontinuation.

Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements.

In collaboration with the CMO and CRO, designs and implements safety monitoring plans.

Interprets clinical data and makes appropriate decisions and recommendations.

Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions.

Work with the Program Lead, team members and governance bodies to translate the strategy into trial options, protocols and action plans.

Work with the investigators to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview.

Works consistently in a matrix environment.

 Qualifications and Requirements

MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology and cell therapy, or equivalent therapy area knowledge

Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry – e.g. monitoring)

Management of one or more uncomplicated studies and preparation of regulatory documents

Relevant clinical research experience (relevant academic research experience could potentially substitute)

Possesses a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock

Possesses a history of handling multiple, complex, studies in parallel

Possesses a history of prior meaningful participation in regulatory submissions

Possesses a history of strong interaction with thought leaders

Proven team leadership capability

Performs as an individual contributor

Identifies when an issue is present and begins to address

 Essential Leadership Behaviors

Identify and builds relationships with study investigators

Is seen and acts as the study expert by the site personnel

Ability to work and communicate efficiently with internal partners in the US for positions located outside the US

Identify and builds relationships with principal investigators

Identify Thought Leaders and use them for inputs in clinical strategy and protocol design

Maintain a strong medical/scientific reputation within the disease area

Contribute to interactions as a medical monitor on assigned clinical studies

Share specific clinical strategies with CMO and CSO

Study-specific clinical design and execution

Manage communication with key stakeholders (senior)

Candidates should email CV and cover letter to jobs@tseworldwide.com

 

Director Segment Marketing – Oncology

Director Segment Marketing – Oncology; NJ
The Director Segment Marketing will leverage business acumen, a strong knowledge of the US Market Access Customer Base, and market access research/VAP field team insights to identify where branded and/or non-branded programs and resources can be developed in support of strengthening partnerships and collaboration with critical customers (such as Managed Care Organizations, Organized Customers (Integrated Delivery Networks, Hospital Systems, Medical Groups).
The Director Segment Marketing will lead a team of BU-aligned Segment Marketers and drive the development of these branded and/or non-branded messaging, tools, and resources that deliver value for access customers while enhancing customer engagement and portfolio access opportunities for VAP customer-facing field teams.
The purpose of the VAP Segment Marketing team is to address unique Opportunities & Needs of Prioritized VAP Segments and Channels to Drive Business Performance (“Right Message to the Right Customer, at the Right Time”).
Potential deliverables for VAP Segment Marketing may include:
Strategic Assessments: Evaluation of Specific Segments, Channels, or Stakeholders
New Tools and/or Modifications of Existing Tools
Commercial Customer Collaborations Non-Personal Promotion or Third Party Partnerships
Key responsibilities for the Director Segment Marketing will include:
Ensuring the development and execution of BU-specific Segment Marketing deliverables
Management of Segment Marketing budget and integration of Segment Marketing deliverables into VAP Strategic Payer Marketing annual marketing cycle
Ensuring Segment Marketing deliverables are aligned with brand strategies, VAP Strategic Payer Marketing partners/leadership, and VAP field team needs
Managing, coaching, and mentoring Segment Marketing team in alignment with People Strategy principles
The Director Segment Marketing will be expected to adhere to Core Behaviors and also commit to regular and close collaboration with VAP Strategic Payer Marketing teams (Payer, Quality/Policy/Population Health, Value Marketing) and VAP Strategic Payer Marketing and field leadership.
For consideration please email resume and introduction to jobs@tseworldwide.com

Head of Translational Development


The candidate will be responsible for both therapeutic areas: Oncology & Immunology. As the functional head of Translational Development , they will be at the interface with the Discovery and Development teams, with the aim of providing the successful implementation of stratification strategies, clinical biomarker and pharmacodynamic assays in the early clinical development phases.


Technical Skills:

   • Collaborations that impact all of research, or even across multiple functions.
   • Scientific and technical expert.
   • Proven track record of success in drug discovery and development.

Responsibilities:

   • Cell panel screening: define resistance mechanisms, sensitivity elements, PD markers and potential biomarkers of response
   • Genomics analysis from human clinical samples, cell screen samples and clinical trial support (defined clinical experiments from the development teams). This includes development of a high dimensional bioinformatics.
   • Clinical PD or Biomarker assays, translated from discovery (if applicable or appropriate) or developed specifically for early clinical use, assessing feasibility and applicability for companion diagnostics
   • Application of model systems (in collaboration with the disease biology and in vivo pharmacology groups) beyond those routinely employed by discovery teams that aid in patient stratification/response and compound use, either        in-house or as a collaboration
   • Translational Development representation to the Development Project teams
   • Participate in formulating disease area strategy for target selection and validation
   • Evaluating, in conjunction with BD and the established teams, the potential in-licensing opportunities that may include potential therapeutics, emerging technologies, processes or capabilities that will enhance our Drug Discovery and Early Development efforts.
   • Being part of the team responsible for establishing key alliances with academic centers, co-operative groups and government agencies for cost effective implementation of  R & D and early development strategy

Qualifications:


   • Track record in large and small companies, leading innovative efforts to deploy technologies and assays for enhanced translational capabilities
   • Excellent communication, managerial and scientific qualities are expected
   • Ability to interact effectively across boundaries using influencing and relationship building skills.
   • Competence in analysis and solving of problems, and the ability to prioritize and make tradeoffs to achieve goals.

Other Attributes:

   • A problem solver who creatively and knowledgeably transcends departmental function to act as a resource to entire research effort and senior managers in development.
   • Identifies issues early and proposes innovative solutions.
   • Communicates within the larger organization and external community.
   • Provides expert guidance to multi-disciplinary teams and senior management.
   • A leader whose scope of influence stretches across.
   • A leader who influences external scientific community.

Requirements & Education:

   • MD, DO or PhD
   • 10 years industry experience

Associate Director, Translational Medicine – NYC

 Position Overview

The Translational Medicine Specialist is a core member of our Antigen Map team and is responsible for advancing scientific insights into viable clinical products. This leader will develop and execute translational strategies for furthering the development of next diagnostic products, with opportunities in infectious disease, autoimmunity and oncology. The successful candidate will work cross-functionally to develop a clinical development strategy across potential applications in alignment with Antigen Map team leadership. The Translational Medicine Specialist will also develop and manage clinical protocols and validation in clinical data sets that meet regulatory requirements.

Key Responsibilities

  • Serve as the dedicated translational medicine lead for the Antigen Map project
  • Help develop strategy for the Antigen Map program to ensure alignment between R&D objectives and unmet medical need
  • Support clinical development and validation of new diagnostic products
  • Develop and lead sponsored clinical protocols to test key hypotheses
  • Represent us externally and deliver scientific presentations
  • Support cross-functional teams to broaden existing and secure new clinical opportunities
  • Serve as a clinical resource to internal stakeholders such as business development, research, computational biology, marketing and sales

Experience and Skills:

  • MD with a minimum 3 years of experience, with a minimum 2 years of experience in translational and clinical research (can be Academic)
  • Deep understanding of translational research/medicine and clinical diagnostics
  • Demonstrated experience in the application various scientific technologies into translational research strategies
  • Demonstrated scientific acumen and mechanistic understanding of disease biology
  • Working knowledge of FDA guidance for the Dx and Rx industries
  • Ability to manage multiple projects and engage with diverse stakeholders in a dynamic environment within tight timelines
  • Ability to think quantitatively, interpret clinical data and interact with computational biologists and biostatisticians
  • Strong interpersonal and presentation skills, good judgment and ability to communicate with a diverse range of individuals
  • Excited about an early stage company environment and driven to make a difference
  • Strong work ethic with expectation of excellence from self and others

Director, Clinical Development – Immunotherapies

Job Description
– Leads and participates in cross-functional oncology drug development matrix teams.
– Designs and develops proof-of-concept research plans, develops Phase I/II and clinical pharmacology protocols, leads the execution of clinical studies and interpretation of data and makes appropriate recommendations based on these data.
– Serves as a medical and scientific expert to drug discovery teams and contributes to selection of discovery compounds, development of clinical strategy and transition of compounds into early phase development.
– Contributes to the writing, review and publishing of reports submitted to regulatory agencies.
– Serves as one of the company’s scientific and medical experts and represents client at advisory boards and public forums.
– Participates in licensing teams in the evaluation of clinical or preclinical external opportunities.
– Builds relationships with thought leaders and principal investigators and gathers input on disease areas and design of clinical programs.
– Contributes to continuous improvement initiatives, effective team-building and effective communication across the oncology community.
Qualifications
Requirements:
– M.D. degree, Board Certification in Internal Medicine and Oncology or related fields, and knowledge of both basic science and clinical oncology.
– Extensive experience in Oncology drug development including the design, conduct and analysis of clinical trials.
– Experience in Clinical Biomarkers and Clinical Pharmacology preferred.
– Strong leadership skills with proven ability to lead and work effectively in a team environment.
– Excellent communication skills, ability to deliver effective presentations, strong networking abilities and creativity are essential requirements.
qualified candidates should send CV to jobs@tseworldwide.com

Head of Clinical Development – Immunotherapy and Biomarkers

Head of Clinical Development – Immunotherapy and Biomarkers

RESPONSIBILITIES

  • Provide clinical leadership and focus for R&D to ensure the creation of comprehensive product development plans from concept to launch
  • Develop actionable plans with anticipate regulatory requirements and timelines to support validation and labeling efforts
  • Provide timely product development requirements to operations which will support scaling infrastructure and capacity to support new product/market needs.
  • Experience writing and implementing research protocols, reviewing and interpreting data, preparation of study reports, data analysis and presentation of data to internal and external audiences.
  • Ability to work in a matrix environment with other departments to include Project Management, Regulatory Affairs and Medical Affairs.
  • Excellent oral, written and personal communication skills.
  • Strong clinical research, leadership and management experience
  • Demonstrated experience leading collaborations with RA, QA, R&D, Medical and Commercial to successful product launch.

please email CV to jobs@tseworldwide.com

Genomics / Diagnostics Careers

Our genomics clients are growing rapidly and we are looking for the following:

 

  • Director – VP level candidates – Pharma Partnering; Nationally and possible EU
  • Site Head- San Francisco Bay Area and additional locations
  • VP, Translational Development – Oncology and Immunology – location open (multiple)
  • VP Clinical Development – Oncology and Immunology – location open (multiple)

For details and consideration, please send a note to tsharon@tseworldwide.com

 

 

Executive Director, Oncology Global Clinical Research

Job Description

The Global Clinical Research  Executive(s) will set the clinical research strategy for ensuring broad development of oncology assets and leads and supervises the clinical research efforts for one or more oncology or immuno-oncology assets and/or one or more tumor indications. He/She will create and communicate a vision for clinical development of the oncology pipeline assets, including I-O.  He/She will lead and develop a group of clinical research professionals (including several physicians) whose therapeutic area focus is in oncology and will ensure scientific and technical excellence of clinical development programs and deliverables. This successful leader will supervise the development, medical monitoring, interpretation and analysis of and clinical trials and protocols and will supervise the clinical development components of all regulatory filings. The role will report directly to the Head of Oncology Global Clinical Research. The successful candidate will contribute to overall oncology and oncology tumor strategy and also be a member of Oncology Development Senior Leadership team (SLT).  He/She will provide strategic insight and the clinical development plan, to business development due diligence efforts, and advice to our strategic transactions group. The successful leader will partner and interact with colleagues from Early Development who design and implement first in human through proof of concept trials and will to assure a seamless transition into late stage development (Phase II-III trials.)   As an oncology development leader, this individual will be responsible for creating a clinical program strategy to development drugs beyond commercialization and launch and into lifecycle management. He/She will work closely with colleagues in our Research, Development, Regulatory, Medical, Commercial and other key functional areas on a global basis; additionally he/she should have an external focus and build relationships with thought leaders, physicians, and patient advocacy groups outside. He/She will guild a franchise reputation that attracts innovators to bring their ideas. This individual will recruit, develop and retain strong talent. He/she will establish an effective and ethical culture that encourages teamwork, promotes cooperation and provides a supportive culture. This individual will be responsible for developing a culture that values diversity of thought, supports coaching, fosters accountability and integrity, and supports process excellence and continuous improvement. This executive will have shared responsibilities across the Oncology Development Center executives (e.g. tumor strategy, the Protocol Review Committee, external speaking engagements, business development, talent management, etc.)
Qualifications:   The ideal candidate will be a physician leader, preferably board certified in oncology or related specialty with extensive oncology clinical trial and drug development experience in addition to a strong scientific background. The successful candidate will understand early-stage drug development issues, extensive experience designing and conducting Phase II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval. Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience. The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory. The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment. Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies. Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy. In addition, the candidate must be skilled at interacting externally, and at speaking engagements. He/She must be skilled at attracting, developing, and retaining skilled professionals who fit the our culture.

 

Qualifications

Qualifications:   The ideal candidate will be a physician leader, preferably board certified in oncology or related specialty with extensive oncology clinical trial and drug development experience in addition to a strong scientific background. The successful candidate will understand early-stage drug development issues, extensive experience designing and conducting Phase II and Phase III clinical trials, and should have demonstrable success filing regulatory dossiers and prosecuting them through approval. Management experience will be important since this individual will manage a group of professionals including MDs or PhDs or PharmDs with clinical research experience. The candidate also must be a highly effective leader capable of working with Commercial, Medical, and all research functions of the company from Research through Regulatory. The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment. Global experiences is a plus since this position has responsibility for strategy and clinical research in oncology in multiple geographies. Experience interacting with business development and licensing, particularly helping to evaluate the technical and franchise aspects for potential in-licensing opportunities that shape the oncology clinical development strategy. In addition, the candidate must be skilled at interacting externally, and at speaking engagements.

Sr. Medical Director, Clinical Development

New opportunity in NJ:

  • Marketed effective treatment for cancer looking to new indications.
  • World class, highly respected executives under which to learn and design trials.
  • Excellent opportunity to work with Clinical, Medical and Commercial

to learn more please contact jobs@tseworldwide.com

 

 

 

Senior Medical Director, Life Cycle Management The Head of Life Cycle Management

Senior Medical Director, Life Cycle Management The Head of Life Cycle Management (LCM), Global Medical Affairs _Cambridge, MA

is a high visibility, strategic and operational leadership position reporting to Head MS Global Medical Affairs. This is an exciting opportunity to work in a patient-centric, high performance culture. The Head of Life Cycle Management, Global Medical Affairs will be a member of the MS Global Medical Affairs team, providing input into novel life cycle management opportunities for products in Phase IV and the commercialized portfolio to ultimately improve therapeutic and compliance benefits to MS patients while expanding the development pipeline. The Head of LCM has a crucial role in the development of the yearly Global Medical Affairs Plan, making sure the LCM strategy is aligned with the identified critical success factors. He/she will work in a matrix participating as a member of various Medical Affairs, Clinical Sciences & Operations (CSO), and cross-functional teams and committees to further strengthen the Ph. III b and IV study development of the MS Franchise. Partnering with and providing input to Product Lead(s) and Launch/Commercial Team(s) to define global product launch and life cycle management strategy to impact the achievement of objectives and maximize the value of each product in the franchise is a critical component of this role. The Head of LCM will partner with Clinical Sciences & Operations (CSO) teams while being responsible for coordinating, overseeing, and providing guidance to the MA teams throughout the organization to guarantee seamless and timely execution of the Ph. III b/ Ph. IV program of Genzyme sponsored studies (GSS). This will include managing a team of professionals (MDs, PhDs, project managers) driving the LCM working group across the organization for our current franchise and becoming involved in new programs as they reach Ph. III to strengthen the pre-launch efforts. Support the successful launch and life-cycle management of Genzyme’s marketed product portfolio through innovative thinking and approaches in all areas including Genzyme sponsored studies (GSS) as well as independent research projects to generate data on drug MoA, long term benefit, long term safety, and patient reported outcomes, in close alignment with the Global Medical Affairs Plan. The Head of Life Cycle Management co-chairs the Scientific Review Committee for both Genzyme and Investigator’s initiative studies, coordinates synopsis development for the GSS, provides input into the yearly defined ISS strategies for each of the MS drugs, and coordinates the ISS monthly updates. The exceptional leader that we seek will be responsible to: •Provide leadership to Ph. IV programs to define life-cycle management strategy identify needs for high value post-marketing clinical trials and registries and oversee their management and execution.

•Develop medical strategies to obtain relevant data evidence from company and Investigator Sponsored Studies (ISS), including Real World Evidence, consistent with strategic objectives for each product. Ensure that appropriate processes are in place for review, approval, management and support of studies while maintaining investigator independence.

•Communicate product life-cycle management strategy to regional/local Medical Affairs experts and product managers. Ensure that studies planned by regional and local affiliates fit into the global product strategy.

•Ensure and oversee the planning, execution and reporting of clinical studies as defined in the Global Medical Affairs plan and in accordance with established budgets and timelines. Monitor performance of phase IV activities (e.g. value creation) from conception through publication of clinical study results and take corrective actions or escalate issues as appropriate. Contribute to continuous improvement of phase IV study related processes and best practices.

•Lead/co-chair team(s) responsible for peri-/post-approval data analyses and evaluations to ensure appropriate prioritization of resources and effort towards generation of medical-scientific results in support of key publications, health authority and market access requests, as needed.

•Establish a strong network within the MA organization (Global, Regional and local) and also with other stakeholders namely the R&D, the Clinical Sciences & Operations (CSO), and Pharmacovigilance teams. •The financial management and reporting requirements of LCM studies and ISSs with accurate and timely data and assumptions to support budgeting, forecasting and long range planning for the business unit. •Represent the Global MS Medical Affairs team at medical meetings, advisory boards, outreach meetings at key institutions, and in interactions with KOLs. Basic Qualifications

•Either advanced degree (e.g. MPH, PhD or M.D.) combined with industry experience working in related areas (e.g. LCM, Clinical Development, Project Management, etc.), preferably related to MS. Well established leadership and management skills in attracting, mentoring and retaining high performing medical affairs professionals.

•Experience in managing clinical trials in a pharmaceutical or equivalent environment is strongly desired. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management, regulatory requirements and compliance for conduct of clinical research essential.

Preferred Qualifications

•Demonstrated ability to work effectively in a matrix environment.

•Excellent skills working cross functionally, specifically partnering with all the internal and external stakeholders.

•High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.

•Comfort operating in a consensus building role but also able to make critical decisions and drive these decisions through the organization. 

Sr Medical Director – Oncology Colorectal Cancers – Immunotherapy

Director/Sr. Director, Global Product Medical Leader to support colorectal cancer products, and  plus selected products in the Oncology pipeline. Assignment of pipeline products may be influenced by the successful candidate’s past experiences and areas of expertise.  The new Director/Sr. Director will report directly into the Vice President, Global Medical Affairs Oncology.

The ideal candidate will have the following mix of professional and personable characteristics:

  • Multiple myeloma expertise
  • MD, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology.
  • Industry experience in Medical Affairs is preferred.
  • Sound scientific and clinical judgment, including in-depth understanding of the scientific method and clinical applications based on medical, scientific, and practical rationale.
  • In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials.
  • Broad and formal leadership experience, including excellent “leadership presence” to represent Medical Affairs within the company, to other functions, and to leaders at every level.
  • Excellent skills working with experts from other functions and countries and influencing decision making without authority in a complex and matrix environment.
  • High energy and an absolute commitment to a culture that operates with high ethical standards and strives to exceed all goals and objectives.
  • Demonstrated ability to inspire confidence while working effectively in a matrix environment.
  • Comfort operating in a consensus building role but also able to make specific recommendations and decisions and drive for implementation.
  • Ability to inspire confidence, both internally and externally – leading by example and demonstrating collaborative behavior.
  • Demonstrated ability to organize and lead expert Clinical Research Advisory Panels.
  • Ability to understand and effectively communicate scientific and medical data results and information to internal and external stakeholders.
  • Excellent communication skills with the ability to build solid working relationships with the commercial organization, as well as negotiate and influence across cultures.

Apply by emailing resume to jobs@tseworldwide.com

Director, Medical Affairs – Immuno-Oncology

  • MD, Board Certification in Oncology/Hematology or Pediatric Oncology/Hematology.
  • Immuno-oncology treatment expertise
  • Industry experience in Medical Affairs or Clinical Development.
  • Opportunities with clients in NJ, PA, MA, CA and WA

Please send message to jobs@tseworldwide.com for client disclosures

Senior /Vice President, Clinical Research, CD4+CD8; Oncology

NY Biotech

Responsibilities/Requirements

• Provide therapy area medical and scientific expertise, translating complex scientific concepts and data while providing a strategic point of view. 
• Execute the planning and management of innovative clinical trials, study design, trial management, and interpretation of trial results. 
• Engage and inspire the cross-functional program teams through communication of strategic plans and vision. 
• Cultivate and nurture strong collaborations, relationships, and support with Investigators, Academic partners and KOLs. 
• Partner with Business Development to evaluate the scientific and strategic value of the external collaboration opportunities. 
• Prepare, estimate, and manage the section budget, proposing priorities to management and ensures the allocation of resources. 
• Lead, supervise, and facilitate the professional training and development of the physician team; conduct reviews and evaluate the performance and compensation of direct reports. 


Basic Qualifications:

Qualification and Education Requirements 
• MD with 6+ years of pharmaceutical or biotechnology industry experience in oncology clinical development; experience in early phase development. 
• Expertise in clinical hematological malignancies; fellowship trained Hematologist or Hematologist/Oncologist. 
• Experience designing, conducting Phase 1-2 clinical trials in oncology. 
• Proven experience in leading project and clinical study teams in industry setting. 
• Understanding of cellular immunology and typical assay systems for same 


Qualified candidates should email CV/Resume to jobs@tseworldwide.com