Senior Safety Physician – CNS

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee medical safety for Phase 2/3 and other late-stage clinical trials.

• Analyze and interpret both individual and aggregate safety data, focusing on the identification and evaluation of safety signals.

• Lead or participate in safety surveillance, signal management, literature monitoring, and benefit-risk evaluations.

• Contribute medical insights for DSURs, PBRERs/PSURs, Risk Management Plans, Investigator's Brochures, and NDA submissions.

• Assist in regulatory interactions and responses to the FDA and other global health authorities.

• Collaborate with Clinical Development, Regulatory Affairs, Clinical Operations, Biostatistics, and Medical Affairs.

• Provide safety insights for clinical protocols, safety monitoring plans, and development strategies.

• Support the preparation for regulatory submissions, inspections, and audits.

• Effectively communicate safety findings and recommendations to cross-functional teams and senior leadership.

• Contribute to the establishment of the medical safety function at Centessa through gap analysis, drafting and reviewing SOPs, implementing best practices, and collaborating with Eli Lilly's broader Global Safety function.

• Report directly to the Associate Vice President of Pharmacovigilance and Safety.

⛳️ Requirements

• MD, DO, or an equivalent medical degree is required.

• A minimum of 5 years of experience in the pharmaceutical/biotech industry, specifically in Drug Safety/Pharmacovigilance or a closely related field.

• Proven experience in late-stage clinical development and NDA submissions, along with post-marketing activities.

• Capability to drive the generation of drug safety evidence and develop risk mitigation strategies within a complex internal and external landscape.

• Proficient in safety signal evaluation, aggregate safety assessment, and benefit-risk evaluation.

• Strong understanding and experience with FDA, EMEA/EU, ICH, and other global pharmacovigilance and risk management regulations and guidelines.

• Excellent clinical judgment, scientific communication, interpersonal skills, and ability to collaborate cross-functionally.

• Ability to excel in a fast-paced, entrepreneurial biotech setting.

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

🏝️ Benefits

• Company bonus based on both company and individual performance.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Comprehensive medical, dental, vision, and prescription drug benefits.

• Flexible benefits, including healthcare and/or dependent daycare flexible spending accounts.

• Life insurance and death benefits.

• Time off and leave of absence benefits.

• Well-being benefits, which include an employee assistance program, fitness benefits, and various employee clubs and activities.

• Employee resource groups that are open to all employees.