About the Job

The Sr Director, Clinical Trials, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine (FMI) Clinical Development team, partnering closely with various teams across the company. This position leads the clinical evidence strategy, planning and execution of scientific collaborations or clinical trials with key opinion leaders and leverages prospective and real-world clinical datasets with the goal of driving evidence activities to support the product development throughout the life cycle management, establishing the clinical validity and utility of genomic profiling, ensuring alignment with overall business goals. 

Key Responsibilities

• Accountable and lead of the development of Clinical Development Plans (CDP) for diagnostic assays, including clinical validation and utility studies supporting the analytical validity of the product as well as post-launch data.
• Lead of the development and execution of other Department initiatives and /or Evidence Generation Working Groups.
• Working closing with Product, R&D, Commercial, Biopharma, 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, 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.
• Partner with scientists to guide and support the planning and delivery of impactful evidence generation activities. 
• Overseeing the design, execution and monitoring clinical trials leveraging innovative diagnostic applications.
• Conduct translational research to develop insights into predictive and prognostic biomarkers.
• Leverage FMI’s clinical and genomic datasets to link genomic findings with clinical outcomes.
• Collaborate cross-functionally to identify and prioritize key clinical studies that support use, access, and reimbursement.
• Manage and establish beneficial and new collaborations with key opinion leaders and external collaborators.
• Serving as a subject matter expert on clinical aspects and molecular diagnostics. Continually develop deep domain expertise in genomics from a scientific, clinical and technical standpoint and lend insights to cross-functional teams to further the development of our products and strategy.
• 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.

Qualifications:

Basic Qualifications:

• M.D. or Ph.D. with 12+ years of industry experience or equivalent in oncology or hematology field or 
• Master’s degree in related field and 15+ years of work experience

Preferred Qualifications:

• Prior experience in planning and executing clinical trials for biomarker-driven cancer therapies and/or immuno-oncology trials
• Experience with clinical study design and clinical protocol drafting 
• Demonstrated experience in the field of genomics
• Demonstrated experience in drug development
• Experience with biomedical data analysis (genomics data, clinical outcomes, blood biomarkers i.e. circulating tumor DNA)
• Demonstrated ability to lead cross-functional teams, collaborate effectively and communicate clearly with various stakeholders
• Experience communicating with treating physicians 
• Demonstrated ability to successfully manage multiple concurrent projects in a fast-paced, dynamic environment
• Strong track record of taking projects from concept to completion
• Demonstrated excellence in scientific writing
• 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 FMI’s values: Integrity, Courage, and Passion 

#LI-Hybrid