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

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.

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

Director, Clinical Affairs

Key skills