The Research and Development team at Foundation Medicine is constantly pushing the envelope to transform cancer care.
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About the Job
The Senior Director, Biomarker Development and Biometrics oversees the department which partners closely with the cross-functional product lifecycle teams, Clinical Development and Cancer Genomics, and is a member of Foundation Medicine’s R&D leadership team. This role provides an opportunity to engage in a cross-functional partnership to enable best-in-class precision medicine CDx assays, using strong leadership and organizational skills. The Senior Director is accountable for ensuring team collaboration with Regulatory Affairs, CDx Development Operations and Biopharma to design verification and validation studies and perform V&V data analysis for new diagnostic biomarkers, Investigational Use biomarkers and software systems associated with biomarker reporting. This position is also responsible for collaborating with Research and Early Development (RED) and Assay Development for design and development of feasibility and, development studies. Upon completion of the development stage, this role continues to provide oversight for study design support for V&V studies in collaboration with the product life-cycle team to ensure that assay design is fit for purpose. The incumbent is deeply involved in companion diagnostic indication expansion, supports research and development of both new assays as well as biomarkers from existing platforms, and ensures robust performance of Foundation Medicine assays.
Hybrid work at a designated FMI location is an essential function of this role.
• Manage and lead the Biomarker Development and Biometrics Team’s daily deliverables and workflow.
• Mentor and support ongoing professional development and growth of the team.
• Ensure team efforts to improve the consistency, accuracy and robustness of biomarker rules continue
• Ensure that the team is represented on the Biomarker Subject Matter Expert Working Group and Biomarker Development Subteam as key leader in both efforts.
• Be accountable for management of biomarker rules.
• Ensure support of Pharma partnering work:
• Ensure Statistical Analysis Plans (SAPs) are authored and reviewed by appropriately trained personnel.
• Provide key contributions to the analytical and clinical validation studies in the program, including, but not limited to, study protocol development, testing and execution for regulatory submissions.
• Collaborate cross-functionally to support development and optimization of biomarkers.
• Contribute to the planning and delivery of key analytical components of regulatory submissions, including, but not limited to, Q-subs, PMA, and sPMA.
• Contribute to the long-term growth strategy of Product Development.
• Lead the design and analysis of novel NGS-based biomarker for precision medicine.
• Proactively raise issues and propose solutions.
• Other duties as assigned.
• Master’s Degree in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field and 12+ years of experience in a laboratory setting in the life sciences industry and/or academia; OR,
• Ph.D. in Molecular Biology, Biochemistry, Genetics, Cancer Genomics, or related field and 10+ years of experience in a laboratory setting in the life sciences industry and/or academia
• Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field
• 12+ years of working experience in in the life sciences industry and/or academia in a laboratory setting
• Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment
• Prior experience managing a team of scientists of all levels
• Experience developing biomarkers using NGS data
• Experience writing code
• Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one’s own workflow
• Demonstrated track record of timely completion ahead of deadlines
• Demonstrated ability to work in a dynamic fast paced team environment
• Statistical and computational knowledge
• Ability to work well under pressure while maintaining a professional demeanor
• Excellent organizational skills and attention to detail
• Strong interpersonal skills that include excellent skills in collaboration and problem solving with other departments and colleagues
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion
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)
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