Head of Biomarker Development

Role Summary

Head of Biomarker Development responsible for shaping and executing the biomarker strategy across Scholar Rock’s pipeline to enable translation from discovery through clinical development in neuromuscular and rare diseases. Design and implement fit-for-purpose biomarker approaches, oversee assay development and data generation, and contribute to regulatory submissions, clinical protocols, and program strategy. Member of the research leadership team, integrating discovery, translational, and clinical perspectives to inform patient selection, target engagement, pharmacodynamics, and disease progression across development stages.

Responsibilities

• 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.
• 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).
• 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.

Qualifications

• 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‚Äô lives.

Skills

• Translational biomarker strategy
• Assay development and qualification
• Data generation, interpretation, and integration
• Regulatory writing and regulatory filings
• Project and vendor management
• Cross-functional leadership and collaboration
• Advanced technologies (immunoassays, LC-MS, SIMOA, RNA-seq, digital pathology, imaging, flow cytometry)

Education

• PhD in biology, immunology, neuroscience, pharmacology, or related discipline

Additional Requirements

• Experience with biomarker integration in IND-enabling studies and clinical development