Associate Director, Clinical Affairs

Becton Dickinson Medical Devices•Milpitas, CA

3d•Hybrid

About The Position

The Associate Director, Clinical Affairs reports to the Senior Director, Medical Affairs and leads Clinical Affairs operations globally for the Waters Biosciences business. This individual is accountable for the successful execution of clinical studies supporting product development, regulatory objectives, and evidence generation activities. Experience supporting in vitro diagnostics (IVD), molecular diagnostics, genomics, proteomics, or related technologies is highly desirable. The role includes management of a small global team of Clinical Project Managers and Clinical Research Associates/Monitors and serves as a key leader for clinical study execution across the organization.

Requirements

Bachelor's degree in a scientific discipline or related field (life sciences, biology, chemistry, or similar)
Minimum 10 years of clinical research, clinical operations, or clinical affairs experience with substantial responsibility for clinical study execution, study management, and monitoring oversight
Proven success overseeing and delivering global or multi-center clinical studies through Clinical Project Managers, CROs, and cross-functional teams from study start-up through closeout
Demonstrated experience managing Clinical Project Managers, Clinical Research Associates/Monitors, or similar clinical operations professionals. With demonstrated leadership, mentoring, and talent development capabilities with a collaborative and results-oriented approach
Experience supporting global medical evidence-generation programs for new and existing products, including regulatory, post-market, and reimbursement-related objectives
Strong working knowledge of FDA regulations, ICH-GCP, ISO 14155, human subject protection requirements, and global clinical research regulations
Demonstrated ability to review and evaluate scientific, clinical, technical, and statistical data to support sound decision-making in complex diagnostic or life science contexts
Proven experience managing CROs, investigative sites, laboratories, and other external vendors, including study start-up, enrollment management, monitoring oversight, protocol compliance, issue resolution, and clinical quality management
Experience supporting clinical studies for in vitro diagnostics (IVD), molecular diagnostics, genomics, proteomics, life science research tools, or related technologies—this is particularly important given the Waters Biosciences business focus
Experience providing clinical study execution expertise to support development of clinical study reports, regulatory submissions, and scientific communications
Experience managing study budgets, contract negotiations, vendor engagements, resource allocation, and portfolio-level performance metrics with demonstrated prioritization skills
Track record of driving continuous improvement of clinical operations processes, systems, and standards, including experience evaluating and implementing technology solutions (such as AI-enabled tools) to improve operational efficiency
Experience partnering with Medical Affairs, Regulatory Affairs, R&D, Quality, Data Management, and other stakeholders in a product development environment
Excellent written, verbal, and presentation skills with demonstrated ability to influence cross-functional stakeholders in a highly matrixed environment
Ability to travel domestically and internationally up to 15%

Nice To Haves

Advanced degree such as MS, PhD, MD, PharmD, or equivalent in a relevant scientific or clinical discipline
SOCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification
Experience supporting in vitro diagnostics (IVD), molecular diagnostics, genomics, proteomics, or related technologies is highly desirable.

Responsibilities

Accountable for the successful planning, execution, monitoring, and closeout of global clinical studies conducted by the Clinical Affairs team, ensuring delivery against timelines, budgets, quality standards, and business objectives.
Provide strategic oversight, guidance, and escalation support for clinical study execution, including study management, monitoring operations, enrollment performance, site management, investigator engagement, and risk mitigation activities.
Provide operational input into study design, protocol development, feasibility assessments, enrollment strategies, and execution planning.
Direct and hold accountable CROs, clinical sites, investigators, laboratories, and other external partners for quality, compliance, timelines, and deliverables.
Manage study budgets, contract negotiations, vendor engagements, resource allocation, and portfolio-level performance metrics, ensuring appropriate prioritization and resource utilization across clinical programs.
Establish and communicate study and portfolio-level dashboards and key performance indicators to ensure visibility into progress, risks, resource utilization, performance.
Lead, mentor, and develop a global team of Clinical Project Managers and Clinical Research Associates/Monitors, ensuring consistent application of clinical operations best practices and execution excellence.
Partner with Medical Affairs, Regulatory Affairs, R&D, Quality, Data Management, and other stakeholders to define and execute clinical research and evidence-generation plans aligned with business objectives.
Collaborate with cross-divisional Clinical Affairs teams regarding study supplies, database development, data management, statistical analysis, and HEOR activities.
Provide clinical study execution and evidence-generation expertise to Regulatory Affairs and support development of clinical study reports, regulatory submissions, and scientific communications.
Drive continuous improvement of Clinical Affairs processes, systems, and internal standards, including evaluation and implementation of AI-enabled solutions to improve operational efficiency and effectiveness.