Associate Director, Clinical Affairs

About This Role

As an Associate Director, you will manage senior managers and professionals, overseeing multiple projects and initiatives within Clinical Affairs. You will develop talent, identify risks, and ensure compliance with regulatory requirements.

Responsibilities

• Manage senior managers, managers, and professionals to oversee multiple projects and/or initiatives.
• Develop a robust talent development plan aligning with functional growth strategies.
• Identify risk, develop and lead the implementation of broad and complex projects, initiatives, and/or strategies.
• Develop mitigation strategies and alternative solutions in collaboration with cross-functional teams.
• Plan and direct complex activities with large scale or significant business impact.
• Oversee relationship management with physicians/investigators, medical professionals, CRO's, hospitals, research institutions, and/or vendors.
• Ensure compliance to applicable regulatory requirements including safety reporting and device related complications.
• Oversee clinical studies/registries from initiation to completion, ensuring study compliance and data completeness.
• Serve as a point of escalation for complex project issues.
• Oversee the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators.
• Oversee the accuracy/effectiveness of device accountability.

Requirements

• Bachelor Degree or 8-10 years of end-to-end leadership of clinical studies/registries in regulated environments (Device, pharma, or Clinical Research Operations)
• 10-15 years of relevant professional experience in clinical research/operations/trial management in a regulated environment
• 5+ years in clinical research, clinical operations, or trial management
• 5+ years in people leadership, ideally managing managers or leading sizable cross-functional teams
• Experience overseeing complex, high-impact programs in a regulated environment (medical device, pharma, CRO, or clinical research preferred)
• Demonstrated experience leading managers and senior managers across multiple concurrent projects or initiatives
• Strong risk assessment, mitigation planning, and issue-resolution skills within complex, cross-functional environments
• Experience overseeing clinical studies/registries from initiation through completion, ensuring compliance and data integrity
• Solid understanding of regulatory requirements, including safety reporting and device-related event oversight

Qualifications

• Bachelor Degree
• 10-15 years of relevant professional experience (clinical research/operations/trial management in a regulated environment), including 5+ years in clinical research, clinical operations, or trial management and 5+ years in people leadership.

Nice to Have

• Experience serving as an escalation point for IRB interactions, contracts, training, and complex study issues (Institutional Review Board)
• Background supporting clinical trial teams during live case support with physicians and hospital staff
• Familiarity with device accountability processes and oversight procedures