Senior Safety Physician – CNS

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

📋 Description

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

• Analyze and interpret individual and collective safety data, including the identification and assessment of safety signals.

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

• Offer 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 teams.

• Provide safety input into clinical protocols, safety monitoring plans, and development strategies.

• Aid in the preparation for regulatory submissions, inspections, and audits.

• Communicate safety findings and recommendations to cross-functional teams and senior management.

• Contribute to the establishment of the medical safety function at Centessa through gap analysis, SOP development and review, best-practice implementation, and collaboration 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.

• Over 5 years of experience in the pharmaceutical/biotech industry within Drug Safety/Pharmacovigilance or a closely related field.

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

• Capable of driving drug safety evidence generation and risk mitigation strategies within a complex internal and external landscape.

• Expertise in safety signal evaluation, aggregate safety assessments, and benefit-risk evaluations.

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

• Strong clinical judgment, along with excellent scientific communication, interpersonal, and cross-functional collaboration skills.

• Ability to succeed in a fast-paced, entrepreneurial biotech environment.

• Experience supporting a CNS program through late-stage development and NDA submission/approval, alongside experience with regulatory interactions and integrated safety analyses (Additional Preference).

• A genuine curiosity and passion for the work.

• Capability to navigate ambiguity and advocate for new practices and technologies.

• Adaptive problem-solving skills.

• Technical expertise and a growth-oriented mindset.

• A strong curiosity and drive for innovation, particularly in artificial intelligence and digital technologies (Additional Preference).

🏝️ Benefits

• Company bonus based, in part, on both company performance and individual contributions.

• Company-sponsored 401(k) plan.

• Pension plan.

• Vacation benefits.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 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 an employee assistance program, fitness benefits, and employee clubs and activities.

• Employee resource groups available to all employees.