Senior Safety Physician – CNS

🔥 2 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $222k - $356.4k / year

⏰ Full Time

🟠 Senior

👻 Ghost score 0%

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Eli Lilly and Company

WebsiteLinkedInAll Job Openings

10,000+ employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

💰 $6.5M Post-IPO Debt - Eli Lilly on 2024-02

Pharmaceuticals • Healthcare • Biotechnology

Eli Lilly and Company is a multinational pharmaceutical company that researches, develops, manufactures, and markets prescription medicines across multiple therapeutic areas including diabetes, oncology, immunology, neuroscience, and pain. Headquartered in Indianapolis, Indiana, Lilly is known for its extensive R&D, clinical development, and global commercialization of biologic and small-molecule drugs. The company focuses on drug discovery, clinical trials, regulatory approvals, and large-scale pharmaceutical manufacturing and distribution.

📋 Description

• 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

• 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

• 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