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Vice President, Head of Preclinical Sciences en Scholar Rock

Scholar Rock · Cambridge, Estados Unidos De América · Onsite

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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 an accomplished and strategic leader to serve as Vice President, Head of Preclinical Sciences. This individual will be responsible for driving the strategy and execution of all preclinical development activities—including toxicology, DMPK, and bioanalytical sciences to enable IND submissions and support early and late clinical development of our biologics pipeline in neuromuscular and rare diseases. Reporting to the Chief Scientific Officer, the VP will shape preclinical strategy, lead cross-functional execution, and serve as a key contributor to regulatory filings and interactions, and lead all preclinical sciences planning.


Position Responsibilities:
  • Strategic Leadership & Vision
  • Set the scientific and operational strategy for Preclinical Sciences, encompassing nonclinical safety, DMPK, and bioanalytical sciences.
  • Serve as a senior leader within the Research organization, collaborating closely with Discovery, Clinical Development, Regulatory, and Quality to drive candidate advancement and risk mitigation.
  • Provide thought leadership and decision-making support on IND readiness, dose/exposure rationale, and safety margins.
  • Represent Preclinical Sciences in governance forums and cross-functional portfolio planning.
  • Provide strategic leadership in selecting and managing third party vendors that meet industry standards.

  • Functional and Organizational Oversight
  • Oversee GLP and non-GLP toxicology studies in partnership with internal scientists and external CROs.
  • Direct in vitro and in vivo DMPK studies, including pharmacokinetic studies to enable and inform clinical modeling and translational assessments.
  • Lead integration of bioanalysis, toxicokinetics, and potentially biomarker strategy into nonclinical programs to inform clinical development and regulatory submissions.
  • Drive the development of translational hypotheses and mechanistic understanding of safety, and PK/PD in relevant models.
  • Provide key scientific input to cross-functional program teams on preclinical results, their implications for clinical/regulatory strategy, and risk mitigation plans.
  • Lead and inspire a high-performing internal team spanning toxicology, DMPK, and bioanalytical development; foster a culture of scientific rigor, collaboration, and accountability.

  • Regulatory & External Engagement
  • Own the strategy and preparation of preclinical sections of regulatory submissions (IND, CTA, IB, BLA, briefing packages, etc.), in collaboration with regulatory and clinical colleagues.
  • Represent preclinical development in portfolio planning, due diligence, and external collaborations/partnerships.
  • Participate in regulatory agency interactions as the scientific lead for nonclinical safety, DMPK, and PK/PD.
  • Cultivate productive partnerships with CROs, and external consultants, to expand capabilities and ensure quality.


    • Candidate Requirements:
  • PhD, DVM, or PharmD in pharmacology, toxicology, pharmaceutical sciences, or related discipline.
  • 15+ years of relevant experience in biotech/pharma R&D, including leadership of toxicology and preclinical development.
  • Demonstrated track record of leading successful regulatory filings (IND, BLA, etc.) and supporting early- and late-stage clinical development programs.
  • Expertise in biologics (e.g., monoclonal antibodies, fusion proteins) strongly preferred.
  • Deep understanding of GLP regulatory requirements, translational science, and nonclinical study design.
  • Experience overseeing CROs, external consultants, and cross-functional program teams.
  • Strong leadership, team building, and communication skills; ability to influence functions and levels.
  • Background in developing and implementing biomarker strategies to inform drug development across preclinical and clinical stages is desirable.
  • Passion for rare disease research and mission-driven science.


    • Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. 
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