Senior Advisor, Study Operations Manager - Nonclinical Toxicology (remote)

Lilly • Indianapolis, IN

1d • $144,000 - $231,000 • Remote

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking an experienced Senior Advisor, Study Operations - Nonclinical Toxicology. Centessa is a clinical-stage company developing orexin receptor 2 (OX2R) agonists, including cleminorexton, for narcolepsy and potentially other sleep-wake disorders, with additional clinical and preclinical-stage assets for neurological, neurodegenerative, and neuropsychiatric conditions.

The role manages and oversees day-to-day operations for toxicology and safety pharmacology studies conducted at selected CROs. Responsibilities span study forecasting, budgeting, planning, data management, quality assurance, compliance, communications, and collaboration with functional teams across the orexin agonist portfolio. The position supports expansion of translational science and nonclinical development capabilities and calls for accuracy, attention to detail, and the ability to identify and resolve issues during studies.

Requirements

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

Nice To Haves

• 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 and IT savvy.
• Intrinsic curiosity and deep passion for the work.
• Ability to embrace ambiguity and push for new practices and technologies.
• Adaptive problem-solving skills, including turning issues into opportunities and translating ideas into solutions when the path is unclear.

Responsibilities

• Manage end-to-end data flow between external CROs and internal teams, ensuring accuracy, consistency, and alignment with study objectives.
• Initiate draft statements of work with multiple CROs for awarded studies, collaborating with toxicology project representatives to ensure study-design accuracy and timely execution.
• Coordinate with CRO study directors to initiate internal review of draft study protocols and reports for toxicology and safety pharmacology studies with DMPK, CMC, and bioanalytical team members.
• Coordinate compound shipments with the 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 progress updates to relevant team members, regulatory leads, and senior management to advance drug candidates through research and development.
• Maintain an integrated calendar with the Project Management team to forecast study deliverables across the portfolio and support efficient resource planning.
• Attend project meetings to stay informed, expedite study-related activities as needed, and provide updates to project teams upon request.

Benefits

• Company bonus, depending in part on company and individual performance, for full-time equivalent employees.
• Eligibility to participate in a company-sponsored 401(k).
• Pension.
• Vacation benefits.
• Eligibility for medical, dental, vision, and prescription drug benefits.
• Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
• Life insurance and death benefits.
• Certain time-off and leave-of-absence benefits.
• Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior