Associate Director/Director of Toxicology
Scorpion Therapeutics, Cambridge, MA, United States
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 fostering collaborative CRO interactions to deliver timely and high-quality toxicology data, maintain 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.