Head of Biomarker Development

Strategic Leadership & Vision

• Define and drive the biomarker development strategy across preclinical and clinical programs, ensuring alignment with overall portfolio goals.
• Serve as a translational science thought leader, integrating biomarker approaches into program strategy, clinical development plans, and indication expansion activities.
• Represent Biomarker Development in cross-functional governance and portfolio planning forums.

Functional & Scientific Oversight

• Lead the design, development, and qualification of fit-for-purpose biomarker assays (fluid, tissue, imaging, molecular, and cellular).
• Oversee biomarker implementation in preclinical models and clinical studies, ensuring robust data generation and interpretation.
• Manage CROs and external collaborators/vendors to deliver high-quality biomarker data.
• Collaborate with discovery teams to translate preclinical biomarker hypotheses into clinically actionable endpoints.
• Provide expertise on novel technologies (e.g., immunoassays, LC-MS, SIMOA, RNA-seq, digital pathology, imaging biomarkers, multiparameter flow cytometry).

Regulatory & Clinical Integration

• Contribute to the design of biomarker plans within clinical study protocols, informed consent forms, and statistical analysis plans.
• Author and review biomarker sections of INDs, CTAs, IBs, CSRs, and other regulatory filings.
• Present biomarker data and strategy to internal stakeholders, governance committees, external partners, and regulatory agencies.

Candidate Requirements:

• PhD in biology, immunology, neuroscience, pharmacology, or related discipline.
• 10+ years of experience in biotech/pharma R&D with a strong track record in biomarker discovery and development, including translational application in clinical trials.
• Demonstrated leadership in developing and implementing biomarker strategies for rare diseases; experience in neuromuscular disorders strongly preferred.
• Proven expertise with a range of biomarker platforms (immunoassays, LC-MS, transcriptomics, imaging, flow cytometry, digital pathology, and molecular assays).
• Familiarity with bioanalytical and regulatory requirements for biomarker integration in IND-enabling studies and clinical development.
• Experience managing CROs, external consultants, and collaborative teams.
• Strong leadership, interpersonal, and communication skills, with the ability to influence across levels and functions.
• Passion for rare disease research and a commitment to improving patients’ lives.