Director of Toxicology

Scholar Rock•Cambridge, MA

33d•$225,000 - $270,000

About The Position

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFÎ²) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role. Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the companyâ Summary of Position: Scholar Rock is seeking a Director of Toxicology that will be responsible for the creation and execution of the nonclinical safety strategy. The successful candidate will be responsible for operational oversight as well as the interpretation and communication of toxicology data to support the advancement of Scholar Rockâ 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 Rockâ

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 patientsâ

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 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 Rockâ