Senior Safety Physician – CNS

Job 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 to cross-functional teams and senior leadership
• Help build the medical safety function at Centessa through gap analysis, SOP authorship and review, best-practice implementation, 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
• Experience supporting a CNS program through late-stage development and NDA submission/approval, as well as experience with regulatory interactions and integrated safety analyses (Additional Preference)
• Curiosity and passion for the work
• Ability to embrace ambiguity and push for new practices and technologies
• Adaptive problem-solving ability
• Technical depth and growth mindset
• Curiosity and drive for innovation, especially in artificial intelligence and digital (Additional Preference)

Benefits:

• Company bonus depending, in part, on company and individual performance
• Company-sponsored 401(k)
• Pension
• 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 employee assistance program, fitness benefits, and employee clubs and activities
• Employee resource groups open to all employees