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About the Job
The Director, Clinical Development is a highly visible and cross-functional leadership role on the Foundation Medicine (FMI) Clinical Development team. This individual will serve as Clinical Lead for critical products within the portfolio and will lead the implementation of a strategic Clinical Development Plan, partnering closely with various teams across the company. Leveraging a base of diagnostic expertise and clinical insights, this position manage scientific collaborations with clinical investigators and leverages prospective and real-world clinical datasets to drive studies, establish the utility of genomic profiling and execute on FMI’s product strategy.
• Serve as the Clinical Development Lead for key products within the FMI portfolio
• Execute on a strategic Clinical Development Plan including prospective clinical studies, collaborative investigations, and real-world data analyses.
• Partner internally and externally with colleagues to develop the clinical studies that continue to build product value.
• Design and conduct clinical trials leveraging innovative diagnostic applications, including protocol design and review.
• Leverage FMI’s clinical and genomic datasets to link genomic findings with clinical outcomes.
• Lead key manuscripts from initial concept to publication to establish clinical validity and clinical utility of our products.
• Assist in defining target product profile and initiating the key studies to support product adoption.
• Proactively develop biopharma relationships that strategically advance the development needs of the product.
• Collaborate cross-functionally to identify and prioritize key clinical studies that support use, access, and reimbursement.
• 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.
• 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
• 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 complementary analytes including RNA and protein expression
• 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
Please be aware that Foundation Medicine mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.
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.
Confidence, or the belief that we need to check every box before applying for a job, can sometimes hold us back from going after a role that inspires us. At Foundation Medicine there's no such thing as the 'perfect' applicant, and our company is a place where every employee can make an impact and continue to grow whatever background they may have or path they may have taken. So, as long as you meet the basic qualifications for a role, please apply if you see a position that would make you excited to come into Foundation Medicine every day and help us transform cancer care.
Internal applicants, please use your FMI email address.
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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)
To all recruitment agencies: Foundation Medicine does not accept agency resumes. Please do not forward resumes to our jobs alias, Foundation Medicine employees or any other organization location. Foundation Medicine is not responsible for any fees related to unsolicited resumes.
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