Associate Director, Clinical Affairs

Becton Dickinson; Milpitas (CA); On-site; USD 184,000 - 294,000; Full time

Job summary

Waters Biosciences seeks an Associate Director of Clinical Affairs to lead global clinical operations, shaping study execution and evidence generation. You will manage a small, global team, collaborate across Medical Affairs, Regulatory, R&D, and Quality, and ensure timely delivery within budgets and high quality standards.

Ideal candidates will have 10+ years in clinical research/operations with leadership and deep regulatory knowledge, particularly in IVD, genomics, and proteomics contexts,

Qualifications

• Bachelor's degree in life sciences or related field.
• 10+ years in clinical research, clinical operations, or clinical affairs with leadership responsibilities.
• Proven track record delivering global or multi-center studies through teams, CROs, and cross-functional partners.
• Experience managing Clinical Project Managers and Clinical Research Associates/Monitors.
• Experience generating medical evidence for regulatory, post‑market, and reimbursement objectives.
• Strong FDA/ICH-GCP/ISO 14155 knowledge and global clinical regulations.
• Ability to review data and make informed decisions in diagnostic contexts.
• Experience overseeing CROs, sites, labs, and external vendors for studies.

Responsibilities

• Lead planning, execution, monitoring, and closeout of global clinical studies.
• Provide strategy for study management, monitoring, enrollment, site management, and risk mitigation.
• Contribute to study design, feasibility, enrollment strategies, and execution plans.
• Direct and manage CROs, sites, investigators, and labs for quality and timing.
• Oversee study budgets, contracts, and resource allocation across programs.
• Develop dashboards and KPIs to track progress and risks.
• Mentor a global team of Clinical Project Managers and CRAs/Monitors.
• Collaborate with Medical Affairs, Regulatory, R&D, and Quality on evidence plans.
• Support regulatory submissions and scientific communications with operational input.
• Drive continuous improvement including AI-enabled solutions for efficiency.

Skills

Leadership

Clinical operations

Budget management

Vendor management

Regulatory knowledge

Communication

Strategic thinking

Team development

Education

Bachelor's degree in life sciences

Tools

SOPs

GxP

Job description

As a result of the combination of the BD Biosciences and Diagnostic Solutions business with Waters Corporation (NYSE: WAT), by applying to this role, you will be applying for a position with Waters. Waters is a global leader in life sciences, dedicated to accelerating the benefits of pioneering science through analytical technologies, informatics, and service. With a focus on regulated, high-volume testing environments, Waters’ innovative portfolio harnesses deep scientific expertise across biology, chemistry, and physics. Waters collaborates with analytical laboratories around the world to advance the release of effective, high-quality medicines, assure the safety of food and water, and drive better patient outcomes by detecting diseases earlier, managing routine infections, and combatting growing antibiotic resistance. Through a shared culture of relentless innovation, Waters’ passionate team of approximately 16,000 colleagues partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide. We are the people who give possibilities purpose 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.

Job Description

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.

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.

Minimum Requirements

• Education: Bachelor's degree in a scientific discipline or related field (life sciences, biology, chemistry, or similar)
• Experience Level: Minimum 10 years of clinical research, clinical operations, or clinical affairs experience with substantial responsibility for clinical study execution, study management, and monitoring oversight
• Study Delivery Track Record: 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
• Leadership Experience: 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
• Evidence Generation Experience: Experience supporting global medical evidence-generation programs for new and existing products, including regulatory, post-market, and reimbursement-related objectives
• Regulatory Knowledge: Strong working knowledge of FDA regulations, ICH-GCP, ISO 14155, human subject protection requirements, and global clinical research regulations
• Technical/Scientific Acumen: Demonstrated ability to review and evaluate scientific, clinical, technical, and statistical data to support sound decision‑making in complex diagnostic or life science contexts
• Vendor Management: 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
• Industry‑Specific Experience: 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
• Regulatory Submissions: Experience providing clinical study execution expertise to support development of clinical study reports, regulatory submissions, and scientific communications
• Budget & Portfolio Management: Experience managing study budgets, contract negotiations, vendor engagements, resource allocation, and portfolio-level performance metrics with demonstrated prioritization skills
• Process Improvement: 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
• Cross‑Functional Collaboration: Experience partnering with Medical Affairs, Regulatory Affairs, R&D, Quality, Data Management, and other stakeholders in a product development environment
• Communication Skills: Excellent written, verbal, and presentation skills with demonstrated ability to influence cross‑functional stakeholders in a highly matrixed environment
• Travel: Ability to travel domestically and internationally up to 15% Preferred

Preferred Qualifications

• Advanced Education: Advanced degree such as MS, PhD, MD, PharmD, or equivalent in a relevant scientific or clinical discipline
• Professional Certification: SOCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) certification

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?

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 healthcare. At BD, you’ll discover a culture in which you can learn, grow and thrive. We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face‑to‑face collaboration supports your learning, your progress, and your success. To learn more about BD visit https://bd.com/careers. Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.

Becton, Dickinson and Company is an Equal Opportunity Employer.

Required Skills Optional Skills . Primary Work Location USA CA - Milpitas 135 Additional Locations Work Shift At BD, we reward, support and develop our associates through our comprehensive Total Rewards program. We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance‑based culture, as well as a competitive package of compensation and benefits programs. You can learn more on our career site under "Our Commitment to You." Our salary or hourly rate ranges reward associates fairly and competitively. We regularly review these ranges and factors, such as location, contribute to the range displayed. Our pay is based on the role and the necessary skills and education to perform it successfully. The salary or hourly rate offered is determined by the role's specific requirements, including any applicable step rate pay system at the work location. Salary or hourly pay ranges are influenced by labor laws and Collective Bargaining Agreement (CBA) requirements applicable to the work location which may also affect the workplace arrangement of the role. Salary Range Information $183,800.00 - $294,100.00 USD Annual We are the #MakersofPossible Working together, we make products that patients, families and their healthcare professionals rely on. We do this because we are committed to advancing the world of health™. But it takes the imagination and passion of all of us at BD, from manufacturing to marketing, to look at the impossible and find solutions that turn dreams into possibilities with real-life health benefits for people today, tomorrow and beyond. We make this happen, together. We are the makers of possible. Becton, Dickinson and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.