General Summary:
- Develop and implement the clinical biomarker strategy and biomarker plan with minimal guidance. Provide expert oversight in biomarker assay development and validation, working with internal teams and external CROs to ensure fit-for-purpose validation. Serve as a specialized technical expert (e.g., CDx, immunoassays, genomic assays, flow assays), leading complex problem-solving and communicating difficult concepts.
Key Duties And Responsibilities:
- Develop and align biomarker strategy cross-functionally.
- Oversee development, validation, and implementation of fit-for-purpose biomarker assays for clinical-phase programs.
- Serve as key point of contact for internal/external stakeholders on assay design requirements (patient selection, target engagement, PD and MoA biomarkers).
- Collaborate in a matrixed environment to develop and validate assays across matrix and tissue types.
- Oversee assay activities at external vendors; recommend requirements for GCLP assay development and use.
- Ensure assays are developed/validated per regulatory guidance and ready for clinical use; provide supportive written assay documentation.
- Build relationships with diagnostics vendors and CROs using internal/external assays.
- Lead biomarker deliverables; present data/strategy to cross-functional teams and senior management.
- Represent the company at external meetings/conferences.
- Contribute to work streams and build biomarker capabilities.
Knowledge, Skills, Education, Experience:
- Specialized depth/breadth in biomarker development and validation; impacts program objectives.
- Communicates and persuades; manages multiple tasks; excellent interpersonal/communication skills; innovative decision-making.
- PhD (or equivalent) + 6β8 years; or Masterβs + 9+ years; or Bachelorβs + 11+ years in relevant field.
Compensation/Work Arrangement:
- Pay Range: $160,000β$240,000; eligible for annual bonus and annual equity awards.
- Benefits (explicitly mentioned): medical/dental/vision, paid time off (week-long summer and winter shutdown), educational assistance/student loan repayment, commuting subsidy, matching charitable donations, 401(k).
- Flex: Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility).