Associate Director, Toxicology
Centessa Pharmaceuticals
6 hours ago
Remote
United States
Clinical Research and Development
Description Of Role
The Associate Director, Toxicology oversees toxicology and safety pharmacology studies conducted at CROs to support development of small molecule orexin receptor agonists. Manages outsourced toxicology studies with CRO partners to ensure regulatory compliance, scientific quality, and on-time delivery of study milestones and reports, contributing to toxicology packages for IND/CTA submissions and NDA filings.
Key Responsibilities
- Monitor nonclinical toxicology and safety pharmacology studies at external CROs (onsite or remotely) to ensure scientific quality and global regulatory compliance.
- Partner with the Lead Project Toxicologist to interpret findings and recommend next steps.
- Coordinate internal cross-functional review of draft protocols and reports with Toxicology Operations Manager and CRO Study Directors; engage DMPK, CMC, and bioanalytical teams as needed.
- Track study progress and deliverables; ensure timely data transfer, analysis, interpretation, and provide preliminary assessments.
- Maintain study monitoring reports prepared by internal/external study monitors.
- Participate in project sub-team meetings to expedite study-related activities and provide status updates upon request.
- Negotiate CRO reporting timelines/expectations and agree reporting plans to meet protocol requirements.
Qualifications
- Ph.D./M.D. in Toxicology/Pharmacology (or related) with 5–7 years nonclinical toxicology experience in biotech/pharma/CRO setting
- OR MS (Toxicology/Pharmacology/related) with 13+ years relevant CRO and/or pharma experience (including Safety Pharmacology)
- OR BS/BA (Toxicology/Pharmacology/Biology/related) with 15+ years relevant CRO and/or pharma experience (including Safety Pharmacology)
- DABT certification strongly preferred (not required)
- Prior hands-on oversight of outsourced nonclinical toxicology/safety pharmacology studies as a study monitor or CRO study director
- Strong GLP compliance knowledge and FDA/EMA/ICH guidance familiarity
Skills / Experience
- Ability to evaluate, interpret, and communicate toxicology data to cross-functional teams and senior leadership
- Strong organization; manages multiple concurrent studies, timelines, and high-quality documentation
- Excellent written/verbal communication; experience with regulatory documents and study summaries
- Skilled in negotiating timelines/deliverables with CRO Study Directors and partners
- Self-starter; experienced in toxicology study design and conduct
- Ability to make informed, real-time decisions during onsite CRO visits
Benefits
- Annual base salary range: $170,000.00 to $225,000.00
- Discretionary annual bonus; equity program participation
- 401(k), company-sponsored medical/dental/vision/life insurance, generous paid time off, health and wellness program
Work Location / Position
- Remote role based in the US with significant domestic and international travel (50%–60%)
- Full-time, Exempt
The Associate Director, Toxicology oversees toxicology and safety pharmacology studies conducted at CROs to support development of small molecule orexin receptor agonists. Manages outsourced toxicology studies with CRO partners to ensure regulatory compliance, scientific quality, and on-time delivery of study milestones and reports, contributing to toxicology packages for IND/CTA submissions and NDA filings.
Key Responsibilities
- Monitor nonclinical toxicology and safety pharmacology studies at external CROs (onsite or remotely) to ensure scientific quality and global regulatory compliance.
- Partner with the Lead Project Toxicologist to interpret findings and recommend next steps.
- Coordinate internal cross-functional review of draft protocols and reports with Toxicology Operations Manager and CRO Study Directors; engage DMPK, CMC, and bioanalytical teams as needed.
- Track study progress and deliverables; ensure timely data transfer, analysis, interpretation, and provide preliminary assessments.
- Maintain study monitoring reports prepared by internal/external study monitors.
- Participate in project sub-team meetings to expedite study-related activities and provide status updates upon request.
- Negotiate CRO reporting timelines/expectations and agree reporting plans to meet protocol requirements.
Qualifications
- Ph.D./M.D. in Toxicology/Pharmacology (or related) with 5–7 years nonclinical toxicology experience in biotech/pharma/CRO setting
- OR MS (Toxicology/Pharmacology/related) with 13+ years relevant CRO and/or pharma experience (including Safety Pharmacology)
- OR BS/BA (Toxicology/Pharmacology/Biology/related) with 15+ years relevant CRO and/or pharma experience (including Safety Pharmacology)
- DABT certification strongly preferred (not required)
- Prior hands-on oversight of outsourced nonclinical toxicology/safety pharmacology studies as a study monitor or CRO study director
- Strong GLP compliance knowledge and FDA/EMA/ICH guidance familiarity
Skills / Experience
- Ability to evaluate, interpret, and communicate toxicology data to cross-functional teams and senior leadership
- Strong organization; manages multiple concurrent studies, timelines, and high-quality documentation
- Excellent written/verbal communication; experience with regulatory documents and study summaries
- Skilled in negotiating timelines/deliverables with CRO Study Directors and partners
- Self-starter; experienced in toxicology study design and conduct
- Ability to make informed, real-time decisions during onsite CRO visits
Benefits
- Annual base salary range: $170,000.00 to $225,000.00
- Discretionary annual bonus; equity program participation
- 401(k), company-sponsored medical/dental/vision/life insurance, generous paid time off, health and wellness program
Work Location / Position
- Remote role based in the US with significant domestic and international travel (50%–60%)
- Full-time, Exempt