Key skills
LeadershipRisk ManagementCommunicationNegotiation
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
- Leads strategic oversight of device risk management activities
- Partners with CSRM Therapeutic Area leaders
- Defines strategy and standards for medical assessment of product quality observations and deviations
- Represents CSRM leadership on shared governance committees with Manufacturing and other enterprise stakeholders.
Requirements
- M.D. with 7–12 years of relevant experience in clinical safety, pharmacovigilance, or related safety disciplines, including 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