Director, Clinical Affairs

Baxter International Inc.

Director of Clinical Affairs at Baxter leading clinical strategies and research programs. Driving clinical planning and overseeing compliance, budget, and timelines in healthcare delivery.

Posted 6/7/2026full-timeSkaneateles • Illinois, Minnesota, New York • 🇺🇸 United StatesLead💰 $208,000 - $286,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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

Benefits

Comp & perks

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
educational assistance programs
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
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical operationsclinical researchprotocol designdata collection standardsproject managementregulatory complianceclinical study executionproduct development processsoftware validationmonitoring reports

Soft Skills

leadershipcollaborationorganizational skillsproblem-solvingteam leadershipcommunicationdirection providingperformance monitoringresource managementbusiness prioritization

Certifications

BA/BS in scientific disciplineICH/GCP certificationISO 14155 certificationFDA regulatory knowledgeEuropean Regulatory Authority knowledge