Scholar Rock

Vice President

• 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.

Vice President, Preclinical Sciences

Compliance

• Serve as the Quality Lead for Quality Systems and Compliance operations across the company and manage quality and compliance guidance to the quality function.
• Oversee and manage GxP Training, Document control, and QMS GxP operations—including change controls, deviations, CAPAs, complaints, audit records, and supplier management activities.
• Track and manage the lifecycle of quality system records to uphold the integrity and compliance of Scholar Rock’s Quality system.
• Ensure timely intake and triage of product complaints, accurate complaint documentation, timely escalation, and proper reconciliation with related systems and departments.
• Assign and manage GxP training via training system, monitor compliance, and generate training completion reports, as needed.
• Participate in validation efforts for new or updated GxP IT systems through review of documentation, execution of test scripts, and supporting change controls as needed.
• Compile and provide metrics related to Quality management system and suppliers for periodic Quality management review meetings.
• Implement and oversee Scholar Rock’s internal audit program.
• Facilitate continuous improvement initiatives to transform and maintain compliance, improving QMS business process efficiency.
• Support inspection readiness activities, as needed.
• Support regulatory submissions including but not limited to annual reports, IND/CTA updates, and/or marketing authorizations.
• Lead and manage the Quality Systems and Compliance team, including direct reports.
• Collaborate with the Head of Quality and site leadership to ensure alignment with corporate goals, customer expectations, and regulatory obligations (FDA, EU, and other global regulators).

Vice President, Preclinical Sciences

Director/Senior Director, Quality Systems and GxP Compliance