Associate Director, Clinical Affairs

About the role

This is a senior leadership role responsible for end‑to‑end oversight of complex clinical studies and registries within a highly regulated environment. The role leads managers and teams across multiple large‑scale initiatives, partners closely with investigators, hospitals, CROs, and internal stakeholders, and ensures regulatory compliance, data integrity, and study execution from initiation through completion. Ideal candidates bring deep clinical operations experience, strong people leadership capability, and a proven ability to manage risk and deliver results across high‑impact, cross‑functional programs. Key responsibilities include: Manage senior managers, managers, and professionals to oversee the work of multiple projects and/or initiatives and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department. Identify risk, develop and lead in the implementation of broad and more complex projects, initiatives and/or strategies which may include negotiations with internal and external parties. Develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross functional and/or matrix teams Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables including but not limited to: Oversee the relationship management of physicians/investigators, other medical professionals, Research Organizations (CRO's), hospitals, research institutions and/or vendors Ensure compliance to applicable regulatory requirements including safety reporting and device related complications through appropriate oversight Oversee clinical studies/registries from initiation to completion, while ensuring study compliance and data completeness Serve as a point of escalation for complex project issues (e.g., sponsor site interaction for IRBs, contract, and training) Oversee the Clinical Affairs Trial Management Team during clinical trial cases with physicians, hospital staff and coordinators Oversee the accuracy/effectiveness of device accountability Required education and experience Bachelor's Degree (preferably in life sciences) At least 10 years of professional clinical research, clinical operations, or trial management in a regulated environment (Device, Pharma, or Clinical Research Operations). End‑to‑end leadership experience of clinical studies/registries At least 5 years of people management experience or leading sizeable cross functional teams Experience overseeing complex, high-impact programs in regulated environment (medical device research required) industry sponsored 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