Director, Clinical Affairs

Responsibilities

• Lead the development and execution of clinical strategies and research programs to drive product innovation and market adoption.
• Gather business priorities for pre-market approval and post-market evidence needs.
• Manage clinical study execution, including protocol design, study procedures, and enrollment feasibility.
• Oversee third-party CROs, contractors, and study site relationships.
• Lead the clinical affairs team in managing budgets, timelines, and regulatory compliance.
• Ensure safety monitoring, adverse event reporting, and data management plan implementation.
• Coordinate clinical supplies, investigator meetings, and study closeout procedures.

Requirements

• BA/BS in a scientific discipline.
• 10+ years of clinical operations experience in the pharmaceutical, biotechnology, or medical device industry (medical device preferred).
• Expertise in ICH/GCP, ISO 14155, and FDA/European Regulatory requirements.
• Extensive knowledge of the product development process (Phase 1 through Phase 4) for medical device trials.
• Proficiency with clinical operations systems including EDC, CTMS, and eTMF.
• Expertise in regulatory submission procedures such as NDA, CTD, and IDE.
• Strong project management and team leadership skills.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, and disability.
• 401(k) Retirement Savings Plan with company matching.
• Employee Stock Purchase Plan (ESPP).
• Paid time off ranging from 20 to 35 days based on service.
• Paid parental leave and family medical leave.
• Educational assistance programs and childcare benefits.

About the Company

Baxter is a global healthcare leader dedicated to a mission to Save and Sustain Lives. Since 1931, we have been at the forefront of innovation, redefining healthcare delivery to make a greater impact on patients around the world. We foster a culture of courage, trust, and collaboration where every individual is empowered to make a meaningful impact.