Scholar Rock
Vice President, Head of Preclinical Sciences
Scholar Rock, Cambridge, Massachusetts, us, 02140
Overview
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. Responsibilities
Strategic Leadership & Vision: Set the scientific and operational strategy for Preclinical Sciences, encompassing nonclinical safety, DMPK, and bioanalytical sciences. Collaborate with Discovery, Clinical Development, Regulatory, and Quality to drive candidate advancement and risk mitigation. Provide thought leadership on IND readiness, dose/exposure rationale, and safety margins. Represent Preclinical Sciences in governance forums and cross-functional portfolio planning. Vendor management with third party vendors that meet industry standards. Regulatory & External Engagement: Own the strategy and preparation of preclinical sections of regulatory submissions, represent preclinical in portfolio planning, due diligence, and external collaborations; participate in agency interactions as scientific lead for nonclinical safety, DMPK, and PK/PD. Functional and Organizational Oversight: Oversee GLP and non-GLP toxicology studies; direct in vitro and in vivo DMPK studies; integrate bioanalysis, toxicokinetics, and biomarker strategies; drive translational hypotheses and PK/PD understanding; lead a high-performing team across toxicology, DMPK, and bioanalytical development. Partner with CROs and external consultants; develop risk mitigation plans. Candidate Requirements
PhD, DVM, or PharmD in pharmacology, toxicology, pharmaceutical sciences, or related discipline. 15+ years of relevant biotech/pharma R&D experience, including leadership of toxicology and preclinical development. Track record of leading regulatory filings (IND, BLA, etc.) and supporting early- and late-stage clinical development. 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 across functions. Background in biomarker strategy 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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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. Responsibilities
Strategic Leadership & Vision: Set the scientific and operational strategy for Preclinical Sciences, encompassing nonclinical safety, DMPK, and bioanalytical sciences. Collaborate with Discovery, Clinical Development, Regulatory, and Quality to drive candidate advancement and risk mitigation. Provide thought leadership on IND readiness, dose/exposure rationale, and safety margins. Represent Preclinical Sciences in governance forums and cross-functional portfolio planning. Vendor management with third party vendors that meet industry standards. Regulatory & External Engagement: Own the strategy and preparation of preclinical sections of regulatory submissions, represent preclinical in portfolio planning, due diligence, and external collaborations; participate in agency interactions as scientific lead for nonclinical safety, DMPK, and PK/PD. Functional and Organizational Oversight: Oversee GLP and non-GLP toxicology studies; direct in vitro and in vivo DMPK studies; integrate bioanalysis, toxicokinetics, and biomarker strategies; drive translational hypotheses and PK/PD understanding; lead a high-performing team across toxicology, DMPK, and bioanalytical development. Partner with CROs and external consultants; develop risk mitigation plans. Candidate Requirements
PhD, DVM, or PharmD in pharmacology, toxicology, pharmaceutical sciences, or related discipline. 15+ years of relevant biotech/pharma R&D experience, including leadership of toxicology and preclinical development. Track record of leading regulatory filings (IND, BLA, etc.) and supporting early- and late-stage clinical development. 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 across functions. Background in biomarker strategy 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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