The Head of Biomarker Development will drive biomarker strategy for clinical programs, oversee assay development, and ensure translation from discovery to clinical phases at Scholar Rock.
Scholar Rock is a late-stage global biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe, and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the Company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin program, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Summary of Position:
Scholar Rock is seeking a strategic and accomplished scientific leader to serve as Head of Biomarker Development. This individual will be 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. Reporting to the Vice President, Head of Preclinical Sciences, this leader will design and implement fit-for-purpose biomarker approaches, oversee assay development and data generation, and serve as a key contributor to regulatory submissions, clinical protocols, and program strategy. This individual will be a member of the research leadership team.
The successful candidate will integrate discovery, translational, and clinical perspectives to ensure biomarker strategies inform patient selection, target engagement, pharmacodynamics, and disease progression across stages of development.
Position Responsibilities:
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.
Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Scholar Rock Cambridge, Massachusetts, USA Office
301 Binney St, , Cambridge, Massachusetts , United States, 02142
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