Senior Safety Physician - CNS (remote)

Organization and Position Overview

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is a clinical-stage company developing orexin receptor 2 (OX2R) agonists as a new class of medicines for the treatment of narcolepsy and potentially other sleep-wake disorders. Centessa's lead investigational candidate – cleminorexton (formerly ORX750) – is being developed for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia. Centessa's OX2R agonist portfolio includes additional clinical and preclinical-stage assets with potential utility across a broader range of neurological, neurodegenerative, and neuropsychiatric conditions.

We are seeking a Senior Safety Physician to join our Drug Safety/Pharmacovigilance team and provide medical safety leadership for late-stage CNS clinical development programs. This is an opportunity to play a key role in safety evidence generation strategies, signal evaluation, risk management activities, benefit-risk assessment, and regulatory submissions through NDA. As a Senior Safety Physician, you will play a key role in the oversight of safety data including medical review and assessment of individual case safety reports and aggregate reports, partnering closely with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, Medical Affairs, and other cross-functional teams to ensure appropriate identification, assessment, characterization, and communication of emerging safety signals and risks. You will report to Associate Vice President of Pharmacovigilance and Safety.

Responsibilities

• Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies.
• Review and interpret individual and aggregate safety data, including identification and evaluation of 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 FDA and other health authorities globally.
• Partner closely 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 effectively to cross-functional teams and senior leadership.
• Play an active role in building up the medical safety function at Centessa: conduct gap analysis, author and review SOPs, implement best practices and partner as needed with the broader Global Safety function at Eli Lilly.

Basic Requirements

• MD, DO, or equivalent medical degree.
• 5+ years of pharmaceutical/biotech industry experience in Drug Safety/Pharmacovigilance or a closely related discipline.
• Demonstrated experience with late-stage clinical development and NDA submissions as well as post-marketing activities.
• Ability to drive drug safety evidence generation and risk mitigation strategies in a complex internal and external environment.
• 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.

Additional Preferences

• Experience supporting a CNS program through late-stage development and NDA submission/approval, as well as experience with regulatory interactions and integrated safety analyses.
• Intrinsically curious and deeply passionate about the work we do.
• Embrace ambiguity and push for new practices and technologies.
• Adaptive problem solver - turn issues into opportunities and translates ideas into solutions, even when the path isn't clear.
• Leverage technical depth and a growth mindset to make impact; imagine what's possible and pursue it with intention and energy.
• Demonstrate curiosity and drive self-identified innovation, especially in the exploration of artificial intelligence and digital.