Senior Safety Physician, CNS & Late-Stage Trials

Eli Lilly; United States; On-site; USD 222,000 - 356,000; Full time

Benefits offered by this job

401(k)

Pension

Medical benefits

Dental benefits

Vision benefits

Flexible benefits

Well-being benefits

Job summary

Lilly is seeking a Senior Safety Physician to lead pharmacovigilance for late-stage CNS programs and to shape safety evidence strategies. You will oversee medical review of safety data, identify signals, and guide risk management across the development timeline.

You will contribute to DSURs, PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions while collaborating with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs.

Qualifications

• Experience in Drug Safety/Pharmacovigilance with NDA submissions.
• Ability to drive safety evidence generation and risk mitigation.
• Strong clinical judgment and scientific communication.

Responsibilities

• Provide medical safety oversight for Phase 2/3 and other late-stage studies.
• Review and interpret safety data including signals.
• Lead safety surveillance, signal management and benefit-risk assessments.
• Contribute to DSURs, PBRERs/PSURs, Risk Management Plans, and NDA submissions.
• Support regulatory interactions with FDA and other authorities.
• Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics and Medical Affairs.
• Provide safety input into clinical protocols and monitoring plans.
• Prepare for regulatory submissions, inspections, and audits.
• Communicate safety findings to cross-functional teams and leadership.
• Help build the medical safety function within Centessa/Lilly.

Skills

Clinical judgment

Scientific communication

Cross-functional collaboration

Pharmacovigilance expertise

Late-stage development experience

Education

MD/DO or equivalent medical degree

Job description

Lilly is seeking a Senior Safety Physician to lead pharmacovigilance for late-stage CNS programs and to shape safety evidence strategies. You will oversee medical review of safety data, identify signals, and guide risk management across the development timeline.

You will contribute to DSURs, PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions while collaborating with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs.