Senior Director, Toxicology (CNS Specialist)
Centessa Pharmaceuticals
August 06, 2026
On-site
Boston, MA
Clinical Research and Development
Key Responsibilities
- Define and execute nonclinical safety strategies for assigned small molecule CNS programs across discovery, IND-enabling, and clinical development stages.
- Develop safety strategies for new CNS targets, lead optimization programs, and platform technologies.
- Identify gaps/emerging risks and implement risk mitigation plans (engage external experts as appropriate).
- Stay current on scientific literature and regulatory guidance for CNS toxicology.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies (CNS-relevant endpoints/models).
- Lead outsourcing for design, monitoring, execution, and reporting of nonclinical toxicology studies; ensure quality, compliance, and timely delivery.
- Manage/monitor CRO studies; review and edit study reports and coordinate finalization.
- Integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform decisions.
- Author/critically review toxicology sections of pre-IND/IND/CTA/IB/DSUR/NDA documents; prepare written responses to health authorities.
- Collaborate cross-functionally (biology, DMPK, pathology, pharmacology, clinical, regulatory, CMC); provide mentorship to entry-level toxicology staff.
Qualifications
- PhD (Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related); board certification (e.g., DABT, ERT).
- 13+ years pharma/biotech R&D in nonclinical and regulatory toxicology.
- Substantial CNS/neuroscience drug development experience.
- Expertise across discovery, IND-enabling, and early clinical development for CNS-active small molecules.
- Experience as toxicology lead on cross-functional programs.
- Extensive experience with global regulatory submissions and health authority responses.
- Working knowledge of FDA/EMA/ICH guidance and GLP; understanding of QA/regulatory/clinical interfaces.
- Proven success leading outsourced studies and managing CRO study directors.
- Strong ability to integrate datasets; work independently; excellent scientific writing and communication.
- Travel up to 25%–30%.
Compensation/Benefits
- Annual base salary range: $260,000–$295,000; discretionary annual bonus.
- 401(k), company-sponsored medical/dental/vision/life insurance, paid time off, health and wellness program.
- Define and execute nonclinical safety strategies for assigned small molecule CNS programs across discovery, IND-enabling, and clinical development stages.
- Develop safety strategies for new CNS targets, lead optimization programs, and platform technologies.
- Identify gaps/emerging risks and implement risk mitigation plans (engage external experts as appropriate).
- Stay current on scientific literature and regulatory guidance for CNS toxicology.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies (CNS-relevant endpoints/models).
- Lead outsourcing for design, monitoring, execution, and reporting of nonclinical toxicology studies; ensure quality, compliance, and timely delivery.
- Manage/monitor CRO studies; review and edit study reports and coordinate finalization.
- Integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform decisions.
- Author/critically review toxicology sections of pre-IND/IND/CTA/IB/DSUR/NDA documents; prepare written responses to health authorities.
- Collaborate cross-functionally (biology, DMPK, pathology, pharmacology, clinical, regulatory, CMC); provide mentorship to entry-level toxicology staff.
Qualifications
- PhD (Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related); board certification (e.g., DABT, ERT).
- 13+ years pharma/biotech R&D in nonclinical and regulatory toxicology.
- Substantial CNS/neuroscience drug development experience.
- Expertise across discovery, IND-enabling, and early clinical development for CNS-active small molecules.
- Experience as toxicology lead on cross-functional programs.
- Extensive experience with global regulatory submissions and health authority responses.
- Working knowledge of FDA/EMA/ICH guidance and GLP; understanding of QA/regulatory/clinical interfaces.
- Proven success leading outsourced studies and managing CRO study directors.
- Strong ability to integrate datasets; work independently; excellent scientific writing and communication.
- Travel up to 25%–30%.
Compensation/Benefits
- Annual base salary range: $260,000–$295,000; discretionary annual bonus.
- 401(k), company-sponsored medical/dental/vision/life insurance, paid time off, health and wellness program.