Director, Toxicology jobs in United States
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Septerna · 11 hours ago

Director, Toxicology

Septerna is a biotechnology company based in South San Francisco, CA, focused on developing life-changing medicines targeting GPCRs. The Director of Toxicology will lead the toxicology function, ensuring safety pharmacology and toxicology studies are conducted in accordance with guidelines while overseeing the development of toxicology strategies for innovative drug discovery projects.

BiotechnologyInformation TechnologyMedicalSoftware
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H1B Sponsor Likelynote

Responsibilities

Develop, implement, and direct toxicology strategies, including integrated risk assessments, to support discovery and development programs across multiple disease indications
Support the planning and execution of Safety Pharmacology and Toxicology studies/data for all programs
Responsible for toxicology data analysis and interpretation, authoring nonclinical sections for regulatory documents including IND/CTA/IB/NDA
Oversee and coordinate nonclinical safety evaluations of drug candidates with CROs and consultants to ensure timely completion and delivery of high-quality data and study reports
Evaluate, interpret, and summarize toxicology results, providing proactive strategic direction to project teams
Address and resolve non-clinical safety issues arising in drug discovery and development programs and adequately assess the relevance of any toxicological findings to human safety
Design and initiate exploratory or investigational studies to further characterize safety findings as warranted
Maintain current knowledge of regulatory guidance, industry standards, and recommendations
Maintain a current understanding of modern methods for toxicological risk assessment, including in vitro, in vivo, and in silico approaches through literature review, scientific conferences, and interactions with advisors and key opinion leaders

Qualification

Toxicology expertisePharmaceutical experienceRegulatory knowledgeRisk assessmentCross-functional leadershipData analysisTeam collaborationCommunication skills

Required

V.M or PhD in Toxicology, Pathology, or closely related discipline, with 8+ years of pharmaceutical or biotech experience
Demonstrated experience in serving as the toxicology lead on cross-functional drug development teams
Expert knowledge of designing exploratory and definitive toxicology studies and conducting risk assessments to support small molecule drug development strategies
Knowledge of FDA, EMA, and ICH guidance documents and GLP regulations
Demonstrated experience in the preparation of INDs, CTAs, NDAs, and/or MAAs

Benefits

Benefits
Stock options
Annual target bonus for full-time positions

Company

Septerna

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Septerna is a biotech firm unlocking diverse drug discovery potential in G protein-coupled receptors across various diseases.

H1B Sponsorship

Septerna 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 (3)
2022 (1)

Funding

Current Stage
Public Company
Total Funding
$250M
Key Investors
RA Capital ManagementThird Rock Ventures
2024-10-25IPO
2023-09-12Acquired
2023-07-11Series B· $150M

Leadership Team

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Jeffrey Finer
CEO and Co-Founder
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Arthur Christopoulos
Co-Founder
Company data provided by crunchbase