Director, Clinical Affairs

This is where
your work makes a difference.

At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

In this role, you will lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption. You will drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines. You will also provide leadership to the clinical affairs team, ensuring high‑quality study operations, safety oversight, and successful delivery of clinical evidence supporting Baxter’s global portfolio

Clinical Strategy Development

• Gather business priorities for both pre-market (approval) and post market (evidence) needs for clinical research.
• Engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources as required as inputs for priority needs and to advise the execution strategy.
• Develop strategy and make recommendations for approaches to meet goals for technology feasibility, product validation, claims substantiation or content supporting market adoption.

Conduct Clinical Research

• Responsible for the identification and management of necessary resources to successfully initiate and complete clinical trials. Lead Clinical Study Execution team(s) to develop clinical strategies (and project plan) to efficiently manage the project(s) and maintain regulatory compliance. This includes but is not limited to:
• Clinical Plan – Partner with the Medical Monitor, Regulatory Affairs and Commercial to prepare a clinical plan for each project. This includes preparing timelines and budgets for the clinical program.
• Clinical Trial Protocols – Facilitate preparation of protocols including study design, case report forms, study procedures. Develop and complete enrollment feasibility evaluations based on protocol synopsis. Draft informed consents based on study and regulatory requirements.
• Research Agreements and Study Budgets – Prepare research agreements and negotiate study budgets with sites.
• Lead third party CROs and Contractor relationships
• Coordinate with Medical Affairs to identify clinical investigators and assess suitability of study sites. Recognize and maintain strong business relationships with key opinion leaders.

Clinical Affairs Team Leadership

Lead team members, contractors, and deliver the following directly or by leading others:

• Work with Supply Team to order clinical supplies and ensure logistics plans are in place prior to study start.
• Train study staff on product usage, data collection and specific procedures.
• Plan and conduct investigator meetings.
• Perform Study initiation visits directly
• Manage clinical study monitoring resources for protocol and regulatory compliance including adverse event reporting and follow‑up. If services of a Contract Resource Organization (CRO) or Central Laboratory are used, this position will lead the process to select the CRO/Central Lab and establish the contract. This role involves managing the day‑to‑day oversight of the CRO personnel plus the project budget, deliverables, and timeline/achievements.
• Develop and maintain tracking systems as needed for study management, e.g. screening, enrollment, study completion, (serious) adverse events, budgets and forecasts, achievements.
• Ensure the safety monitoring plan/safety tables have been agreed to by Medial Monitor and Vigilance/Surveillance functions are appropriate.
• Colla…