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VP Global Clinical Strategy Sports Medicine & ENT

Company: Smith & Nephew
Location: Andover
Posted on: June 12, 2021

Job Description:

The VP of Global Clinical Strategy (GCS) for the Sports Medicine and ENT (SPMENT) will be responsible to create and execute plans to collect clinical and economic evidence that expedites introduction of new products globally, expands adoption of products and secures continued access of approved products in compliance with regulations. The VP of GCS will work closely with surgeons, healthcare providers, and regulators as well as global internal stakeholders including the Franchise President, Marketing, Regional/Cluster Commercial leaders, R&D, Regulatory Affairs, and Clinical Operations (GCO).

This person will report directly to the Head of Global Clinical and Medical Affairs (GCMA) and represent GCMA on the Sports Medicine & ENT franchise leadership team, ensuring visibility and alignment of clinical affairs with franchise priorities. As a member of the SPMENT New Product Development Review Committee (NRC), this person will ensure timely development of global evidence strategy to support regulatory approvals. This person will also oversee timely evidence generation to support EU MDR (European Union Medical Device Regulations) compliance in a sustainable and efficient manner.

In summary, the person in this role will be the architect of clinical strategies for the SPMENT franchise, and will deliver business value in partnership with both internal and external stakeholders. This leadership role is a highly visible and influential role and will require strategic thinking, business acumen, and exceptional communication and partnership skills to be effective.

Essential Functions:

  • Serve as a member of the Franchise leadership team, ensuring visibility and alignment of clinical affairs with franchise priorities.

  • Partner with global and regional marketing, regulatory, market access and external stakeholders, and create evidence strategies to generate clinical and health economic evidence to expedite market access and expand market adoption for Smith + Nephew SPMENT products and technologies.

  • Serve as a member of the New Product Development Committee (NRC) for SPMENT and ensure timely development of global evidence strategy to support regulatory approvals.

  • Oversee global evidence generation plan development and execution via close interaction with global clinical operations, medical affairs and evidence evaluation to ensure on-time delivery of impactful evidence and effective dissemination on all key products/technologies.

  • Drive the development and implementation of KPIs to drive 100% alignment with business needs and business growth plan globally.

  • Oversee the development and implementation of strategic engagement and partnership in research with KOLs and research centers to drive quality improvement of clinical research.

  • Responsible for review and approval of clinical research projects following applicable of SOPs and compliance requirements.

  • Responsible for sustainable and efficient evidence generation to ensure MDR readiness Manage a team of global clinical strategy specialists for SPMENT. Responsible for team member's career development

Experience

  • 10+ years' experience (including 5+ years people management/leadership experience) in relevant fields (clinical, regulatory, market access, marketing, R&D) closely involved in clinical and health economic evidence strategy development for medical devices.
  • Knowledge and hands-on experience in designing and executing clinical studies.
  • Experience in developing and implementing clinical evidence strategies to support regulatory approvals in various markets is preferred
  • Experience in interacting with regulators (e.g. FDA, Notified body etc.) and other policy makers.
  • Knowledge and experience in review and assessment of scientific publications

Competencies

  • Exceptional communication skills and ability to collaborate exceptionally well in the matrix
  • Strong business acumen
  • Ability to see the big picture, and act as the chief architect of the clinical strategy for SPMENT franchise
  • Create a high performance team
  • Results-focused
  • Knowledge of the SPMENT business and customer stakeholders
  • Knowledge of national and international industry standards and best practices in clinical safety handling processes, US Code of Federal Regulations, ISO 14155, ICH GCP, ISO 14971, MDR experienced

Supervision

  • Clinical strategy team in SPMENT (6-10 team members)

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.

Veterans are strongly encouraged to apply.

Keywords: Smith & Nephew, Boston , VP Global Clinical Strategy Sports Medicine & ENT, Other , Andover, Massachusetts

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