Senior Safety Physician, CNS – Late-Stage

Lilly; Boston (MA); Remote; USD 222,000 - 356,000; Full time

Benefits offered by this job

Company bonus

Job summary

Centessa Pharmaceuticals, a clinical-stage company and subsidiary of Eli Lilly, is seeking a Senior Safety Physician to lead medical safety for late-stage CNS programs. You will review safety data, manage risk, and contribute to NDA submissions, reporting to the Associate Vice President of Pharmacovigilance.

You'll collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to drive safety evidence generation, signal evaluation, and regulatory interactions.

Qualifications

• MD, DO, or equivalent medical degree.
• 5+ years of pharmaceutical/biotech Drug Safety or pharmacovigilance experience.
• Experience with late-stage development and NDA submissions.
• Ability to drive drug safety evidence generation and risk mitigation strategies.
• Sound knowledge of FDA, EMA/EU, ICH pharmacovigilance guidelines.

Responsibilities

• Provide medical safety oversight for Phase 2/3 and other late-stage studies.
• Review and interpret individual and aggregate safety data; identify and evaluate signals.
• Lead or contribute to safety surveillance, signal management, literature surveillance and benefit-risk assessments.
• Provide medical input into DSURs, PBRERs/PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions.
• Support regulatory interactions and responses to FDA and other health authorities globally.
• Partner with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs.
• Provide safety input into clinical protocols, safety monitoring plans, and development strategies.
• Support preparation for regulatory submissions, inspections, and audits.
• Communicate safety findings and recommendations to cross-functional teams and senior leadership.
• Help build the medical safety function at Centessa: SOPs, gap analyses, and collaboration with Global Safety at Lilly.

Skills

Clinical judgment

Scientific communication

Interpersonal skills

Cross-functional collaboration

Education

MD/DO or equivalent medical degree

Job description

Centessa Pharmaceuticals, a clinical-stage company and subsidiary of Eli Lilly, is seeking a Senior Safety Physician to lead medical safety for late-stage CNS programs. You will review safety data, manage risk, and contribute to NDA submissions, reporting to the Associate Vice President of Pharmacovigilance.

You'll collaborate with Clinical Development, Regulatory Affairs, Medical Affairs, and other functions to drive safety evidence generation, signal evaluation, and regulatory interactions.