Key skills
Statistical AnalysisRisk ManagementCommunicationCollaboration
About this role
Role Overview
- Act as a clinical strategist for Advanced Wound Care Medical and Clinical Affairs team
- Play a lead role in clinical study design, including regulatory approvals, statistical analysis plan, and budget
- Close collaboration with Global Medical Education and Key Opinion Leader Management colleagues and Business Development and Marketing teams
- Work closely with the clinical operations colleagues to translate business strategies to actionable clinical study protocols and retrospective data generation plans
- Analyze data output from clinical studies and other evidence generation activities
- Play a proactive role in putting together publications and evidence communication in close collaboration with the medical writing team
- Act as an educator and role model for colleagues outside of medical affairs
- Support all general medical affairs activities, including new product development, evidence generation and review, risk management
Requirements
- Bachelor's degree or higher degree in Medicine, Life Sciences, Allied Health, Pharmacy, or Nursing
- Advanced degree (MD, PhD MSN, DNP) preferred
- Clinical experience or specialty knowledge in wound care preferred
- At least 3 years’ experience in the medical device or pharmaceutical industry in positions of increasing responsibility
- Strong understanding of clinical research, including literature reviews, protocol development, general study execution, and statistical analysis
- Experience in clinical study design in an industry or academic setting
- Understanding of the medical device industry: product development, pre-clinical, clinical, quality, marketing, and regulatory components
- Experience with regulatory requirements for clinical studies in the US and EU is highly desirable
- Strong computer skills
- High level of proficiency of Microsoft Office
- Ability to communicate fluently in English
Benefits
- retirement savings plan with company match
- paid vacation
- paid holidays
- community service days
- sick time
- paid caregiver/parental leave
- medical leave
- health benefits for individuals, families, and domestic partners (medical, prescription drug, dental, vision)