Senior Specialist, Global Clinical Strategy - Sports Medicine Biologics (Andover, MA)

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

The purpose of this role is for the design and execution of clinical and economic evidence to support business strategies for new product development, expanded product adoption, and securing global access for approved products. This role will support the Sports Medicine Biologics business.

This position works closely with internal partners including Global Clinical Research Operations (GCRO), Global Data Analytics, Evidence Evaluation (EE), Evidence Analysis (EA), Regulatory Affairs, Health Economics/Outcomes Research, Global Marketing and Biologic Sales Teams. Externally, this position works closely with health care practitioners, consultants and vendors to drive evidence generation activities.

What will you be doing?

• NPD (10%) – Serve or assist on new product development teams for Sports Medicine Biologics and provide clinical support for required regulatory submissions. This includes liaising with cross-functional teams (i.e., EE, EA, Regulatory) to assess evidence needs and ensure timely evidence strategy execution.

• Secure/Maintain Access (40%) – Perform robust and objective review of clinical and scientific data to support product maintenance for EU MDR requirements in relation to PMCF plans and PSURs. This includes relevant study oversight, on time delivery of relevant study milestones, and the generation of clinical activity reports, if applicable.

• Support Market Adoption (50%) – Manage evidence generation opportunities from clinical project approval to evidence activation (i.e. Sponsor Initiated Studies, Investigator Initiated Studies, Data Collection Agreements) to support the evidence needs as part of the business priorities. This includes building strong working relationship within Global Clinical and Medical Affair Teams, Global Marketing and other business functions to support identification, evaluation and communication of data and evidence to support health care professional evidence-based decision making. Managing multiple projects and adapting to changing needs of the business and stake holders.

What will you need to be successful?

• Education: BS in engineering, or Life Sciences with 4+ years of experience. MS in engineering or life sciences in a related field + 2 years or PhD in engineering or life sciences in a related field

• Experience: 2+ years of experience conducting or designing clinical research

• Experience in sports medicine or orthopedics would be advantageous

• Experience in developing and implementing clinical evidence strategies to support regulatory approvals in various markets is preferred

• Knowledge and experience in the critical appraisal of published literature, as well as development of manuscripts for peer-reviewed journals

• Travel Requirements: up to 10% domestic and or international

You. Unlimited

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients 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.