Associate Director, Clinical Drug Safety

Lilly • Indianapolis, IN

1d • $117,000 - $189,200 • Remote

About The Position

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists for narcolepsy and potentially other sleep-wake disorders. The Associate Director, Clinical Drug Safety supports pharmacovigilance activities across Centessa’s clinical-stage development programs and reports to the Executive Director - Safety Science.

The role contributes to the review and analysis of safety data for ongoing safety surveillance, including signal management, and provides analytic and safety support for regulatory compliance and program execution. It also supports aggregate report production and literature review. The Associate Director works with cross-functional partners and external vendors to deliver high-quality safety work and maintain inspection-ready processes in a fast-paced, development-focused environment.

The position is US remote-based, with less than 10% travel to headquarters in Boston, Massachusetts.

Requirements

• RN, PhD, PharmD, MS, or BS degree in health sciences or a related field.
• At least 6 years of drug safety experience in the biotech or pharmaceutical industry, including at least 3 years of pharmacovigilance compliance experience.
• In-depth knowledge of safety signal identification, evaluation, and escalation processes, including governance frameworks and contribution to labeling updates.
• Demonstrated capability in aggregate safety data analysis, ongoing safety surveillance, and risk–benefit assessment for investigational products.
• Experience overseeing and interpreting medical literature surveillance to identify emerging safety information and assess clinical relevance.
• Strong expertise in scientific review and preparation of safety deliverables, including DSURs, line listings, aggregate safety summaries, Investigator’s Brochures, protocols, and regulatory submissions.
• Advanced knowledge of global drug safety and pharmacovigilance regulations, guidelines, and best practices, and their application to safety decision-making.
• Hands-on scientific expertise in ICSR and clinical trial SAE assessment, including causality, seriousness, expectedness, and regulatory reportability, with experience guiding SUSAR preparation.
• Ability to provide scientific and quality oversight of vendor-led safety activities, ensuring accuracy, consistency, and regulatory compliance.
• Technical proficiency as a drug safety subject matter expert on cross-functional teams, contributing to safety strategy, complex safety evaluations, and ad hoc scientific analyses.

Nice To Haves

• Advanced degree; PharmD or PhD strongly preferred.
• CNS experience preferred.
• Strong analytical skills, attention to detail, and comfort working across multiple programs.
• Clear communication skills and ability to work effectively in small, cross-functional teams.

Responsibilities

• Support implementation of signal identification and management strategy, coordinating discussions within the Drug Safety team and with cross-functional partners.
• Analyze aggregate safety data, identify emerging safety signals, and contribute to risk–benefit assessments for investigational products.
• Review adverse event and other safety-related data for signal detection.
• Oversee literature surveillance, interpret the clinical relevance of findings, and communicate them as appropriate.
• Coordinate signal reviews with Drug Safety and cross-functional teams.
• Support preparation of safety governance slides and documentation of meeting minutes.
• Provide scientific input into the preparation and review of aggregate reports, including DSURs and line listings.
• Oversee DSUR strategy, preparation, and adherence to timelines with cross-functional partners and vendors.
• Work with cross-functional partners to ensure high-quality safety data authorship for aggregate reports.
• Provide scientific input into safety-related sections of protocols, Investigator’s Brochures, and regulatory submissions.
• Serve as the lead drug safety representative on cross-functional study teams, shaping safety strategy, influencing program decisions, and advising on safety issue management in collaboration with senior Drug Safety colleagues.
• Maintain knowledge of therapeutic areas and evolving global drug safety regulations, guidelines, and best practices, applying this expertise to program decisions and safety governance.
• Collaborate with clinical development, clinical operations, regulatory, medical writing, and quality partners to provide scientific leadership on safety topics and align on safety strategy and interpretation.
• Review complex cases to ensure the scientific integrity and quality of safety data.
• Contribute to case narratives and guide scientific preparation of regulatory-ready case submissions, including SUSARs, in accordance with global reporting requirements.
• Oversee vendor-led ICSR and clinical trial SAE evaluations, ensuring medical accuracy, regulatory reportability, and global consistency through scientific review and quality governance.
• Lead or contribute to complex cross-functional safety projects, safety signal evaluations, and ad hoc scientific analyses.
• Ensure drug safety activities comply with evolving regulations.
• Support implementation, execution, and maintenance of safety processes.
• Support process improvement and consistency initiatives.

Benefits

• Company bonus for full-time equivalent employees, depending in part on company and individual performance.
• Company-sponsored 401(k).
• Pension.
• Vacation benefits.
• 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: Director