Senior Safety Physician - CNS

Eli Lilly and Company; Indianapolis (IN); Sur place; USD 222 000 - 356 000; Plein temps

Avantages offerts par ce poste

Company bonus

401(k) plan

Vacation benefits

Medical, dental, vision benefits

Flexible benefits

Life insurance

Résumé du poste

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Safety Physician to lead medical safety for late-stage CNS development and NDA submissions. This role provides safety leadership for Phase 2/3 studies, risk management, and regulatory interactions with FDA and other authorities.

You will collaborate with Clinical Development, Regulatory Affairs, Medical Affairs and Biostatistics to deliver safety evidence generation, DSURs, PSURs, and risk

Qualifications

• MD/DO or equivalent medical degree.
• 5+ years in Drug Safety/Pharmacovigilance in pharma/biotech.
• Experience with late-stage development and NDA submissions.
• Ability to drive safety evidence generation and risk mitigation.

Responsabilités

• Provide medical safety oversight for late-stage studies.
• Review safety data and evaluate signals.
• Lead safety surveillance and risk management activities.
• Contribute to DSURs, PBRERs/PSURs, and NDA submissions.
• Support regulatory interactions and global health authorities.

Connaissances

Drug safety

Regulatory knowledge

Signal evaluation

Cross-functional collaboration

Clinical judgment

Formation

MD/DO or equivalent

Description du poste

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

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. Headquartered in Boston, Massachusetts, Centessa was recognized as a Great Place to Work® in 2026. 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 program. 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.

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.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women's Initiative for Leading at Lilly (WILL).

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is

$222,000 - $356,400

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees,

• including eligibility to participate in a company-sponsored 401(k)
• pension
• vacation benefits
• eligibility for medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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