Description of Role
Centessa is seeking a Senior Director, Toxicology to provide scientific and technical leadership for nonclinical safety in our CNS programs. The Senior Director will drive program-level toxicology strategy from target selection and lead optimization through IND-enabling activities, clinical advancement, and NDA submission, with a particular focus on CNS small molecules. The successful candidate will work independently to direct their own program work, provide day-to-day scientific guidance to entry-level toxicology staff, and collaborate closely with peers across nonclinical and development functions. The Senior Director will own design, oversight, and interpretation of toxicology and safety pharmacology studies executed at CROs and will author the toxicology contributions to global regulatory submissions.
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.
- Proactively identify gaps and emerging risks within assigned programs and implement risk mitigation plans, engaging external experts as appropriate.
- Maintain a current understanding of scientific literature and regulatory guidance relevant to CNS toxicological assessment, and sustain a professional network of external subject matter experts to inform program strategy.
- Design, oversee, and interpret GLP, non-GLP, investigative, and in vitro toxicology and safety pharmacology studies, with emphasis on endpoints and models relevant to CNS-active small molecules.
- Lead outsourcing efforts for the design, monitoring, execution, and reporting of nonclinical toxicology studies, ensuring scientific quality, regulatory compliance, and timely delivery.
- Manage and monitor outsourced toxicology and safety pharmacology studies at external CROs, interacting effectively with CRO study directors throughout study conduct.
- Critically review and edit nonclinical study reports and coordinate report finalization with CROs.
- Integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform candidate selection and program decisions.
- Author and critically review the toxicology sections of global regulatory documents, including pre-IND packages, INDs, CTAs, IBs, DSURs, and NDA submissions.
- Prepare science-based written responses to nonclinical inquiries from health authorities (FDA, EMA, and other global regulators).
- Collaborate closely with peers in biology, DMPK, pathology, pharmacology, clinical, regulatory, and CMC to ensure toxicology activities and findings are integrated into overall program plans.
- Provide day-to-day scientific direction and mentorship to entry-level toxicology staff supporting assigned programs.
- Work independently to plan, prioritize, and deliver on program toxicology objectives.
Qualifications
- PhD in Toxicology, Pharmacology, Pathology, Neuroscience, DVM, or related discipline; board certification (e.g., DABT, ERT).
- 12+ years of pharmaceutical or biotechnology R&D experience with a strong track record in nonclinical and regulatory toxicology, including substantial experience supporting CNS / neuroscience drug development (required).
- Deep expertise supporting small molecule programs across discovery, IND-enabling, and early clinical development, with demonstrated experience advancing CNS-active candidates.
- Demonstrated experience serving as the toxicology lead on cross-functional drug development programs.
- Extensive experience authoring and reviewing nonclinical sections of global regulatory submissions (IND/CTA/IB/DSUR/NDA) and preparing written responses to health authority inquiries.
- Strong working knowledge of FDA, EMA, and ICH guidance documents and GLP regulations, with a solid understanding of how QA, regulatory, and clinical functions interface with nonclinical safety assessment.
- Demonstrated success leading outsourcing and oversight of toxicology and safety pharmacology studies and managing CRO study directors and partnerships.
- Strong ability to integrate complex nonclinical datasets across toxicology, pathology, DMPK, and pharmacology to inform development decisions.
- Proven ability to work independently, set priorities, and deliver high-quality program output without close supervision, while collaborating effectively with peers across functions.
- Excellent verbal communication and scientific writing skills as applied to study reports and regulatory documents.
- Sense of urgency, detail orientation, and ability to thrive in a hands-on, growth stage environment.
Compensation
The annual base salary range for this position is $160,000.00 to $250,000.00. Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
In addition to base pay, this role is eligible for a discretionary annual bonus. Centessa also offers a comprehensive benefits package, which includes a 401(k) plan, company-sponsored medical, dental, vision, and life insurance, generous paid time off, and a health and wellness program.
Work Location
The Senior Director, Head of Toxicology role is a remote role based in the US, with regular travel (up to 25%-30%).
POSITION: Full-Time, Exempt
EEOC Statement: Centessa Pharmaceuticals, a wholly owned subdisary of Eli Lilly and Company believes in a diverse environment and is committed to equal employment opportunity for all its employees and qualified applicants. We do not discriminate in recruitment, hiring, training, promotion, or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. We will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Please note: We will not assign referral rights for any unsolicited resumes from recruitment agencies.
