Senior Safety Physician - CNS (remote)

Lilly • Indianapolis, IN

16h • $222,000 - $393,800 • 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 other sleep-wake disorders, with potential applications across additional neurological, neurodegenerative, and neuropsychiatric conditions. Centessa is seeking a Senior Safety Physician to provide medical safety leadership for a late-stage CNS clinical development program. The role contributes to safety evidence generation, signal evaluation, risk management, benefit-risk assessment, and regulatory submissions through NDA.

The Senior Safety Physician oversees safety data, including medical review and assessment of individual case safety reports and aggregate reports. The role collaborates with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, and other cross-functional teams to identify, assess, characterize, and communicate emerging safety signals and risks. The position reports to the Associate Vice President of Pharmacovigilance and Safety.

The physician will also help build Centessa’s medical safety function by conducting gap analyses, authoring and reviewing SOPs, implementing best practices, and partnering as needed with Eli Lilly’s broader Global Safety function. The position is remote. The anticipated salary range is $222,000–$393,800. Eligible full-time employees may receive a company bonus and participate in a comprehensive benefits program.

Requirements

• MD, DO, or equivalent medical degree.
• At least 5 years of pharmaceutical or biotech industry experience in Drug Safety/Pharmacovigilance or a closely related discipline.
• Demonstrated experience with late-stage clinical development, NDA submissions, and post-marketing activities.
• Ability to drive drug safety evidence generation and risk mitigation strategies in complex internal and external environments.
• Expertise in safety signal evaluation, aggregate safety assessment, and benefit-risk evaluation.
• Sound knowledge and experience with FDA, EMEA/EU, ICH, and other global pharmacovigilance and risk management regulations and guidelines.
• Strong clinical judgment, scientific communication, interpersonal, and cross-functional collaboration skills.
• Ability to thrive in a fast-paced, entrepreneurial biotech environment.

Nice To Haves

• Experience supporting a CNS program through late-stage development and NDA submission or approval.
• Experience with regulatory interactions and integrated safety analyses.
• Intrinsic curiosity and deep passion for the work.
• Willingness 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.
• Technical depth and a growth mindset, with the ability to pursue potential impact with intention and energy.
• Curiosity and drive to identify innovation, especially in artificial intelligence and digital.

Responsibilities

• Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies.
• Review and interpret individual and aggregate safety data, including identifying and evaluating safety 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 the 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 by conducting gap analyses, authoring and reviewing SOPs, implementing best practices, and partnering with Eli Lilly’s Global Safety function as needed.

Benefits

• Company bonus, depending in part on company and individual performance.
• Company-sponsored 401(k) participation eligibility.
• Pension.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits eligibility.
• 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
• Education Level: Ph.D. or professional degree