Senior Safety Physician – CNS

Eli Lilly and Company

. Provide medical safety oversight for Phase 2/3 and other late-stage clinical studies .

Posted 10/6/2026full-timeRemote • Massachusetts • United StatesSenior💰 $222,000 - $356,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Drug Safety and Pharmacovigilance, with a strong focus on late-stage clinical development, safety signal evaluation, and regulatory submissions. Proven ability to communicate safety findings effectively and collaborate across cross-functional teams in a fast-paced biotech environment.

Highest-signal resume keywords

Drug Safety/Pharmacovigilance ExperienceSafety Signal EvaluationNDA Submission ExpertiseRegulatory Interaction with FDAClinical Development Knowledge

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Safety Data ReviewAggregate Safety AssessmentBenefit-Risk EvaluationRisk Management PlansClinical Protocol DevelopmentSafety Monitoring PlansLiterature SurveillanceSignal ManagementPharmacovigilance RegulationsPost-Marketing Activities

Soft Skills

Strong Clinical JudgmentScientific CommunicationInterpersonal SkillsCross-Functional CollaborationAdaptability in Fast-Paced Environments

Certifications & Qualifications

MDDO

Industry Keywords

Phase 2/3 Clinical StudiesDSURsPBRERsPSURsCNS Program ExperienceGlobal Safety FunctionEli Lilly PartnershipSOP AuthorshipRegulatory SubmissionsFDA Guidelines

About the role

Key responsibilities & impact

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 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
Help build the medical safety function at Centessa through gap analysis, SOP authorship and review, implementation of best practices, and partnership with Eli Lilly's broader Global Safety function
Report to the Associate Vice President of Pharmacovigilance and Safety

Requirements

What you’ll need

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
Preferred: Experience supporting a CNS program through late-stage development and NDA submission/approval, as well as experience with regulatory interactions and integrated safety analyses

Benefits

Comp & perks

Company bonus depending, in part, on company and individual performance
Company-sponsored 401(k)
Pension
Vacation benefits
Medical, dental, vision and prescription drug benefits
Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
Life insurance and death benefits
Time off and leave of absence benefits
Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
Employee resource groups open to all employees