The Director, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine (FMI) Liquid Franchise team, partnering closely with various teams across the company. This position manages scientific collaborations with key opinion leaders in clinical oncology and leverages prospective and real-world clinical datasets with the goal of driving studies, establishing the utility of genomic profiling and supporting the overall product strategy.
Key Responsibilities
Assist in defining FoundationOne Liquid CDx (F1LCDx) product profile and initiate the key studies to support the product's adoption.
Partner internally with colleagues to develop the clinical studies that continue to build value in F1LCDx.
Collaborate closely with the Medical, Data, and Research & Development Teams in supporting FMI's publications and in assessment of new technologies.
Design and conduct clinical trials leveraging innovative diagnostic applications.
Contribute to protocol design and review for studies led by Clinical Development.
Lead key manuscripts from initial concept to publication to establish clinical validity and clinical utility of our products.
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.
Ensure studies advance the strategic priorities of FMI products.
Contribute broadly to the conception and execution of conference abstracts and publications.
Manage and establish beneficial collaborations with key opinion leaders in oncology.
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., Ph.D., or Doctorate Degree in a life science, board-eligible for Hematology and Oncology.
10+ years of experience in clinical research and genomics in an academic or life sciences industry setting
Preferred Qualifications
Prior experience in planning and executing clinical trials for biomarker-driven cancer therapies and/or immuno-oncology trials
Demonstrated experience in the field of genomics
Experience with clinical study design and clinical protocol drafting
Experience with biomedical data analysis (genomics data, clinical outcomes, blood biomarkers i.e. circulating tumor DNA)
Experience communicating with treating physicians
Strong previous clinical and academic record in medical oncology at a leading academic medical center
Strong academic record of conducting retrospective clinical research
Demonstrated ability to successfully manage multiple concurrent projects in a fast-paced, dynamic environment
Expertise in clinical research linking genomic biomarkers with clinical outcomes
Strong track record of taking projects from concept to completion
Lead-authored publications, and demonstrated excellence in writing
Familiarity with analyzing blood biomarkers such as circulating tumor DNA to support innovative diagnostic applications.
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
Understanding of HIPAA and the importance of patient data privacy
Commitment to FMI's values: passion, patients, collaboration, and innovation
Foundation Medicine, Inc. (FMI) began with an idea - to simplify the complex nature of cancer genomics, bringing cutting-edge science and technology to everyday cancer care. Our approach generates insights that help doctors match patients to more treatment options and helps accelerate the development of new therapies. Foundation Medicine is the culmination of talented people coming together to realize an important vision, and the work we do every day impacts real lives.
Foundation Medicine is proud to be an Equal Opportunity and Affirmative Action employer and considers all qualified applicants for employment without regard to race, color, religion, sex, gender, sexual orientation, gender identity, ancestry, age, or national origin. Further, qualified applicants will not be discriminated against on the basis of disability or protected veteran status. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements. See also FMI's EEO Statement and EEO is the Law and Supplement . If you have a disability or special need that requires accommodation, please let us know by completing this form . (EOE/AAP Employer)
