Associate Director/Director of Toxicology

Strategic Leadership & Vision

• 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. 

Functional & Scientific Oversight

• Operational excellence of Toxicology Function: Includes the fostering of collaborative CRO interactions to deliver timely and high-quality toxicology data, maintenance of timelines, costs, and risk assessment/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.   

Candidate Requirements:

• 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.