Department: R&D: Non-Clinical
Reports To: Vice President of Non-clinical Development
FLSA Status: Exempt
Location: San Diego or Remote
The Director of Toxicology will oversee and manage non-clinical safety, efficacy, and toxicology studies in Longboard’s development pipeline, and interact directly with external consultants, clinical and non-clinical pharmacokinetic and pharmacology scientists, and CROs to design, conduct, troubleshoot, and interpret non-clinical studies to support regulatory submissions. The Director of Toxicology will competitively bid projects and oversee their conduct through completion. This role will act as non-clinical project lead on project teams, communicating results and issues, and will author and edit regulatory documents in collaboration with CMC, ADME, Clinical, and Regulatory colleagues.
- Work with the Vice President of Non-clinical Development to devise and implement development program strategy.
- Competitively outsource programs to qualified vendors and engage in protocol development and study execution.
- Address and resolve toxicological issues and assess the relevance of any toxicological findings to human safety.
- Ensure accurate and valid data analysis and timely completion of final reports.
- Engage in integrated risk assessment analysis.
- Communicate findings, progress and issues to project teams, management or other audiences as needed.
- Collaborate with Clinical Development, Clinical Operations, and Regulatory Affairs functions to author and deliver IND/CTA submissions, Investigator Brochures, DSURs, and other regulatory submissions as needed.
- Oversee conduct of later stage non-clinical studies to support clinical development programs through NDA submission.
- Maintain a current understanding of regulatory guidance, relevant literature and methodologies specific to Longboard’s pipeline programs.
- PhD or DVM in Toxicology, Pharmacology, or biological sciences required.
- 10+ years’ industry experience.
- DABT certification strongly preferred.
- Small molecule drug development experience across multiple therapeutic areas including central nervous system disorders is required.
- Experience working with multiple national and international CROs.
- Experience in authoring regulatory submissions and preparing detailed science-based responses to regulatory questions.
- Working knowledge of CMC and product quality, to enable impurity assessment and justification of specifications.
- Ability to manage multiple work streams and projects concurrently.
- Ability to synthesize disparate data sets to create an overall understanding of toxicological profile, exposure, and risk.
- Ability to problem-solve, research issues, and propose solutions.
- Excellent interpersonal and communication skills, both written and oral, and ability to communicate complex information succinctly.
- Effective and constructive collaborator.
- Ability to function independently in fast-paced, virtual environment.
- Strong working knowledge of GxP, FDA, and ex-US regulatory requirements for the conduct of non-clinical safety studies to support regulatory findings.