Sr. Director, Medical Affairs

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Senior Director, Global Medical Affairs – Front Line Care (FLC) is the senior medical leader responsible for shaping and delivering the Global Medical Affairs vision, strategy, and operating plan for FLC products and therapies. This leader serves as a strategic partner to the FLC division marketing, research and development, reimbursement, and cross‑functional collaborators to ensure Medical Affairs enables business strategy while maintaining the highest standards of ethics, scientific rigor, and medical compliance.

The role leads the team providing strategic medical and clinical leadership into innovation, new product development (NPD), market adoption, and the product lifecycle. This individual is accountable for the development of robust clinical and real‑world evidence strategy and execution to support regulatory approvals, product launches, market adoption, and lifecycle management for FLC globally and acts as a primary scientific/clinical spokesperson externally and internally engaging with Key Opinion Leaders (KOLs), scientific congresses, advisory boards, and regulatory agencies.

• Define and implement the FLC Global Medical Affairs strategic plan and critical evidence priorities in collaboration with business partners. The Medical Affairs strategy must encompass a comprehensive evidence­generation roadmap that addresses regulatory requirements (incl. EU MDR clinical and post‑market evidence), HEOR needs, and marketing/value‑communication objectives.
• Provide senior medical leadership and decision support for business strategy, innovation, and new product development across the FLC portfolio and regions.
• Translate clinical, scientific, and customer insights into clear strategic recommendations and measurable execution plans; ensuring alignment across regulatory, HEOR, commercial, and clinical priorities to support product lifecycle success.
• Ensure strong expertise in study build, clinical trial methodology, and evidence‑generation guidelines, enabling robust clinical development strategies and high‑quality data to meet regulatory, clinical, and commercial expectations.

• Develop global clinical evidence roadmap enabling execution of the global business priorities. Lead the evidence‑generation strategy across the product lifecycle (pre‑launch through post‑market), including clinical evidence, and real‑world evidence (RWE). Accountable for publication and dissemination strategy for clinical evidence driving focus of downstream Medical Science Liaisons and regional commercial teams.
• Accountable for Baxter‑sponsored clinical research for FLC, ensuring scientific integrity and compliance with Good Clinical Practice (GCP) Oversight of scientific review of Investigator‑Initiated Research (IIR) and accountable for compliance in engaging and paying external investigators for research.
• Create appropriate partnerships internally and externally to develop health economics & outcomes research (HEOR) needs and execution for HEOR evidence.
• Develop and lead 3rd party relationships (e.g. CROs) as required to implement study deliverables.
• Demonstrated and in‑depth knowledge of the European Medical Device Regulation (EU MDR 2017/745), including requirements for technical documentation, clinical evaluation, PMS/PMCF, and risk…