Key skills
LeadershipRisk ManagementCommunicationCollaborationNegotiation
About this role
Role Overview
- Provides strategic and operational leadership for a global Center of Excellence delivering medical and scientific expertise in device safety, health hazard oversight, and product quality medical risk assessment
- Sets clinical risk management strategy, governance, and compliant processes for medical support of devices and combination products across the full product lifecycle
- Accountable for leading the strategy and implementation of timely medical risk assessment in support of quality issues across developmental and commercial products
- Leads cross‑functional collaboration across CSRM Therapeutic Area leadership, device development, commercial, manufacturing, and regulatory organizations to ensure patient safety, regulatory compliance, and successful execution of the Company’s product portfolio
- Defines and owns the global safety strategy for interpretation of regulatory requirements related to medical safety contributions to drug devices and combination products across development and marketed products
- Provides strategic oversight of device risk management activities through Clinical Safety and Risk Management (CSRM) device experts in collaboration with Risk Management Safety Teams (RMSTs).
Requirements
- M.D. with 7–12 years of relevant experience in clinical safety, pharmacovigilance, or related safety disciplines
- 3–5 years of experience supporting manufacturing safety and/or drug device development
- Demonstrated scientific expertise, strong medical judgment, and the ability to communicate risk and benefit effectively
- Thorough familiarity with global regulatory agencies and regulatory expectations
- Proven leadership capability, including building and leading high‑performing, cross‑disciplinary teams with integrity and accountability
- Outstanding interpersonal, communication, and negotiation skills.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days