Lead, Global Clinical Strategy, Sports Medicine (Andover, MA)

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

The Lead - Global Clinical Strategy, Sports Medicine will be the Global Clinical Strategy (GCS) representative for the franchise team, providing strategic clinical direction for the life cycle for products within the Sports Medicine portfolio. The Lead - Global Clinical Strategy, Sports Medicine primary responsibilities are to ensure the available clinical and health economic evidence for their portfolio of products meets internal and external requirements for new product introduction globally, expanded adoption of products and continued access of approved products.

The Lead - Global Clinical Strategy, Sports Medicine will work closely with internal Global Clinical & Medical Affairs (GCMA) functions, Market Access, Regulatory, R&D and Marketing partners and with external health care professionals.

What will you be doing?

• Apply a comprehensive understanding of S&N's commercial priorities in development of the clinical strategy for Sports Medicine portfolio products.

• Work with the New Product Development teams to establish user needs, claims, indications and market strategies, and develop the evidence generation strategies to meet those needs.

• Review clinical and health economic evidence and identify evidence gaps. This includes, but is not limited to, assessing the evidence available through published literature, registries, and unpublished clinical studies.

• Develop study proposals and initiate clinical activities to support evidence generation needs. Communicate with study investigators and study sites, as applicable, to process and track study proposals, budgets.

• Manage Sports Medicine Investigator Initiator Studies (IIS), collaborative research, and real-world data collection activities to ensure business objectives/processes and study milestones are met.

• Create, maintain, contribute to, and/or review Clinical Strategy-assigned documentation supporting the product lifecycle. This may include, but is not limited to, Post-Market Clinical Follow-up Plans, Clinical Development Plans, Clinical Evaluation Reports, Periodic Safety Update Reports, Product Claims Sheets, Risk Management Files, Clinical Benefit Effects Analyses and Instructions for Use.

• Review, analyze (as applicable), and document supporting data. Develop reports, as applicable, and ensure data/reports are provided to appropriate stakeholders, ensuring the format is appropriate for its intended use.

• Generate publication strategies

• Present progress and results to internal stakeholders

• May contribute to development or updates of department standard operating procedures (SOPs) and policies.

• Support regulatory documentation for new or existing products, as applicable. This may include development of responses for clinical-related questions received from regulatory authorities.

• Support both internal and external audits, as needed.

• Ensure compliance to applicable processes, quality standards and regulations.

• Attend professional conferences and surgeon training labs as appropriate.

What will you need to be successful?

• Education:

  • BS plus 6 years' experience or MS plus 3 years' experience or PhD plus 1 year experience.

• Experience:

  • Experience in engineering, design, scientific, clinical subject or related field.

  • Experience with medical device software solutions preferred.

• Experience in developing strategies to generate clinical evidence; Experience working with health care professionals to establish and manage clinical evidence generation activities.

• In-depth knowledge and experience in clinical research and methodology, experience in clinical study design is preferred.

• Knowledge of sports medicine surgical techniques is preferred.

• Travel Requirements: Up to 20%

You. Unlimited

We believe in creating thegreatest good for society. Our strongest investmentsare in our people and thepatients we serve.

Inclusion, Diversity and Equity- We are committed to welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ).

Other reasons why you will love it here!

• Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Options, Tuition Reimbursement
  Work/Life Balance: PTO, Paid Holidays, Flex Holidays, Paid Community Service Day

• Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program

• Flexibility: Hybrid Work Model (For most professional roles)

• Training: Hands-On, Team-Customized, Mentorship

• Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.