Remote Associate Director, Clinical Drug Safety

Eli Lilly and Company; United States; Remote; USD 117,000 - 189,000; Full time

Benefits offered by this job

Remote‑based in the US

Travel to Boston ≤10%

Job summary

Centessa Pharmaceuticals, a subsidiary of Eli Lilly and Company, is seeking an Associate Director, Clinical Drug Safety to lead safety signal detection, DSUR strategy, and regulatory submissions across development programs. The role emphasizes cross‑functional collaboration, scientific leadership, and global compliance in a fast‑paced environment.

The position requires extensive drug safety experience, advanced knowledge of PV regulations, and the ability to oversee complex ICSR activities while

Qualifications

• RN, PhD, PharmD, MS, BS in health sciences or related field required.
• 6+ years of experience in drug safety in biotech/pharmaceutical industry with 3+ years pharmacovigilance compliance experience.
• In‑depth knowledge of safety signal identification, evaluation, and escalation processes, including governance frameworks.
• Experience overseeing and interpreting medical literature surveillance for emerging safety information and clinical relevance.
• Advanced knowledge of global drug safety regulations, guidelines and best practices.

Responsibilities

• Support signal detection and safety surveillance by analyzing aggregate safety data and identifying emerging safety signals.
• Oversee DSUR strategy, preparation and adherence to timelines with cross‑functional partners and vendors.
• Provide scientific input into safety sections of protocols, Investigator’s Brochures, and regulatory submissions; lead cross‑functional study team safety discussions.
• Guide ICSR and clinical trial SAE evaluations, ensuring medical accuracy and regulatory reportability.
• Ensure compliance with evolving safety regulations and governance; contribute to safety process improvements.

Skills

Drug safety

Pharmacovigilance

DSUR

ICSR

Regulatory submissions

Literature surveillance

Education

Health sciences degree (RN/PhD/PharmD/MS/BS)

Job description

Centessa Pharmaceuticals, a subsidiary of Eli Lilly and Company, is seeking an Associate Director, Clinical Drug Safety to lead safety signal detection, DSUR strategy, and regulatory submissions across development programs. The role emphasizes cross‑functional collaboration, scientific leadership, and global compliance in a fast‑paced environment.

The position requires extensive drug safety experience, advanced knowledge of PV regulations, and the ability to oversee complex ICSR activities while