Associate Director, Clinical Affairs

Description

We are the makers of possible

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. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.

Responsibilities

• 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 Skills/Experience:

• Bachelor Degree, will consider in lieu of education - 8-10 yrs End‑to‑end leadership of clinical studies/registries in regulated environments (Device, pharma, or Clinical Research Operations).

• 10–15 years of relevant professional experience (clinical research/operations/trial management in a regulated environment.

• To include:

• 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

Preferred Skills/Experience:

• 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.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

Why Join Us?

A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.

To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health.