Director of Assay Development and Biomarkers

Salary Range: 205000 to 246000 (Currency: USD) (Pay period: per-year-salary)

• Position Summary:  We are seeking an experienced and strategic Director, Assay Development and Biomarkers to lead and drive the development, validation, and implementation of biomarker strategies and associated assays across all stages of drug development—from early discovery through clinical development and into the post-marketing setting. This role requires deep scientific expertise, operational leadership, and cross-functional collaboration to ensure biomarker-driven decisions enable effective drug development and personalized medicine strategies.

Key Responsibilities:

• Develop and execute biomarker strategies aligned with program objectives across all development stages (preclinical, clinical, regulatory, and commercial).
• Define and prioritize biomarker hypotheses (PD, prognostic, predictive, safety, response) and guide integration into study designs.
• Provide expert input into translational and clinical development plans, including end-to-end biomarker plans for IND, CTA, and NDA/MAA submissions.
• Lead the development, optimization, and validation of robust, fit-for-purpose biomarker assays (e.g., IHC, ELISA, PCR, NGS, flow cytometry, mass spectrometry, multiplex platforms).
• Oversee internal or outsourced assay development and qualification for exploratory clinical trial use (CLIA/CAP, GCLP), and companion diagnostics (IVD).
• Ensure assay readiness and quality for use in clinical trials (e.g., sample logistics, CRO/vendor oversight, SOPs, assay tech transfer).
•  Partner with scientists, clinical teams, and regulatory leads to integrate biomarkers into clinical trial protocols and endpoints.
• Monitor biomarker data in ongoing studies; provide real-time interpretation to support clinical decisions.
• Collaborate with biostatistics, bioinformatics, and data science teams for analysis, interpretation, and visualization of biomarker data.
• Drive partnerships with discovery, clinical, regulatory, commercial, and CDx development functions to ensure continuity and alignment.
• Manage external vendors, CROs, and diagnostic partners; serve as technical and scientific lead in biomarker-related interactions.
• Represent biomarker strategy at governance meetings, scientific advisory boards, and regulatory interactions as needed.
• Support regulatory filings (e.g., INDs, NDAs, CTDs) with biomarker and assay content, including responses to health authority questions.
• Develop biomarker plans for post-marketing commitments, real-world evidence generation, or CDx lifecycle management.

Required Qualifications:

• MS or PhD in Molecular Biology, Immunology, Pharmacology, or related life sciences discipline.
• Therapeutic area experience in Liver Diseases, Neurological Disorders, or Rare Diseases.
• 10+ years of experience in biomarker research, translational science, or assay development within the biotech/pharma industry.
• Proven experience with biomarker strategy and assay development across discovery, clinical, and commercial stages.
• Demonstrated success working with regulatory agencies on biomarker and CDx-related filings.
• Experience managing CROs and external diagnostic partners.
• Deep knowledge of a broad range of assay platforms and technologies.
• Familiarity with GLP/GCLP, CLIA, and regulatory requirements for biomarker assays.
• Strong understanding of genomics, proteomics, and data integration.
• Proven leadership in cross-functional matrix environments.
• Excellent written and verbal communication skills, including scientific presentation and regulatory writing experience.
• Strategic thinker with operational excellence and scientific rigor.