The Vice President of Global Clinical Strategy (VP of GCS) for the Orthopedics franchise will be responsible to create and execute plans to collect clinical and economic evidence that expedites the 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 Orthopedics Franchise President & Leadership, Marketing, Regional/Cluster Commercial leaders, R&D, Regulatory Affairs, and Clinical Operations (GCO).
This person will report directly to the Senior VP of Global Clinical and Medical Affairs (GCMA) and represent GCMA on the Orthopedics franchise leadership team, ensuring visibility and alignment of Clinical Affairs with Franchise priorities. As a member of the Orthopedics New Product Development Review Committee (NRC), this person will ensure timely development of global evidence strategy to expedite market access and 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 Orthopedics 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. The person in this role will be responsible for leading and developing a team dedicated to global clinical strategy for the Orthopedics franchise.
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 Orthopedics products and technologies.
Serve as a member of the New Product Development Committee (NRC) for Orthopedics 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 professionals for Orthopedics; responsible for team member's career development
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.
Smith & Nephew