Director of Toxicology jobs in United States
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Scholar Rock · 10 hours ago

Director of Toxicology

Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases. They are seeking a Director of Toxicology responsible for creating and executing the nonclinical safety strategy and overseeing toxicology data interpretation to support the company's development portfolio.

BiopharmaBiotechnologyMedicalTherapeutics
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H1B Sponsor Likelynote

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
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

Qualification

Toxicology experienceMonoclonal antibodies developmentGLP requirements knowledgeICH guidelines familiarityDABT CertificationNonclinical safety studiesCRO managementAnalytical skillsScientific documentationPassion for rare diseasesCommunication skills

Required

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

Preferred

DABT Certification strongly preferred
Proficiency in the development of monoclonal antibodies preferred

Company

Scholar Rock

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Scholar Rock is a biopharmaceutical company that develops and discovers new medicines and treatments for the serious diseases.

H1B Sponsorship

Scholar Rock has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2021 (4)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
$743M
Key Investors
InvusFidelityARCH Venture Partners
2024-10-08Post Ipo Equity· $300M
2023-10-11Post Ipo Equity· $85M
2022-06-17Post Ipo Equity· $205M

Leadership Team

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Jay Backstrom
Chief Executive Officer
Company data provided by crunchbase