Director, Clinical Assay Development & Biomarkers

Role Summary

Director, Clinical Assay Development & Biomarkers. 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. Requires deep scientific expertise, operational leadership, and cross-functional collaboration to ensure biomarker-driven decisions enable effective drug development and personalized medicine strategies.

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.

Qualifications

• PhD in Molecular Biology, Immunology, Pharmacology, or related life sciences; MD or MD/PhD preferred.
• 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.

Skills

• Biomarker strategy and translational science
• Assay development (IHC, ELISA, PCR, NGS, flow cytometry, mass spectrometry)
• Clinical trial design and regulatory submissions (IND, NDA/MAA, CTA)
• Vendor and CRO management
• Data analysis and integration (biostatistics, bioinformatics)
• Cross-functional collaboration and leadership

Education

• PhD in Molecular Biology, Immunology, Pharmacology, or related life sciences; MD or MD/PhD preferred.

Additional Requirements

• Experience with regulatory filings and CDx development is preferred.
• Exposure to CLIA/CAP, GCLP, and IVD regulatory pathways.