AVP, Therapeutic Area Head, Clinical Safety and Risk Management

Role: Senior physician leader overseeing clinical safety assessment and risk management across multiple therapeutic areas, including investigational and marketed products. Objectives include providing strategic direction, ensuring high standards of pharmacovigilance, and supporting benefit-risk evaluations throughout the product lifecycle. Responsibilities encompass leading Safety Physicians and Medical Associates in safety surveillance, signal detection, and risk mitigation; participating in regulatory safety governance and global safety compliance; and collaborating cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and Epidemiology. The role involves representing the organization in regulatory interactions, maintaining oversight of safety issues, and leading pharmacovigilance system improvements. Leadership tasks include mentoring Safety Physicians, driving organizational effectiveness, and resource management. Qualifications include an MD or equivalent, with a preference for Board Certification, at least 3 years of post-medical training clinical experience, and 5+ years in pharmacovigilance or clinical safety, with a total industry experience of 9+ years. Preferred experience involves leading safety strategies in multiple therapeutic areas, especially oncology, and engaging with regulatory authorities. Must possess strong knowledge of global pharmacovigilance regulations, risk management practices, and cross-functional leadership skills. The position reports to the Vice President, CSRM, and requires hybrid work in the U.S. with travel. This senior role plays a critical part in ensuring patient safety, regulatory compliance, and enterprise safety strategy development.