Associate Director, Clinical Affairs

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

Job summary

BD recognizes the strategic value of clinical evidence and seeks an Associate Director, Clinical Affairs to lead global operations for Waters Biosciences. The role oversees clinical studies, collaborates with Regulatory, R&D, and Quality, and drives performance metrics.

A strong background in IVD/ genomics and leadership is essential to advance regulatory objectives and evidence generation. Top candidates will mentor a global team and work across divisions to optimize execution, budgets, and CRO

Qualifications

• Bachelor's degree in life sciences or related field is required.
• Minimum 10 years in clinical research, operations, or affairs with global scope.
• Experience with IVD, molecular diagnostics, genomics or proteomics is highly desirable.

Responsibilities

• Lead global clinical studies from start-up to closeout with timelines and budgets.
• Provide oversight of study management, monitoring, enrollment, and site management.
• Manage CROs, labs, investigators and external vendors for quality and timeliness.
• Develop dashboards and KPIs to track progress, risk, and performance.
• Mentor and develop a global Clinical Project Manager team and CRAs/Monitors.

Skills

Clinical operations

Leadership

Regulatory knowledge

Study management

Vendor management

Cross-functional collaboration

Biotech/Medtech experience

Education

Bachelor's degree in life sciences

Tools

Statistical analysis

Job description

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 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.

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.

Required Skills

Optional Skills

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Primary Work Location

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