About the Job:

The Sr Director, Clinical Trials, Clinical Development is a senior, highly visible and cross-functional leadership role within the Foundation Medicine (FMI) Clinical Development team, partnering closely with various teams across the company. It is designed for a biopharma drug developer leader with deep experience across first-in-human (FIH) through Phase 3 clinical trials.This position partners with internal and external collaborators to design, execute, and interpret precision medicine-enabled clinical trials that integrate FMIs genomic profiling into therapeutics development programs.

The ideal candidate is an experienced physician (M.D.) with a strong track record in oncology drug development, clinical protocol authorship, and endtoend execution of global interventional studies. This leader will ensure that FMI assays are optimally incorporated into internal evidence programs defined in the Clinical Development Plans (CDPs), and into biopharma or academic (AMC)-sponsored trials in order to generate data that support clinical development, regulatory and reimbursement strategy, and downstream clinical adoption.

Key Responsibilities:

Provide strategic and scientific leadership for clinical trial design and execution across FIH, Phase 1, Phase 2, and Phase 3 oncology programs incorporating precision medicine approaches to support CDPs and product strategy.
Lead or co-lead the design, authoring and review of clinical protocols, including biomarker strategies, statistical consideration and operational feasibility.
Serve as a senior clinical development partner to biopharma or AMC collaborators, advising on optimal use of FMI assays within therapeutic development programs.
If appropriate, oversee execution of interventional and observational studies, ensuring high-quality delivery, data integrity, and adherence to GCP and regulatory standards
Provide expert clinical input into the translational research to develop insights into predictive and prognostic biomarkers, to further the development of our products and strategy.
Partner with Clinical Development Plan Leads and scientists to guide and support the CDP execution, including the planning and delivery of impactful evidence generation activities. Working closely with Product, R&D, Clinical Commercial, Biopharma, Biostatistics, Clinical Operations, Payers, Medical Affairs, and other functions to ensure alignment and successful product development throughout the life cycle management.
Demonstrate Medical leadership, including on Department initiatives (and/or Evidence Generation Working Groups), Business teams, Working groups and Product strategy. Can conceptualize/identify projects and prioritize in the context of FMI business interests, ensuring studies advance the strategic priorities of FMI portfolio.
Apply extensive theoretical and cross-functional expertise, including outside of own discipline, in the context of company objectives to independently address complex problems with regular use of ingenuity and innovation.
Establish and maintain strong relationships with key opinion leaders, academic investigators, and biopharma partners.
Contribute to scientific publications, abstracts, regulatory and reimbursement documents, and external-facing materials.
Maintain availability to the wider FMI business for clinical development expertise, presenting information to scientific, medical, or nonprofessional stakeholders.
Other duties pertinent to clinical / translational science as assigned.

Basic Qualifications:

• M.D. with 10+ years of industry experience or equivalent in oncology or hematology field or equivalent combination of training and experience

Preferred Qualifications:

• Board-certified or board-eligible medical oncologist.
• Extensive experience in:
  • Designing and executing Phase 13 interventional clinical trials
  • Clinical protocol writing and review (including biomarker-driven designs)
  • Precision medicine and molecularly selected patient populations
• Prior experience working closely with or within biopharmaceutical organizations.
• Strong understanding of regulatory and reimbursement expectations for clinical development and diagnostics used in therapeutic trials.
• Demonstrated excellence in scientific and medical writing (protocols, publications, regulatory-facing documents).
• Proven ability to lead complex, cross-functional initiatives in a fast-paced environment.
• Demonstrated ability to lead cross-functional teams, collaborate effectively and communicate clearly with various stakeholders
• Experience communicating with treating physicians and other external stakeholders
• Ability to work independently as well as collaborate and communicate effectively with cross-functional teams
• Strong interpersonal skills that include excellent skills in written communication, oral communication, collaboration, and problem solving with other departments and colleagues
• Excellent organizational skills and meticulous attention to detail
• Extremely high level of integrity and reliability
• Willingness to adhere to all applicable FMI Standard Operating Procedures, policies, processes, and compliance guidelines
• Agreement to maintain confidentiality regarding sensitive company, employee, and proprietary data and information
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Boston, MA is $275,000 - $327,000 per year. The salary range is commensurate with Foundation Medicine's compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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