
Posted 7 hours ago
Associate Director, Clinical Affairs
BDAssociate Director, Clinical Affairs
Requirements
Bachelor's Degree in life sciences preferred, 10+ years clinical research or operations experience, 5+ years people management experience, Medical device research experience required
Skills
Clinical ResearchClinical OperationsMedical Device
About the role
Responsibilities
- Manage senior managers, managers, and professionals to oversee multiple projects and initiatives
- Develop talent development plans aligned with functional growth strategies
- Identify risks and implement complex projects, initiatives, or strategies
- Develop mitigation strategies and resolve issues in collaboration with cross-functional teams
- Oversee relationship management with physicians, investigators, CROs, hospitals, and vendors
- Ensure compliance with regulatory requirements, including safety reporting and device-related complications
- Oversee clinical studies and registries from initiation to completion
- Serve as a point of escalation for complex project issues such as IRB interactions and contracts
- Oversee the Clinical Affairs Trial Management Team during clinical trial cases
- Oversee the accuracy and effectiveness of device accountability
Requirements
- Bachelor’s Degree, preferably in life sciences
- At least 10 years of professional clinical research, clinical operations, or trial management in a regulated environment
- End-to-end leadership experience of clinical studies or registries
- At least 5 years of people management experience or leading sizeable cross-functional teams
- Experience overseeing complex, high-impact programs in a regulated medical device environment
- Demonstrated experience leading managers and senior managers across multiple concurrent projects
- Strong risk assessment, mitigation planning, and issue-resolution skills
- Solid understanding of regulatory requirements, including safety reporting and device-related event oversight
Preferred Qualifications
- Experience serving as an escalation point for IRB interactions, contracts, and training
- Background supporting clinical trial teams during live case support with physicians and hospital staff
- Familiarity with device accountability processes and oversight procedures
About the Company
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat.
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BD · Irvine
