Category: Physicians

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

Executive Director, Clinical Development

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

Job Duties & Responsibilities

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

Essential Qualifications

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

Preferred Qualifications

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

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

Sr. Vice President, Commercial (Offer Accepted)


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

Bay Area Biotech – COO or CBO

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

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

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

CSO/Head of Discovery AutoImmune Rare Disease

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

Job Description

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

Responsibilities

Preclinical

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

Clinical

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

Requirements

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

Not required, but desired

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

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

Executive Director, Late Phase Medical Lead


Executive Director, Late Phase Medical Lead

Position Summary

The Executive Director , will provide global support for strategic planning and leadership in our metabolics program for Rare GI. He/She will be responsible for providing strong scientific and medical support with an in-depth understanding of the Metabolics medical landscape, particularly in the designated therapeutic areas. He/She will also support the development and implementation of the short and long-term strategy, practices and infrastructure for Global Activities, aligning with overall medical affairs strategy and effective cross-functional collaboration, namely on the development of phase IIIB/IV research, Advise seeking activities, Patient Engagement, Materials, etc. Support the Global Medical Affairs mission to maximize patient outcomes by setting and continuously advancing the evidence-based medical standard of care.

Job Duties & Responsibilities

Develop and implement global medical strategy and plan for GMA activities (pre-launch and post -launch as applicable) for the Metabolics by providing medical leadership, insight and strategy to the global medical affairs team across functions and countries globally. Responsible for the following:

  • Develop in-year global medical strategy, Implementation and budget plan for global initiatives
  • Lead on the situational assessment and the global product strategy development including harmonization of activities involving KOLs.
  • Provide medical strategic recommendation for in-line life cycle management (LCM) and late phase pipeline programs
  • Development and execution of major registration LCM program and geographically expansion strategy
  • Develop Phase 3b/4 and ISR evidence generation strategy for late phase pipeline and in-line TA programs
  • Develop and oversee clinical study design (non-registration phase IIIb/IV, registries, outcomes research etc.) for late phase pipeline and in-line Metabolics programs in close collaboration with relevant functions
  • Provide medical review and ensure alignment with Metabolics strategy of Investigator sponsored research (ISR) proposals including the review of the Final Report
  • Provide clear strategic guidance to scientific communication, internal medical training, external medical education (CME, Symposia, medical education), Medical info, PEVT teams in developing functional plans supporting global medical strategy
  • Develop medically appropriate commercial strategy/tactic, planning and execution
  • Provide global medical guidance to country medical teams in developing country medical plans aligned with global medical strategy
  • Collaborate with country medical Metabolics lead to ensure local activities are aligned with global medical strategy and that Global Medical is sufficiently aware of country insights and needs. Alignment among Global and Country Medical Plans, adjust if needed.
  • Monitor team performance in terms of goals and delivery of global medical plans
  • Serves as the medical expert and resource within ALXN in support of the therapeutic area.
  • Lead content development and presentation for external medical education programs, and other Global Medical initiatives
  • Develop, conduct, or participate in therapeutic training programs for personnel.
  • Medical affairs review materials
  • Independent review of Medical Grant requests including CME, symposia and others.
  • Medical affairs review of post approval regulatory responses and annual safety reports
  • Medical affairs review of reimbursement and value dossiers
  • Medical affairs review of congress abstracts and publications
  • Establishes strategic partnerships with centers of excellence and KOLs in areas of scientific interest and serves as conduit for flow of information both out to the medical community and into the company. Responsible for the following:
  • Development and execution of Global KOL medical engagement strategy
  • Provide Metabolics KOL engagement strategy and guidance to country medical teams in developing country KOL engagement plans
  • Establish and/or enhance partnerships with key academic institutions and develop relationships with global key thought leaders
  • Planning, designing and managing global medical Advisory Boards and gather insight from regional/local medical Advisory Boards
  • Responsible for the Global and Country Quarterly Management Review and will be consulted on defining Country-Specific Medical Plan.

Essential Qualifications

  • Disease and Product Expertise (preferably with background on Neurology, Endocrinology, Hepatology or Internal Medicine)
  • Experience leading Medical Affairs function
  • Proficient in Medical Governance and operations, with extensive regulatory and compliance experience leading a Medical Affairs organization
  • Strong people management and leadership skills acquired in a multicultural environment
  • Excellent communication skills both written and verbal.
  • Ability to lead and motivate a team, both internally and remotely
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective a team member and project leader
  • Previous Clinical Operations experience (design and implementation of clinical trials)
  • Proven ability to manage budget and resources
  • Strong business acumen
  • Ability to build partnership access between HQ and affiliates
  • Flexibility and ability to adapt to changing conditions
  • Excellent problem solving, organizational, and negotiating skills
  • Must demonstrate an energy and enthusiasm which brings a positive approach to all challenges Sense of ethics and responsibility
  • Fluent in English
  • Travel required up to 25% to 35%

Preferred Qualifications

  • Scientific and technical acumen in Neurology, Hepatology, Gastrenterology, Lipidology and/or Bone Metabolism
  • Fluency in Spanish or Portuguese is a plus
  • Health Outcomes Research/Reimbursement Experience
  • Regulatory Affairs
  • Clinical Development Experience

Education

  • Must have a MD, PhD or PharmD level degree or equivalent
  • 3 years + experience in medical affairs/R&D organization ( Development, Phase IIIB/IV, med info, grant processing, ISR review, field Experience, Global KOL management, scientific communications & publications)
  • Experience leading cross-functional teams
  • Experience managing people
  • Experience in the Pharmaceutical or biotechnology industry

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

Sr. Scientist-PK/PD

Boston, MA

Position Summary

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

Job Responsibilities

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

Qualifications

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

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

Director, Global Marketing, -Neuromuscular

Director, Global Marketing, -Neuromuscular (Location Open)

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

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

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

Job Description:

ESSENTIAL FUNCTIONSPrimary duties/responsibilities:

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

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

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

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

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

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

Head of Developmental Sciences – San Diego

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

Key Responsibilities

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

Education & Experience

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

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

Director, Program Management –NJ

Director, Program Management – Gene Therapy

Summary of Position

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

Roles and Responsibilities

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

Qualifications and Background Requirements

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

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

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

Executive Director, Rare Disease Product Development

Executive Director, Product Development, Bay Area

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

Role:

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

Key Responsibilities:

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

Education:

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

Experience:

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

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

RESPONSIBILITIES:

Reporting to the Chief Development Officer the successful candidate will:

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

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

Chief Medical Officer – Oncology; CT

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

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

Additional responsibilities required include:

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

Qualifications

Education and Experience: 

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

Knowledge and abilities:

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

Additional information

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

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

VP; Pharmacovigilance

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

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

Knowledge, Skills and Experience

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

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

jobs@tseworldwide.com

Gene Therapy – Leadership Opportunities

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

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

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

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

Please stay tuned for updates here and on LinkedIn

Feel free to email me as well Email

 

 

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

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

S/VP – Clinical Development

VP/SVP -Clinical Development (Rare Genetic Diseases)

Boston or Cambridge, MA

The VP/SVP Clinical Development (Rare Genetic Diseases) will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

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

Interested candidates should email CV to tsharon@tseworldwide.com

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

 

VP/SVP -Clinical Development (Rare Genetic Diseases)

Boston or Cambridge, MA

The VP/SVP Clinical Development (Rare Genetic Diseases) will be responsible for all clinical development and regulatory strategy and execution and will be tasked with advancing novel medicines through clinical trials.

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

Interested candidates should email CV to tsharon@tseworldwide.com

Vice President, Medical Affairs

Vice President, Medical Affairs, Palo Alto, CA

Vice President, Medical Affairs who will lead the development of the Company’s medical strategy for commercial products and work closely with other Departments including Commercial leading the development of the Company’s medical affairs strategy for all to be marketed products. S(he) will be responsible for designing and implementing medical strategies and tactical plans while providing thought leadership and tactical execution for medical publication planning, medical education, medical information system development, field medical liaisons and medical communication. S(he) will also work closely with the safety and pharmacovigilance professionals and strategic alliance partners.

With the Chief Medical Officer and Chief Commercial Officer, the VP, Medical Affairs defines strategy and will develop and refine Medical Affairs policies and procedures and SOPs, to ensure and maintain excellence in standards and practices. The VP, Medical affairs will provide significant support for phase 2/3 recruiting activities across all products, lead the company’s KOL advisory board management, and run the investigator-initiated trials program. Additionally, the VP, Medical Affairs will design and execute on phase IV studies and, when appropriate, lead the phase IV clinical program. This position will report to the Chief Medical Officer, Clinical & Regulatory.

Specific Responsibilities

  • Develop and implement the US and global medical affairs plan across products
  • Develop and refine Medical Affairs policies and procedures and SOPs
  • Work closely with commercial and clinical development/regulatory in designing and implementing launch strategies and tactics, and life cycle planning
  • Provide assessments of product opportunities and threats
  • Develop strategic imperatives and tactical plans to enhance healthcare practitioner education to improve patient outcomes
  • Provide leadership to the Medical Affairs team and actively lead the design and conduct of Phase IIIB/IV trials and medical materials review.
  • Provide medical expertise in development of promotional materials.
  • Develop strategy for review and approval of investigator-initiated studies
  • Develop strategy for review and approval of CME programs
  • Conceive, structure, and conduct of US advisory boards and steering committees
  • Foster research relationships with key research centers in the US
  • Interact regularly with key medical opinion leaders
  • Work with commercial colleagues to develop and implement the company’s publication strategy
  • Collaborate with Commercial, Legal, and Regulatory for development and review of labeling, advertising and promotional materials
  • Monitor the competitive environment to sustain expertise in therapeutic area treatment management and new therapies, competitive products and features
  • Contribute to coaching and training Medical Science Liaisons and related sales force personnel on company clinical, medical, and scientific matters

Position Requirements & Experience

  • MD degree, with specialization in endocrinology preferred, and pediatric endocrinology highly desirable.
  • Experience with hGH treatment in pediatric GHD preferred.
  • Experience designing and executing clinical trials
  • Experience with GHD clinical trials a plus.
  • Excellent understanding of the drug development process and GCPs.
  • Strong clinical/scientific background/aptitude.
  • Prior experience in meeting the high standards required for drug development within a regulated environment consistently.
  • Previous pharmaceuticals industry experience in a Medical Affairs leadership role
  • Previous launch experience would be ideal with past success working in highly matrixed, cross-functional environment requiring excellent cross functional collaboration to achieve successful results

Personal Characteristics & Cultural Fit

  • Strong writing and presentation skills.
  • Team player and highly collaborative with executive team, colleagues, investigators, and clinical research partners.
  • Ability to follow complex direction/processes under pressure.
  • Proficient balancing multiple routine tasks simultaneously to achieve goals.
  • Very strong organizational skills, with attention to detail.
  • Works well under general direction, with ability to independently determine and develop approaches to non-routine problems – a self-starter.

Executive Director; Medical Strategy

Executive Director; Medical Strategy- Boston

Duties and Responsibilities: 

  • Serve as U.S. Medical Director for multiple global clinical development trials and/or U.S. Medical Affairs Trials (including phase I-IV, Expanded Access, Investigator Initiated, registries and Compassionate Use).  Interface with Global and U.S. Clinical Team Members, Clinical Operations, Scientific Operations, Regulatory Affairs, Drug Supply, Data Management, Finance, Quality, Compliance, and other relevant functional areas as well as Partners.
  • Design and optimize clinical trial design and ensure clinical trials meet ethical and regulatory standards including:
    • Write and review protocols that are in-line with the overall indication strategy.
    • Conduct medical review and interpretation of efficacy and safety data from clinical trials.
  • Responsible for the quality, coordination, medical accuracy, and timeliness of clinical study reports, clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, clinical expert reports, and label reviews.
  • Review and provide US feedback to Global Protocols and Global Development Plans.
  • Develop strategy for US Medical Affairs including exploratory indications and integrate US plan with overall Global Medical Affairs strategy.  Oversee the review and approval of IIT concepts. Oversight during the conduct of trials including safety monitoring.  Review of interim and final publication, manuscripts, or abstracts.
  • Provide strategic input to individual clinical trial strategy and participate in strategy setting for clinical trial program.
  • Supervise and manage individuals on the US CDMA team as appropriate. Lead the Clinical Team, including interactions with Safety, HEOR, Marketing, Regulatory, Research, and other functions.
  • Work with Clinical Team and other functions to prepare abstracts, manuscripts and presentations for external meetings as well as author clinical sections of regulatory documents (i.e. IB, IND sections), for Company Sponsored project.
  • Review and approve abstracts publications & manuscripts for Investigator Initiated Trials to ensure clinical accuracy and appropriate safety review.
  • Present and discuss data and findings at relevant internal and external meetings.
  • Lead US cross functional Medical Product Teams and activities; Medical representative to the Brand team.
  • Support and participate in FDA meetings including presentations, briefing books, and responding to FDA inquiries as needed.
  • Extensive interactions with academic thought leaders to optimize clinical trial strategies.
  • Extensive interactions with other functional teams including HEOR, Medical Information, Scientific Communication, Commercial, Regulatory and others, to define compound strategy and projects.
  • Coach and train internal colleagues as requested.
  • Assist in the development and appropriate spending of clinical budget.
  • Ensure adherence to GCP/ICH and company Standard Operating Procedures (SOPs).

Experience and Qualifications: 

  • MD, board certified or board eligible in either internal Medicine, Endocrinology, Cardiology or relevant Medical Specialty preferred.
  • At least 5 years of experience in Diabetes clinical research in the pharmaceutical industry OR experience in clinical research or medical affairs is preferable or a combination of experience in academic medicine with clinical research and or clinical development experience in collaboration with the pharmaceutical industry. 
  • Scientific medical research experience in Cardiology, Diabetes or Metabolism with demonstrated record of scientific medical publications. Experience within diabetes therapeutic area highly preferred. 
  • Experience leading the design, conduct, analysis and reporting of clinical studies is strongly preferred.
  • Superior leadership, networking, collaboration and communication skills.  
  • Successful interactions with Medical Experts and investigators.
  • Demonstrated the capability for strategic planning along with operations skill and experience related to clinical research involving both single and multiple centers.
  • Ability to work across multiple functions is essential.  
  • Effective oral and written communications skills and strong leadership are essential for success in the role.

Please email CV 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

Chief Scientific Officer – Rare Disease Platform

We have a a a unique opportunity to join a well-funded startup looking at new platforms and technologies to treat rare and unmet neurodegenerative and neurological diseases – particularly in pediatric patients.

Academic advisory board consists of well-known industry giants and Nobel recipients.

 

For more insight, please contact tsharon@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. 

Head of Clinical Development – Immunotherapy and Biomarkers

  •  

    POSITION OVERVIEW

    The Vice President of Clinical Development will be responsible for establishing product requirements and development strategies for  Diagnostic Business Unit, while managing the execution of development plans for new and current products.  This important lead role will develop, plan and implement clinical research programs and trials. Lead the team to establish relevant product specification, evidence to support regulatory and payer requirements while addressing unmet clinical needs. The successful candidate will also present technology to key customers including clinical researchers, health care providers, and payers to gain engagement and support.  

    Vice President of Clinical Development will manage the allocation of personnel and financial resources to ensure the successful and timely completion of clinical product development goals.  This pivotal role will coordinate clinical product development with software development to effectively position clinical portfolio for long term success.  This hands-on leader will provide scientific expertise across the organization and drive cross-functional collaboration across all internal stakeholders while working closely with Medical Affairs. 

    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.  
    • Define and manage external partnership(s) including face to face meeting with global thought leaders
    • Interact with therapeutic partners to inform appropriate product requirements 
    • Serve as subject matter expert across the clinical portfolio to support business objectives
    • Expert communication of data in presentations at scientific conferences, either local, regional, or international
    • Create, support, present medical and scientific educational content supporting strategic plans
    • Exemplifies transparency and promotes quality of science
    • Liaise with Business Development and research functions to maximize the scope of new product development plans

    REQUIRED SKILLS, ABILITIES AND CREDENTIALS

    • Advanced degree in Life Sciences: PhD, MD, or MD PhD 
    • Strong technical background in molecular biology, genomics, next generation sequencing
    • >7 years of experience leading IVD and CLIA product development
    • Research experience in hematology, oncology or immunology with a demonstrated understanding of clinical trials addressing diagnosis, treatment of disease
    • Understanding of running clinical trials from study concept to publication
    • Excellent leadership experience in a matrix environment
    • Effective communication skills
    • Good interpersonal relationship building/maintenance
    • Ability to establish relationships and high-level customers
    • Strong presentation skills are very important
    • Excited about an early stage company environment that may require greater self-sufficiency.
    • Travel is required

please email CV to jobs@tseworldwide.com

 

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

Vice President, Personalized Medicine

We have multiple opportunities for Senior scientists to lead the next wave of cancer R&D for this client.

Ideal candidates have a PhD, have lead teams in product development and deep biomarker expertise.

To set up an exploratory, discussion, please email 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

Chief Medical Officer – Hematology / Oncology

Seeking a creative translational medicine expert to develop and execute the clinical research and development plan for the company. This key position with be responsible for evaluating the current Hematopoietic Stem Cell Transplantation landscape and building the translational science strategy for novel drug development programs. The successful candidate will identify and develop relationships with key opinion leaders, patient advocacy groups, academic institutes and hospitals to integrate novel advances in transplantation research into the drug development process and clinic.

Responsibilities/Requirements

  • Lead the clinical development strategy and be accountable for the execution of the translational medicine effort within the company
  • Collaborate closely with internal research team to integrate translational research into research, development and clinical strategies
  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators
  • Lead internal and external team members, vendors and consultants to develop an IND package, as well as review and evaluate pre-clinical safety data for submission
  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reports
  • Organize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetings
  • Support the business development process by providing medical expertise for in- or out-licensing, partnering and acquisition activities
  • Travel, as needed, nationally and internationally

Qualifications

  • Candidate must possess an MD with research experience or an MD / PhD, as well as a fellowship in Hematology/ Oncology or related areas
  • The ideal candidate will have several years of clinical experience in stem cell transplantation within academic medical, pharmaceutical and/or biotechnology sectors
  • Extensive experience in translational or clinical research related to drug development is required: biotech/ pharma experience favorably considered
  • Experience with developing regulatory strategy, including experience with IND-enabling, Phase I and Phase II studies preferred
  • Broad therapeutic area and target class expertise and experience in one of the following; Hematology/ Oncology, Auto-immunity and/ or Hematological Rare Genetic Diseases
  • Ability to identify and build relationships with thought leaders and leading clinical centers
  • Strong academic record with high quality peer-reviewed publications that demonstrate research productivity and the ability to perform cutting edge research in stem cell biology/transplantation and/or gene therapy
  • Effective communications (verbal & written) and presentation skills are essential

 

To apply, please submit your resume to jobs@tseworldwide.com