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Sr Dir, Biomarkers

  • Cambridge, Massachusetts, United States
  • Full Time

About the Job

Foundation Medicine is looking for a Senior Director to lead critical scientific and biomarker analysis/development efforts, reporting to VP, Head of Biometrics and Biomarkers. The position will lead and manage a multidisciplinary team of 10- 15 members who are responsible for biomarker design, definition/rule, and analysis, developing and implementing long term biomarker strategy. Team is also responsible for analytical study protocol writing, testing, and execution. The successful candidate will be highly collaborative, able to work broadly across the organization and cross-functionally with internal stakeholders and with external biopharma partners. The individual in this role will need to have a strong understanding of computational biology and bioinformatics, excellent communication and interpersonal skills, strong leadership and management skills, strong tactical thinking, and the ability to navigate the organizational culture and teams at FMI. The ability to work in a dynamic, fast-paced environment will be critical to success.

The Senior Director, Biomarkers is responsible for supporting the biomarker team function and its activities, the development of biomarker strategy, accountable for management of biomarker rules, supporting development/optimization of Biomarkers, contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. FMI’s products include diagnostic assays that provide molecular insights to physicians to guide treatment options for cancer patients. The incumbent functions as the biomarker representative on cross-functional teams. The incumbent will actively support the development of biomarker strategy focused on the use of NGS technology for companion diagnostic assays for cancer patients. This position partners closely with product development teams and external partners focused on development of genomic biomarkers and companion diagnostic indications.

 

Key Responsibilities

• Manage and lead the Biomarker Team’s daily deliverables and workflow.

• Lead and mentor Biomarker team personnel while supporting their ongoing professional development and growth

• Lead efforts to improve the consistency on how biomarker rules are defined and formatted including

·   Define process to intake/organize new biomarkers and manage process moving forward

·   Provide biomarker definitions and rules

·   Work with other functional teams to implement new biomarkers in pipeline

·   Gather biomarker requirements from partners and perform gap analysis supported by the other functional teams

·   Maintain an accounting of all biomarker rules (definition, partner/program, description of implementation)

·   Solicit feedback and communicate biomarker definition/rule and biomarker analysis results within FMI and to external stakeholders

·   Develop, coordinate and implement long term biomarker strategy

• Accountable for management of biomarker rules

·   Propose definition and obtain feedback from relevant functional groups

·   Manage regularly scheduled cross-functional meetings to ensure that development work is completed on time as needed and that biomarker rules are correctly integrated for biomarker reporting

• Support Pharma partnering work:

·   Attend partner meetings to gather biomarker requirements and communicate rules/technical details to partner

·   Perform gap-analysis to determine if development work is required

·   Function as subject matter expert on basic analysis pipeline, curation and biomarker discussions.

• 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

• Support Development/Optimization of Biomarkers

 

Qualifications

Basic Qualifications

• Master’s Degree in Computational Biology, Bioinformatics, Biochemistry, Molecular Biology, Biochemistry, Genetics, Cancer Genomics or a related field with a significant quantitative base

• At least 6 years in the biotechnology or diagnostics industry, 3 of which must include management of direct reports

• Exquisite attention to detail and an obsession with quality

• Demonstrated leadership skills such as strategic thinking, ability to prioritize, and effective cross-functional partnering

 

Preferred Qualifications

• Doctor of Philosophy in Computational Biology, Bioinformatics, Biochemistry, Molecular Biology, Biochemistry, or a related field with a significant quantitative base

• 8+ years of experience in the biotechnology industry and diagnostics industry experience

• Extensive knowledge of predictive biomarkers for cancer therapy

• Extensive scientific understanding of cancer genetics and genomics

• Knowledge and experience with Next-Generation Sequencing (NGS).

• Experience with bioinformatics tools and databases (e.g., NCBI, UCSC Genome Browser, IGV)

• Strong programming skills, technical proficiency and creativity

• Excellent communication, presentations and writing skills, and the ability to explain complex technical details in clear language

• Polished and professional presentation skills

• Demonstrated record of leading team projects to success

• Experience with cluster parallel computing is preferred

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