Scholar Rock

Vice President, Preclinical Sciences

Scholar Rock

full-time

Posted on:

Origin:  • 🇺🇸 United States • Massachusetts

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Job Level

Lead

About the role

  • 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.
  • 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.
  • 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.

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.