Note: The job is a remote job and is open to candidates in USA. Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions. The Clinical Strategy Lead will be involved in all aspects of Clinical & Medical Affairs focusing on evidence generation and strategy development for Advanced Wound Care medical devices.
Responsibilities
- Act as a clinical strategist for our Advanced Wound Care Medical and Clinical Affairs team, with a special focus on emerging Advanced Wound Care technologies
- 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 through interactions with key opinion leaders, healthcare providers, and regulatory bodies to analyze and identify unmet needs in our field
- 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 and distill these into a cohesive “story” to be presented when needed
- 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 our general medical affairs activities, including, but not limited to new product development, evidence generation and review, risk management, and other activities as needed
- Act as a subject matter expert in the product line
Skills
- Bachelor's degree or higher degree in Medicine, Life Sciences, Allied Health, Pharmacy, or Nursing
- Clinical background (MD, RN, DPM, DNP, or similar) required
- 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
- A proven ability to deliver results according to timelines in a dynamic environment
- Strong computer skills and high level of proficiency of Microsoft Office
- Works both as a team member and independently, engages and supports other members of the team and willingly accepts support when required
- Willingly embraces change and the need to adapt to new circumstances
- Effective use of oral and written communication skills to influence, inform or guide others
- Ability to communicate fluently in English
- Advanced degree (MD, PhD MSN, DNP) preferred
- Specialty knowledge in wound care preferred
Benefits
- Performance-based incentive compensation, which could include participation in an annual incentive program or a sales incentive plan
- A comprehensive benefits package, which includes a retirement savings plan with company match
- Time off to include: paid vacation, holidays, community service days, sick time, paid caregiver/parental leave and medical leave
- Health benefits for individuals, families, and domestic partners, including medical, prescription drug, dental, and vision coverage, in accordance with the terms of the applicable plans
Company Overview