Clinical Strategy Lead

Convatec • Atlanta, MA

10d • Remote

About The Position

Our successful Clinical Strategy Lead will be involved in all aspects of Clinical & Medical Affairs that focus on evidence generation and strategy development for Advanced Wound Care medical devices. The role is varied and incorporates multiple activities, such as designing and executing clinical study protocols, planning of evidence generation strategies, retrospective analyses and in-market product support, generation of publications, and identification of unmet needs in the field. You will have close liaison with Clinical Operations, Global Education, Regulatory, Quality, Marketing & Business Development, and R&D colleagues. You will also build relationships with key opinion leaders and healthcare providers relevant to the product. This is a remote role with quarterly travel to the Boston, MA area.

Requirements

• Bachelor’s degree or higher degree in Medicine, Life Sciences, Allied Health, Pharmacy, or Nursing.
• 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.
• 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.
• Is able to make decisions and accept accountability.
• Willingly embraces change and the need to adapt to new circumstances.
• Takes an innovative approach while maintaining compliance.
• Effective use of oral and written communication skills to influence, inform or guide others.
• Ability to communicate fluently in English.

Nice To Haves

• Advanced degree (MD, PhD MSN, DNP) preferred.
• Clinical experience or specialty knowledge in wound care preferred.
• Experience in a medical device, pharmaceutical, or academic setting is a plus.
• Experience with regulatory requirements for clinical studies in the US and EU is highly desirable.

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.

Benefits

• retirement savings plan with company match
• paid vacation
• holidays
• community service days
• sick time
• paid caregiver/parental leave
• medical leave
• health benefits for individuals, families, and domestic partners, including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Senior