Director of Toxicology

Role Summary

Director of Toxicology responsible for creating and executing the nonclinical safety strategy. The successful candidate will provide operational oversight and interpretation/communication of toxicology data to support Scholar Rock’s discovery and development portfolio. Reporting to the Vice President, Head of Preclinical Sciences, this individual will design and implement fit-for-purpose toxicology approaches (including NAMs), oversee studies conducted at CROs, interpret safety data, and contribute to program strategy and regulatory submissions. The role includes membership on the Research Leadership Team.

Responsibilities

• Define and drive the toxicology testing strategy across preclinical and clinical programs, ensuring alignment with overall portfolio goals.
• Serve as a PreClinical Science thought leader, integrating existing and emerging toxicological approaches into program strategy and clinical development plans in support of program advancement and key regulatory milestones.
• Represent toxicology in cross-functional governance and portfolio planning forums.
• Partner with other functions (Translational Biomarkers, Research, and clinical teams) to guide evaluation of targets and programs to contextualize nonclinical safety findings.
• Operational excellence of Toxicology Function: includes fostering collaborative CRO interactions to deliver timely and high-quality toxicology data, and maintaining timelines, costs, and risk management.
• Leverage existing and emerging NAMs to support the advancement of monoclonal antibodies across the research and development portfolio.
• Lead the design and execution of toxicology studies, working cross-functionally to incorporate bioanalytical and translational biomarkers to address nonclinical safety questions.
• Author and review toxicology sections of INDs, CTAs, IBs, CSRs, and other regulatory filings.
• Collaborate with Clinical Development to understand the potential relevance of nonclinical safety signals.
• Distill large nonclinical safety datasets for key messaging; interpret and communicate findings to key stakeholders within Research and Development.
• Contribute to the evaluation of novel modalities and combination strategies to support advancement of Scholar Rock’s portfolio.

Qualifications

• PhD in biology, toxicology, pharmacology, veterinary medicine, or related discipline; DABT Certification strongly preferred.
• 10+ years of toxicology experience within biotech/pharma; proficiency in the development of monoclonal antibodies preferred.
• Familiar with GLP requirements and ICH guidelines.
• Experience in the design, conduct, and interpretation of nonclinical safety studies and the management of external CROs.
• Strong analytical and communication skills; ability to distill complex data into key messages for stakeholders and regulatory submissions.
• Proficient in scientific documentation supporting submissions to regulatory agencies.
• Passion for rare disease research and a commitment to improving patients’ lives.