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Scholar Rock

Head of Biomarker Development

Reposted 5 Days Ago
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In-Office
Cambridge, MA
240K-330K Annually
Expert/Leader
In-Office
Cambridge, MA
240K-330K Annually
Expert/Leader
The Head of Biomarker Development will set the biomarker strategy, oversee assay development, and contribute to regulatory submissions for neuromuscular and rare diseases.
The summary above was generated by AI
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.

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

Top Skills

Digital Pathology
Imaging Biomarkers
Immunoassays
Lc-Ms
Multiparameter Flow Cytometry
Rna-Seq
Simoa

Scholar Rock Cambridge, Massachusetts, USA Office

301 Binney St, , Cambridge, Massachusetts , United States, 02142

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