Senior Director, Biomarkers and Biometrics at Foundation Medicine in Cambridge, MA
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. Key Responsibilities o Manage and lead the Biomarker Development and Biometrics Team's daily deliverables and workflow. o Mentor and support ongoing professional development and growth of the team. o Ensure team efforts to improve the consistency, accuracy and robustness of biomarker rules continue o Ensure that the team is represented on the Biomarker Subject Matter Expert Working Group and Biomarker Development Subteam as key leader in both efforts. o Be accountable for management of biomarker rules. o Ensure support of Pharma partnering work:
Attend partner meetings to gather biomarker requirements and communicate rules/technical details to partner; Perform gap-analysis to determine required development work; Function as subject matter expert on basic analysis pipeline, curation and biomarker discussions; Develop and recommend statistical analysis strategy for required studies. o Ensure Statistical Analysis Plans (SAPs) are authored and reviewed by appropriately trained personnel. o 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. o Collaborate cross-functionally to support development and optimization of biomarkers. o Contribute to the planning and delivery of key analytical components of regulatory submissions, including, but not limited to, Q-subs, PMA, and sPMA. o Contribute to the long-term growth strategy of Product Development. o Lead the design and analysis of novel NGS-based biomarker for precision medicine. o Proactively raise issues and propose solutions. o Other duties as assigned. Qualifications Basic Qualifications o 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, o 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 Preferred Qualifications o Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field o 12
years of working experience in in the life sciences industry and/or academia in a laboratory setting o Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment o Prior experience managing a team of scientists of all levels o Experience developing biomarkers using NGS data o Experience writing code o Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow o Demonstrated track record of timely completion ahead of deadlines o Demonstrated ability to work in a dynamic fast paced team environment o Statistical and computational knowledge o Ability to work well under pressure while maintaining a professional demeanor o Excellent organizational skills and attention to detail o Strong interpersonal skills that include excellent skills in collaboration and problem solving with other departments and colleagues o Understanding of HIPAA and importance of privacy of patient data o 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.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Attend partner meetings to gather biomarker requirements and communicate rules/technical details to partner; Perform gap-analysis to determine required development work; Function as subject matter expert on basic analysis pipeline, curation and biomarker discussions; Develop and recommend statistical analysis strategy for required studies. o Ensure Statistical Analysis Plans (SAPs) are authored and reviewed by appropriately trained personnel. o 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. o Collaborate cross-functionally to support development and optimization of biomarkers. o Contribute to the planning and delivery of key analytical components of regulatory submissions, including, but not limited to, Q-subs, PMA, and sPMA. o Contribute to the long-term growth strategy of Product Development. o Lead the design and analysis of novel NGS-based biomarker for precision medicine. o Proactively raise issues and propose solutions. o Other duties as assigned. Qualifications Basic Qualifications o 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, o 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 Preferred Qualifications o Ph.D. in Molecular Biology, Biochemistry, Genetics or Cancer Genetics, or related field o 12
years of working experience in in the life sciences industry and/or academia in a laboratory setting o Extensive experience with molecular biology techniques and an understanding of the practices and principals of NGS, including DNA-seq and target-enrichment o Prior experience managing a team of scientists of all levels o Experience developing biomarkers using NGS data o Experience writing code o Demonstrated history of successfully managing multiple concurrent initiatives and maintaining one's own workflow o Demonstrated track record of timely completion ahead of deadlines o Demonstrated ability to work in a dynamic fast paced team environment o Statistical and computational knowledge o Ability to work well under pressure while maintaining a professional demeanor o Excellent organizational skills and attention to detail o Strong interpersonal skills that include excellent skills in collaboration and problem solving with other departments and colleagues o Understanding of HIPAA and importance of privacy of patient data o 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.
Salary Range:
$200K -- $250K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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