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.
Top Skills
What We Do
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
For additional information on our guidelines, please visit https://scholarrock.com/community-guidelines/
For more information on how Scholar Rock collects, uses, and shares personal information, please visit: https://scholarrock.com/privacy-policy
