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.
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
.png)
