Senior Director, Biomarker Development, Strategy and Operations
About The Position
The Senior Director, Biomarker Development, Strategy, and Operations is a strategic and operational leader responsible for defining and executing an integrated biomarker vision across the portfolio. This role drives end-to-end biomarker strategy, assay development, translational science, and operational execution from early through late-stage clinical development. The individual will serve as a key enterprise leader, ensuring biomarkers inform critical decisions across the portfolio, enabling precision medicine approaches and maximizing the value of therapeutic programs. This role is highly cross-functional, requiring close partnership with Clinical Development, Translational Sciences, Clinical Operations, Regulatory, Medical Affairs, and Commercial teams, and leadership of external collaborations.
Requirements
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or equivalent experience), or MS degree with 15+ years relevant industry experience.
- 8+ years of biotech/pharma experience, including biomarker or translational leadership roles
- Demonstrated success supporting both early and late-stage clinical development programs
- Deep expertise in biomarker strategy and translational science, assay development and validation, and clinical biomarker implementation
- Proven people leadership experience, including direct supervision, mentoring, and development of high-performing translational or biomarker teams
- Strong understanding of autoimmune/inflammatory disease biology
- Experience integrating biomarker data into regulatory submissions
- Strong operational leadership managing vendors, budgets, and timelines
- Excellent communication and presentation skills, ability to translate complex data into actionable strategic insights in a clear and thorough manner for both verbal and written context
- Goal-oriented, organized, capable of prioritizing and working on multiple projects, and able to execute to timelines that meet company goals
- Motivated and curious with a demonstrated ability to work in multidisciplinary teams in a fast-paced, entrepreneurial, and technical setting
- Flexibility to work non-traditional work hours when needed, given international operations across time zones
Responsibilities
- Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways
- Establish biomarker frameworks spanning target engagement, PK/PD, and mechanism-of-action, disease biology, predictive, prognostic, and pharmacodynamic biomarkers
- Integrate preclinical, clinical, and emerging real-world data to drive indication selection and patient enrichment strategies
- Ensure biomarker strategies support differentiation, value demonstration, and lifecycle management of assets
- Serve as biomarker SME on cross-functional program teams, shaping study design and endpoint selection
- Oversee the development, qualification, validation, and lifecycle management of fit-for-purpose biomarker assays (exploratory through regulatory-grade)
- Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics)
- Ensure scientific rigor, reproducibility, and compliance across all biomarker platforms
- Own end-to-end biomarker operations across clinical studies, including vendor selection and oversight (CROs, central labs, diagnostics partners); budgeting, timelines, and risk management; sample flow logistics and assay execution
- Lead outsourcing strategy including assay transfer, validation, and execution at external partners
- Ensure high-quality, timely data delivery, including rigorous QC and data review
- Guide incorporation of biomarkers into clinical protocols, statistical analysis plans, and regulatory documentation (IND/CTA/BLA/NDA)
- Identify, select, and manage external collaborators (CROs, diagnostic companies, academic institutions)
- Serve as external-facing scientific leader in biomarker strategy and translational medicine
- Support business development through scientific due diligence and biomarker strategy evaluation
- Contribute to scientific publications, conferences, and regulatory interactions
Benefits
- competitive compensation and benefits package
- annual performance bonus
- equity
- full range of benefits
- other incentive compensation plans
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
