Senior Safety Physician: CNS Clinical Safety Leader

BioSpace; Indianapolis (IN); Presencial; USD 222.000 - 356.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company bonus

401(k) plan

Pension

Vacation benefits

Medical, dental, vision, and Rx

Flexible benefits

Life insurance

Well-being programs

Descripción de la vacante

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Safety Physician to lead safety oversight for late-stage CNS programmes and NDA submissions.

You will review safety data, manage signals, and contribute to DSURs and risk management plans, collaborating with cross-functional teams and regulators.

This role offers an opportunity to build the medical safety function within Centessa and Lilly with competitive compensation and comprehensive benefits.

Formación

• MD/DO or equivalent medical degree is required.
• 5+ years in Drug Safety/Pharmacovigilance or related field.
• Experience with late-stage development and NDA submissions.
• Strong clinical judgment and cross-functional collaboration.
• Knowledge of FDA/EMEA/ICH regulations and guidelines.
• Ability to thrive in a fast-paced biotech environment.

Responsabilidades

• Provide medical safety oversight for Phase 2/3 and other late-stage studies.
• Review safety data and evaluate safety signals.
• Lead safety surveillance, risk management, and benefit-risk assessments.
• Contribute to DSURs, PBRERs/PSURs, Risk Management Plans, and NDA submissions.
• Support regulatory interactions with FDA and global authorities.
• Collaborate with Clinical Development, Regulatory, Clinical Operations, Biostatistics, and Medical Affairs.
• Provide input on protocols and safety monitoring plans.
• Prepare for regulatory submissions, inspections, and audits.
• Communicate safety findings to cross-functional teams and leadership.
• Help build the medical safety function within Centessa and Lilly.

Conocimientos

Pharmacovigilance

Safety signal evaluation

NDA submissions

FDA regulatory knowledge

Cross-functional collaboration

Clinical judgment

Educación

MD/DO or equivalent medical degree

Descripción del empleo

Centessa Pharmaceuticals, a wholly owned subsidiary of Eli Lilly and Company, is seeking a Senior Safety Physician to lead safety oversight for late-stage CNS programmes and NDA submissions.

You will review safety data, manage signals, and contribute to DSURs and risk management plans, collaborating with cross-functional teams and regulators.

This role offers an opportunity to build the medical safety function within Centessa and Lilly with competitive compensation and comprehensive benefits.