Executive Director, Head of Toxicology
Centessa Pharmaceuticals
8 hours ago
Remote
United States
Clinical Research and Development
Description Of Role
- Executive Director/Head of Toxicology providing scientific and strategic leadership for nonclinical safety across discovery and development programs (small-molecule therapeutics).
- Leads toxicology and safety pharmacology strategy to support target selection, lead optimization, IND-enabling activities, and clinical advancement.
- Partners with cross-functional teams and represents nonclinical safety in regulatory interactions while building a high-performing toxicology organization.
Key Responsibilities
- Lead and mentor a team of toxicologists and technical staff.
- Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages.
- Provide toxicology and safety pharmacology input to cross-functional development teams.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology studies.
- Develop safety strategies for new targets, lead optimization programs, and platform technologies.
- Oversee toxicology and safety pharmacology studies internally and at CROs.
- Ensure scientific quality, compliance, and timely delivery of nonclinical outputs.
- Author and critically review toxicology sections of regulatory documents (pre-IND, IND, IBs).
- Partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues to drive integrated decision-making.
- Present nonclinical safety data and risk assessments to project teams and senior R&D leadership.
- Serve as the primary nonclinical safety representative in regulatory agency interactions.
- Support product defense and regulatory submissions with robust scientific rationale.
- Provide strategic guidance on safety issue resolution and investigational toxicology approaches.
- Contribute to portfolio-level planning and prioritization of nonclinical safety resources.
- Build scalable toxicology capabilities for a growing pipeline.
Qualifications
- PhD in Toxicology, Pharmacology, Pathology, DVM, or related discipline; board certification (e.g., DABT, ERT) preferred.
- 15+ years of pharmaceutical/biotechnology R&D experience with a strong track record in nonclinical and regulatory toxicology.
- Deep expertise in supporting small-molecule programs across discovery, IND-enabling, and early clinical development.
- Demonstrated experience defining and executing nonclinical safety strategies for diverse pipelines and novel biology.
- Proven leadership experience building, managing, and mentoring toxicology teams in a collaborative, matrixed environment.
- Extensive experience preparing/reviewing nonclinical sections of global regulatory submissions and engaging with health authorities (FDA, EMA).
- Ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology.
- Experience overseeing outsourced toxicology/safety pharmacology studies and managing CRO partnerships.
- Excellent communication and influencing skills; ability to partner across Early Development, Research, and Regulatory in a fast-paced environment.
Compensation & Benefits
- Annual base salary range: $320,000–$350,000.
- Discretionary annual bonus; participation in equity program.
- 401(k); company-sponsored medical, dental, vision, and life insurance; generous paid time off; health and wellness program.
Work Location & Position
- Remote role based in the US; occasional travel.
- Full-Time, Exempt.
- Executive Director/Head of Toxicology providing scientific and strategic leadership for nonclinical safety across discovery and development programs (small-molecule therapeutics).
- Leads toxicology and safety pharmacology strategy to support target selection, lead optimization, IND-enabling activities, and clinical advancement.
- Partners with cross-functional teams and represents nonclinical safety in regulatory interactions while building a high-performing toxicology organization.
Key Responsibilities
- Lead and mentor a team of toxicologists and technical staff.
- Define and execute nonclinical safety strategies across discovery, preclinical, and clinical stages.
- Provide toxicology and safety pharmacology input to cross-functional development teams.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology studies.
- Develop safety strategies for new targets, lead optimization programs, and platform technologies.
- Oversee toxicology and safety pharmacology studies internally and at CROs.
- Ensure scientific quality, compliance, and timely delivery of nonclinical outputs.
- Author and critically review toxicology sections of regulatory documents (pre-IND, IND, IBs).
- Partner with biology, DMPK, pathology, pharmacology, clinical, and regulatory colleagues to drive integrated decision-making.
- Present nonclinical safety data and risk assessments to project teams and senior R&D leadership.
- Serve as the primary nonclinical safety representative in regulatory agency interactions.
- Support product defense and regulatory submissions with robust scientific rationale.
- Provide strategic guidance on safety issue resolution and investigational toxicology approaches.
- Contribute to portfolio-level planning and prioritization of nonclinical safety resources.
- Build scalable toxicology capabilities for a growing pipeline.
Qualifications
- PhD in Toxicology, Pharmacology, Pathology, DVM, or related discipline; board certification (e.g., DABT, ERT) preferred.
- 15+ years of pharmaceutical/biotechnology R&D experience with a strong track record in nonclinical and regulatory toxicology.
- Deep expertise in supporting small-molecule programs across discovery, IND-enabling, and early clinical development.
- Demonstrated experience defining and executing nonclinical safety strategies for diverse pipelines and novel biology.
- Proven leadership experience building, managing, and mentoring toxicology teams in a collaborative, matrixed environment.
- Extensive experience preparing/reviewing nonclinical sections of global regulatory submissions and engaging with health authorities (FDA, EMA).
- Ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology.
- Experience overseeing outsourced toxicology/safety pharmacology studies and managing CRO partnerships.
- Excellent communication and influencing skills; ability to partner across Early Development, Research, and Regulatory in a fast-paced environment.
Compensation & Benefits
- Annual base salary range: $320,000–$350,000.
- Discretionary annual bonus; participation in equity program.
- 401(k); company-sponsored medical, dental, vision, and life insurance; generous paid time off; health and wellness program.
Work Location & Position
- Remote role based in the US; occasional travel.
- Full-Time, Exempt.