Sr Director, Toxicology/ Nonclinical Dev
A leading biopharmaceutical company is seeking a highly experienced and strategic Director or Senior Director of Toxicology & Nonclinical Development to lead preclinical safety and ADME efforts across its pipeline. This role is pivotal in shaping nonclinical strategy, managing outsourced studies, and ensuring regulatory compliance for advancing drug candidates toward clinical development.
The ideal candidate will bring deep expertise in toxicology, pharmacokinetics, and regulatory science, with a proven track record of managing CROs and delivering high-quality data in both GLP and non-GLP environments.
Key Responsibilities
- Lead the design, execution, and interpretation of toxicology and ADME studies for investigational drug candidates.
- Serve as Study Director for outsourced preclinical studies, ensuring scientific integrity and regulatory compliance.
- Manage relationships with Contract Research Organizations (CROs), overseeing study conduct, timelines, and deliverables.
- Provide strategic input into candidate selection, IND-enabling studies, and overall nonclinical development plans.
- Ensure alignment with global regulatory requirements (FDA, EMA, ICH) for preclinical safety assessment.
- Collaborate cross-functionally with clinical, regulatory, and discovery teams to support submissions and development milestones.
- Represent nonclinical development in regulatory interactions, including pre-IND and IND meetings.
Qualifications
Required:
- Minimum 10 years of experience in preclinical toxicology and ADME within the pharmaceutical or biotechnology industry.
- Demonstrated success in leading drug development programs from discovery through IND.
- Extensive experience managing GLP and non-GLP studies through external CROs.
- Strong understanding of regulatory toxicology and safety pharmacology requirements.
- Expertise in study design, execution, and data interpretation.
Preferred:
- DABT certification (Diplomate of the American Board of Toxicology).
- Ph.D. in Toxicology, Pharmacology, or related field (Master's acceptable with DABT and strong experience).
- Experience with small molecules or biologics; therapeutic area flexibility.
- Prior experience in virtual or decentralized research environments.
Work Environment & Culture
- High autonomy and strategic influence in a lean, science-driven organization.
- Flexible schedule with a 4-day workweek (Monday-Thursday).
- Collaborative culture with direct access to executive leadership.
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