Clinical Strategy Lead

This is a fully remote position, open to applicants in United Kingdom.

📋 Description

• Serve as a clinical strategist for the Advanced Wound Care Medical and Clinical Affairs team, concentrating on emerging technologies.

• Oversee the design of clinical studies, encompassing regulatory approvals, statistical analysis plans, and budget management.

• Collaborate with Medical Education, Key Opinion Leader Management, Business Development, Marketing, and regulatory teams.

• Engage with key opinion leaders, healthcare providers, and regulatory entities to pinpoint unmet needs.

• Convert business strategies into executable clinical study protocols and retrospective data generation plans.

• Evaluate clinical study and evidence-generation data, synthesizing findings into cohesive narratives.

• Create publications and evidence communications in collaboration with the medical writing team.

• Provide education and serve as a role model for colleagues beyond Medical Affairs.

• Assist in new product development, evidence generation and review, risk management, and various medical affairs activities.

• Function as a subject matter expert for the product line.

• Travel up to 20% overnight, which may include some international travel.

⛳️ Requirements

• Expertise in life sciences, medicine, or nursing.

• A Bachelor’s degree or higher in Medicine, Life Sciences, Allied Health, Pharmacy, or Nursing.

• A clinical background (MD, RN, DPM, DNP, or similar) is mandatory.

• Minimum of 3 years’ experience in the medical device or pharmaceutical sector, holding increasingly responsible roles.

• Comprehensive understanding of clinical research, including literature reviews, protocol development, overall study execution, and statistical analysis.

• Experience in clinical study design within an industry or academic context.

• Familiarity with the medical device industry, including product development, pre-clinical, clinical, quality, marketing, and regulatory aspects.

• Experience with regulatory requirements for clinical studies in both the US and EU is highly preferred.

• Strong computer skills with advanced proficiency in Microsoft Office.

• Demonstrated analytical and problem-solving abilities.

• Strong documentation practices.

• Exceptional written and verbal communication skills in English.

• Capability to communicate fluently in English.

• Ability to work independently as well as collaboratively as part of a team.

• Aptitude for decision-making and accepting accountability.

• Openness to embrace change and adapt to new conditions.

• Capacity to achieve results within timelines in a fast-paced environment.

🏝️ Benefits

• Retirement savings plan with a company match.

• Paid vacation.

• Paid holidays.

• Community service days.

• Sick time.

• Paid caregiver/parental leave.

• Medical leave.

• Medical coverage.

• Prescription drug coverage.

• Dental coverage.

• Vision coverage.

• Health benefits for individuals, families, and domestic partners.