BD · 6 hours ago
Associate Director, Clinical Affairs
USA CA - Irvine Laguna Canyon
Full-time
Onsite
Lead/Staff, Director/Executive
$170K/yr - $280K/yr
10+ years expBD is one of the largest global medical technology companies in the world. The Associate Director of Clinical Affairs will manage senior managers and oversee multiple projects, ensuring compliance with regulatory requirements and successful completion of clinical studies.
Health CareMedical DeviceTechnical Support
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
Qualification
Required
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
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
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
Benefits
A valuable, competitive package of compensation and benefits programs
Rewards and recognition opportunities that promote a performance-based culture
Company
BD helps advance clinical therapy with the process for patients and health care providers with innovative technology services and solutions.
10001+ employees
H1B Sponsorship
BD has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (66)
2022 (4)
2021 (3)
Funding
Current Stage
Public CompanyTotal Funding
$540MKey Investors
Steris
2023-08-02Post Ipo Equity· $540M
1962-04-23IPO
Leadership Team
Tom Polen
Chairman, CEO and President
Richard Byrd
Executive Vice President and President Interventional Segment
Recent News
2026-01-22
Medical Device Network
2026-01-22
Company data provided by crunchbase