Senior Director, Toxicology (CNS Specialist)
Centessa Pharmaceuticals
17 days ago
Remote friendly (United States)
United States
Clinical Research and Development
Description of Role
- Senior Director, Toxicology providing scientific and technical leadership for nonclinical safety in CNS programs.
- Drive program-level toxicology strategy from target selection and lead optimization through IND-enabling activities, clinical advancement, and NDA submission (focus on CNS small molecules).
- Work independently; provide day-to-day scientific guidance to entry-level toxicology staff; collaborate across nonclinical and development functions.
- Own design, oversight, and interpretation of toxicology and safety pharmacology studies executed at CROs; author toxicology contributions to global regulatory submissions.
Key Responsibilities
- Define and execute nonclinical safety strategies for assigned small molecule CNS programs (discovery, IND-enabling, clinical development).
- Develop safety strategies for new CNS targets, lead optimization, and platform technologies.
- Identify gaps/risks and implement mitigation plans with external expert input.
- Maintain up-to-date knowledge of literature and CNS toxicology regulatory guidance; sustain expert network.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies.
- Lead outsourcing (design, monitoring, execution, reporting) with scientific quality, regulatory compliance, and timelines.
- Manage CRO study conduct and interact with CRO study directors.
- Critically review/edit study reports and coordinate finalization.
- Integrate nonclinical datasets across toxicology, pathology, DMPK, and pharmacology.
- Author/review toxicology sections of pre-IND, IND, CTA, IB, DSUR, and NDA documents.
- Prepare written responses to FDA/EMA and other regulators for nonclinical inquiries.
- Provide daily mentorship/direction to toxicology staff; plan/prioritize and deliver program objectives.
Qualifications
- PhD in 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 (required).
- Deep experience across discovery, IND-enabling, and early clinical development for small-molecule CNS-active candidates.
- Demonstrated toxicology lead on cross-functional programs.
- Extensive experience authoring/reviewing nonclinical sections of global regulatory submissions and responding to health authority inquiries.
- Knowledge of FDA/EMA/ICH guidance and GLP; understanding of QA/regulatory/clinical interfaces.
- Proven CRO outsourcing/oversight experience.
- Strong dataset integration skills across toxicology, pathology, DMPK, pharmacology.
- Strong independent priority-setting and scientific writing/communication.
- Travel up to 25%–30%.
Compensation & Benefits
- Base salary range: $275,000–$300,000.
- Discretionary annual bonus; 401(k); company-sponsored medical/dental/vision/life; generous paid time off; health and wellness program.
- Senior Director, Toxicology providing scientific and technical leadership for nonclinical safety in CNS programs.
- Drive program-level toxicology strategy from target selection and lead optimization through IND-enabling activities, clinical advancement, and NDA submission (focus on CNS small molecules).
- Work independently; provide day-to-day scientific guidance to entry-level toxicology staff; collaborate across nonclinical and development functions.
- Own design, oversight, and interpretation of toxicology and safety pharmacology studies executed at CROs; author toxicology contributions to global regulatory submissions.
Key Responsibilities
- Define and execute nonclinical safety strategies for assigned small molecule CNS programs (discovery, IND-enabling, clinical development).
- Develop safety strategies for new CNS targets, lead optimization, and platform technologies.
- Identify gaps/risks and implement mitigation plans with external expert input.
- Maintain up-to-date knowledge of literature and CNS toxicology regulatory guidance; sustain expert network.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies.
- Lead outsourcing (design, monitoring, execution, reporting) with scientific quality, regulatory compliance, and timelines.
- Manage CRO study conduct and interact with CRO study directors.
- Critically review/edit study reports and coordinate finalization.
- Integrate nonclinical datasets across toxicology, pathology, DMPK, and pharmacology.
- Author/review toxicology sections of pre-IND, IND, CTA, IB, DSUR, and NDA documents.
- Prepare written responses to FDA/EMA and other regulators for nonclinical inquiries.
- Provide daily mentorship/direction to toxicology staff; plan/prioritize and deliver program objectives.
Qualifications
- PhD in 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 (required).
- Deep experience across discovery, IND-enabling, and early clinical development for small-molecule CNS-active candidates.
- Demonstrated toxicology lead on cross-functional programs.
- Extensive experience authoring/reviewing nonclinical sections of global regulatory submissions and responding to health authority inquiries.
- Knowledge of FDA/EMA/ICH guidance and GLP; understanding of QA/regulatory/clinical interfaces.
- Proven CRO outsourcing/oversight experience.
- Strong dataset integration skills across toxicology, pathology, DMPK, pharmacology.
- Strong independent priority-setting and scientific writing/communication.
- Travel up to 25%–30%.
Compensation & Benefits
- Base salary range: $275,000–$300,000.
- Discretionary annual bonus; 401(k); company-sponsored medical/dental/vision/life; generous paid time off; health and wellness program.