Executive Director providing strategic leadership in device safety and product quality for a global health care leader. Ensures compliance, patient safety, and effective collaboration across various departments.
About the role
- Lead Clinical Affairs strategy and execution for product innovation at Baxter while driving clinical research and overseeing project compliance. Collaboration with cross-functional teams is essential.
Responsibilities
- lead the development and execution of clinical strategies and clinical research programs
- drive clinical planning, study execution, regulatory compliance, and cross-functional collaboration
- oversee CROs, study sites, budgets, and timelines
- provide leadership to the clinical affairs team
- gather business priorities for clinical research
- engage collaboratively with Medical Affairs, Marketing, Reimbursement, and R&D resources
- develop strategy and make recommendations
- identify and manage necessary resources for clinical trials
- lead clinical study execution team(s)
- prepare clinical plans for projects
- draft informed consents based on study and regulatory requirements
- negotiate study budgets with sites
- manage day-to-day oversight of CRO personnel
- collaborate with data management
Requirements
- 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
- 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
- Identifies new uses of current systems or use of new applications to enhance project management capabilities
- Expertise in clinical aspects of regulatory submission procedures, e.g. NDA, CTD, IDE
- Expertise in project management practices
- Exceptional organizational and team leadership skills.
Benefits
- medical and dental coverage starting day one
- insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
- Employee Stock Purchase Plan (ESPP)
- 401(k) Retirement Savings Plan (RSP)
- Flexible Spending Accounts
- educational assistance programs
- paid holidays
- paid time off ranging from 20 to 35 days based on length of service
- family and medical leaves of absence
- paid parental leave
- commuting benefits
- Employee Discount Program
- Employee Assistance Program (EAP)
- childcare benefits
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