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The Director of Toxicology role at Scholarrock is an on-site position located in Cambridge, MA.

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Director of Toxicology

ScholarrockCambridge, MA1d ago

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 (TGFβ) 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 company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.

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 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 the incorporation of NAMs), oversee studies conducted at CROs, interpret and communicate safety data, and serve as a key contributor to program strategy and regulatory submissions. This individual will be a member of the Research Leadership Team.

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.

Scholar Rock is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Director of Toxicology

Strategic Leadership & Vision

Functional & Scientific Oversight

Candidate Requirements:

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