Global Clinical Strategy Lead

4 months ago

Hull, United Kingdom Smith+Nephew Full time

Life Unlimited. At Smith+Nephew, we craft and manufacture technology that takes the limits off living

To help us maintain this, we’re looking for a Global Clinical Strategy Lead to ensure clinical activities align with business needs. Working within our Advanced Wound Management franchise; a creative and innovative mind is required to think of and deliver out of the box solutions to evidence gathering.

You will act as the principal Medical Device Regulation (MDR) Clinical Strategy representative for our Advanced Wound Care franchise, leading and coordinating our MDR clinical strategies, ensuring MDR readiness for new product registrations as well as ensuring MDR compliance of our existing product portfolio. Together we will provide continuing support for our products to access global markets and make a difference to patients’ lives.

This person will also represent clinical affairs throughout the AWM New Product Development (NPD) process, identifying customer and evidence needs and developing clinical evidence plans for all intended markets. In doing so we can bring products to markets that truly add new value to customers and patients and do so faster.

What will you be doing?

Create and execute a wide range of clinical evidence strategies for new product launches, market expansions, and existing product requirements. Work closely with other GCS leads to ensure new products registering in the EU for the first time meet the requirements for MDR upon submission to notified bodies, ensuring PMCF plans are in place for the lifetime of the product on the market and are reviewed on a periodic basis for the need to conduct additional PMCF activities based on changes to the risk benefit profile. Collaborate with NPD teams to offer wound care and clinical evidence expertise, ensuring our innovations meet customer needs and support regulatory approvals in all intended markets. Oversee and complete Post Market Clinical Follow-Up (PMCF) activities to meet MDR submission deadlines and audit readiness. Work with marketing, regulatory, market access, HEOR and other internal and external partners to create clinical and economic evidence. Assist teams in developing partnerships with Key Opinion Leaders and research centres to generate best-in-class evidence.

What does success look like?

Our successful candidate will be educated in a relevant discipline such as Science, Medical/Nursing or Engineering, as well as having a strong working background in medical devices within a Clinical Research, Scientific, Medical Affairs, Evidence Evaluations or Regulatory role where they were closely involved in clinical evidence strategy development or registration submission of medical devices in multiple geographies.

In addition, you’d ideally possess a wealth of experience with MDR submissions or documentation maintenance for medical devices and clinical study design and development, with knowledge and experience of woundcare practice/therapies and disease aetiologies being highly advantageous also.

You. Unlimited

165 years of groundbreaking innovation requires a steadfast focus on what’s next. We’re passionate about you. You’re what’s next...

Inclusion, Diversity and Equity: Committed to Welcoming, Celebrating and Growing on Diversity, Learn more about our Employee Inclusion Groups on our website Your Future: Generous annual bonus and pension Schemes, Save As You Earn share options. Work/Life Balance: Flexible Vacation and Time Off, Paid Holidays and Paid Volunteering Hours, so we can give back to our communities Your Wellbeing: Private Health and Dental plans, Healthcare Cash Plans, Income Protection, Life Assurance and much more. Flexibility: Hybrid Working Model (For most professional roles). Training: Hands-On, Team-Customised, Mentorship. Extra Perks: Discounts on Gyms and fitness clubs, Salary Sacrifice Bicycle and Car Schemes and many other Employee discounts.

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