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.

Medical Strategy & Leadership

• 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 postmarket evidence), HEOR needs, and marketing/valuecommunication 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.

Evidence Generation & Scientific Leadership (Clinical, RWE, HEOR)

• 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 management. Proven experience engaging with Notified Bodies and a clear understanding of their expectations regarding clinical evidence, benefit risk justification, and conformity assessment processes.

• Serve as a senior representative for FLC with KOLs, professional societies, advisory boards, and scientific conferences.
• Establish and govern a strategic KOL engagement plan, advisory board strategy, and key scientific messaging (non-promotional, evidence-based) for each of the business groups in FLC: Cardiology, Exam Diagnostics, Patient Monitoring and Respiratory Health
• Sponsor/oversee medical content and scientific communications (e.g., congress strategy, manuscripts, abstracts, scientific platforms) aligned with global evidence roadmap in accordance with policies.

• Build strong, trusted partnerships across R&D, Regulatory Affairs (RA), Quality, Marketing, Reimbursement, Regions, Market Access, , and Patient Safety to enable a highly effective, compliant operating environment.
• Provide medical input into labeling, risk/benefit narratives, regulatory submissions support, and post-market commitments, as appropriate.
• Ensure adherence to global Medical Affairs standards, develop Medical /GCP policies, and processes as needed for FLC; reinforce a culture of ethics, compliance, and patient-centric decision-making.

• Partner with Global Patient Safety as a product/therapy to provide subject matter expert support through self or others enabling signal evaluation, benefit-risk assessment, and safety-related activities.
• Contribute to post-market surveillance strategy and cross-functional risk management reviews as required.

• Provide expert medical/scientific leadership for due diligence on business development opportunities (e.g., partnerships, acquisitions, licensing), including clinical risk assessment and evidence needs.

• Lead, coach, and develop a high-performing Medical Affairs team; ensure the organization has the competencies, capabilities, and talent needed to deliver on strategy across the entire product lifecycle and including organic and inorganic opportunities.
• Drive performance management, succession planning, and professional development.
• Own global Medical Affairs resource planning and budget management within scope of responsibility.

• 8-10+ years of industry experience, including meaningful experience in MedTech.
• 5+ years of strategic leadership/management experience, including people leadership in a matrixed environment.
• Demonstrated experience developing and implementing global evidence roadmaps. Leading/partnering on clinical evidence strategy, scientific communications, and cross-functional decision-making.
• Strong understanding of the U.S. and Global regulatory and healthcare environment including EuMDR and notified bodies requirements.
• Proven track record to operate with high integrity and in alignment with compliance standards.
• Demonstrate solid proficiency in study build, clinical trial methodology

• M.D. (Medical Doctor) with board-eligibility or board-certification (preferred areas include Cardiology, Internal Medicine).
• Experience supporting medical device product development from innovation to concept and through approvals/launches while leading all aspects of the ongoing management of complex medical technologies.
• Experience interacting with regulatory and/or legislative bodies, scientific societies, and external clinical leaders.
• Background in leading clinical development teams and experience in in HEOR/RWE activities (preferred) ,
• Background in partnering with Market Access, Regulatory, Quality and Patient Safety functions.

• Executive presence; ability to influence senior stakeholders and engage directly with customers.
• Strong business insight; comfort with ambiguity and complexity.
• Excellent communication skills-able to simplify and clearly convey complex scientific/clinical topics.
• Empathetic, motivating leadership style; builds trust and credibility quickly with a proven track record for leading diverse teams
• Track record of success in highly matrixed organizations; collaborative and dedicated to achieving results.
• Uncompromising ethics and commitment to patient safety and scientific integrity.

• U.S.-based preferred
• Ability to travel frequently domestically and occasionally internationally. If non-US based, minimum quarterly travel to US required.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $280,000 - $385,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter

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