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Director, Clinical Development

  • Seaport Blvd., Boston, Massachusetts, United States
  • Full Time

ABOUT THE JOB:

The Director, Clinical Development partners the multifaceted Clinical Development Team, the Medical Affairs Team, Data Scientists, groups on patient engagement and with other professionals to execute upon the strategy and operating plan of the department. In this position the incumbent is responsible for ensuring that operations serve the objectives of FMI and are moving towards established goals.

Key Responsibilities:

  • Assist in defining F1LCdx product profile and initiate the key studies to support the product’s adoption and reimbursement.
  • Partner internally with colleagues to develop the clinical studies that continue to build value in Foundation One CDxR.
  • 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 to gather outcomes data on our tests for demonstration of clinical validity of our tests and the benefits for payers.
  • Execute upon efforts designed to build value into our new products and tests.
  • Collaborate closely with the Data Team to build the capabilities of the Foundation Medicine Flatiron Health clinicogenomic database (CGDB), which contains 40,000+ genomic profiles paired with longitudinal clinical annotations (including treatments, response, and survival).
  • Design and conduct innovative clinical trials, increase the actionability of molecular information, and speed new therapeutic development.
  • Work with teams across Foundation Medicine to improve clinical decision-making tools and to support the translation of molecular information to actionable knowledge.
  • Periodically serve as a representative of FMI itself in larger business settings.
  • Other duties as assigned.

QUALIFICATIONS:
Basic Qualifications:

  • Medical Doctor or Doctor of Philosophy, Board-eligible for Hematology and Oncology.

Preferred Qualifications:

  • Experience in developing and executing clinical trials in the biopharmaceutical industry, including protocol development and design.
  • Prior experience in planning and executing clinical trials for biomarker-driven cancer therapies and/or immuno-oncology trials.
  • Strong previous clinical and academic record in medical oncology at a leading academic medical center.
  • Strong academic record of conducting retrospective clinical research.
  • Ability to analyze and interpret clinical and efficacy data and develop written reports and presentations of those data.
  • Demonstrated excellence in active listening and other interpersonal skills to include written, oral, presentation and collaboration.
  • Ability to communicate complex messages with both physician and lay audiences.
  • Understanding of HIPAA and importance of privacy of patient data.
  • Excellent organization and attention to detail.
  • A “can do” attitude as demonstrated by a history of success within a fast-paced, high accountability environment.
  • Excellent listening and interpersonal skills with ability to collaborate with multiple functions in a team environment.

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Internal applicants, please use your FMI email address.

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