Zenas BioPharma
Senior Director, Biomarker Development, Strategy and Operations
Waltham, MA · Director
Sponsorship not specified$227k-$284kDetected 26 days ago
StatisticsBusiness DevelopmentBudgetingLogisticsCompensationClinical TrialsBioinformaticsFlow CytometryMolecular BiologyExperimental DesignAnimal StudiesLeadershipCommunicationMentoring
About the role
- 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.
- 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.
Responsibilities
- Define and lead a portfolio-wide biomarker strategy aligned with program goals, clinical endpoints, and regulatory pathways
- 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
- Lead assay strategy across modalities (e.g., flow cytometry, genomics, proteomics)
- Own end-to-end biomarker operations across clinical studies, including vendor selection and oversight (CROs, central labs, diagnostics partners)
- 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
- Identify, select, and manage external collaborators (CROs, diagnostic companies, academic institutions)
- Support business development through scientific due diligence and biomarker strategy evaluation
Requirements
- Ph.D. in Immunology, Molecular Biology, Translational Medicine, or related field (or equivalent experience), or MS degree with 12+ years relevant industry experience.
- 8+ years of biotech/pharma experience, including biomarker or translational leadership roles
- Deep expertise in biomarker strategy and translational science, assay development and validation, and clinical biomarker implementatio
- 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
- 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
- Motivated and curious with a demonstrated ability to work in multidisciplinary teams in a fast-paced, entrepreneurial, and technical setting
- Demonstrated success supporting both early and late-stage clinical development programs
- Strong operational leadership managing vendors, budgets, and timelines
- Goal-oriented, organized, capable of prioritizing and working on multiple projects, and able to execute to timelines that meet company goals
- Flexibility to work non-traditional work hours when needed, given international operations across time zones
Compensation
- The position is eligible for a competitive compensation and benefits package.
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