Director, Clinical Affairs

Responsibilities

• lead the development and execution of clinical strategies and clinical research programs that enable Baxter’s product innovation and market adoption
• drive clinical planning, study execution, regulatory compliance, and cross‑functional collaboration while overseeing CROs, study sites, budgets, and timelines
• 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
• gather business priorities for clinical research
• engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
• conduct clinical research and manage necessary resources to successfully initiate and complete clinical trials
• prepare clinical plan for each project including timelines and budgets
• lead clinical study execution team(s) to develop clinical strategies (and project plan)
• facilitate preparation of protocols including study design, case report forms, study procedures

• BA/BS in scientific discipline
• minimum of 10+ years clinical operations experience (pharmaceutical, biotechnology or medical device industry; medical device preferred)
• Expertise in ICH/GCP, ISO 14155, US Federal Food and Drug Administration and European Regulatory Authority requirements
• Well‑established knowledge in overall product development process from Phase 1 through Phase 4 for medical device trials, including software validation as required
• Possesses expert knowledge of research objectives, protocol design, and data collection standards
• Experience reviewing monitoring reports
• High experience/proficiency with clinical operations systems including EDC, CTMS, and eTMF
• Ability to monitor performance of team in maintaining system updates to allow for senior management reports
• Applies current applications/systems to compile information for presentation or distribution
• Identifies new uses of current systems or use of new applications to enhance the management capabilities of projects
• Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
• Expertise in project management practices
• Ability to provide positive direction to team as well as identify problems/issues and work towards resolution
• Exceptional organizational and team leadership skills

• clinical operations
• clinical research
• protocol design
• data collection standards
• project management
• regulatory compliance
• clinical study execution
• product development process
• software validation
• monitoring reports

• leadership
• collaboration
• organizational skills
• problem-solving
• team leadership
• communication
• direction providing
• performance monitoring
• resource management
• business prioritization

• BA/BS in scientific discipline
• ICH/GCP certification
• ISO 14155 certification
• FDA regulatory knowledge
• European Regulatory Authority knowledge