[Hiring] Associate Director, Study Operations Manager - Nonclinical Toxicology @Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company

Role Description

Centessa Pharmaceuticals is seeking an experienced Associate Director, Study Operations - Nonclinical Toxicology to manage and oversee day-to-day operations for toxicology and safety pharmacology studies conducted in the selected CROs. Responsibilities include:

• Study forecasting, budgeting, planning, data management, quality assurance, compliance, communications, and collaboration with different functional teams across the portfolio of Orexin agonist programs.
• Requires a high degree of accuracy, attention to detail, and the ability to identify and resolve issues that arise during the conduct of studies.

Key Responsibilities:

• Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives.
• Initiate draft SOWs with multiple CROs for awarded studies in collaboration with toxicology project representatives to ensure accuracy of study design and to execute SOWs in a timely fashion.
• Coordinate with CRO study director to initiate the internal reviewing process of draft study protocols and study reports for tox/safety pharm studies with DMPK, CMC, and bioanalytical team members.
• Coordinate compound shipments with CMC team.
• Monitor nonclinical toxicology and safety pharmacology studies at external CROs, onsite or remotely, to ensure scientific quality and compliance with global regulatory requirements.
• Track study deliverables and provide timely updates on study progress to relevant team members, regulatory leads, and senior management in order to advance drug candidates through research and development.
• Maintain an integrated calendar by working with Project Management team to forecast study deliverables across entire portfolio for efficient planning of resources.
• Attend project meetings to stay informed and expedite study-related activities as needed, and provide updates to project teams upon request.

Qualifications

• BSc or MSc in toxicology, pharmacology or a related discipline.
• Minimum 6 years of biotechnology or pharmaceutical industry experience in conducting nonclinical toxicology/safety pharmacology, ADME/DMPK studies with CROs and external development partners.
• Strong understanding of biological sciences and nonclinical research methodologies.
• Highly organized, with proven ability to manage multiple simultaneous toxicology/safety pharmacology, ADME/DMPK studies, timelines, and data deliverables.
• Proficient in scientific data analysis software packages, databases, and data management systems, with the ability to quickly learn and adapt to new software tools.
• Must have excellent communication (oral and written), listening, negotiation and interpersonal relationship skills.

Requirements

• Experience supporting CNS, neuroscience, sleep-wake, rare disease, or related therapeutic areas.
• Experience contributing to IND or CTA submissions.
• Familiarity with FDA, EMA, and ICH regulatory requirements.
• Experience working in fast-paced, matrixed biotechnology environments.
• Excellent organizational skills, IT savvy.

Benefits

• The annual base salary range for this position is $150,000.00 to $220,000.00.
• Individual compensation within this range will be determined based on a variety of factors, including qualifications, skills, relevant experience, job knowledge and location.
• This role is eligible for a discretionary annual bonus.
• The Company 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.

Company Description

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa’s lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026.