Guide safety teams in developing strategies and providing expert input for new marketing authorizations (e.g., BLA, MAA)
Oversee safety surveillance, signal detection, and risk management activities to ensure timely evaluation and mitigation of safety issues
Ensure high-quality medical safety contributions to clinical and regulatory documents across portfolio products
Build and lead a high-performing Safety Sciences team while fostering cross-functional collaboration and scientific excellence
Collaborate with global teams in R&D, Clinical Development, Regulatory Affairs, Medical Affairs, and external stakeholders to align on safety strategies
Balance resources effectively within the Safety Sciences team in partnership with Safety Strategy Leads
Requirements
Proven expertise in leading safety functions for new global marketing authorizations (e.g., BLA, MAA)
Strong experience in safety surveillance, signal detection, and risk management practices
Demonstrated ability to manage cross-functional teams in a global environment with high-quality outcomes
Excellent communication skills for effective collaboration with internal teams and external stakeholders such as CROs and Health Authorities
A strategic mindset with a focus on scientific excellence and compliance