There's nothing more important than our physical health or more frightening than when something happens to it, holds the body back, puts life on pause, pulls us away from what we love and, brings our minds down with it. At some point it will happen to all of us; we can't stop it but we can stand-up to it. So at Smith & Nephew we have a promise; two words that inspire all we do, Life Unlimited. It's our commitment to use technology to take limits off living whether that's in wound, sports medicine or orthopaedics. Our purpose of Life Unlimited is driven by our cultural pillars of Care, Collaboration, and Courage! Smith & Nephew is more than just a leading global medical technologies organization. It's a world full of opportunities for you to grow expertly, develop personally, and make a lasting contribution to the health of people around the world! Are you ready to join us?
The Director of Global Clinical Strategy will lead the development and execution of clinical and economic evidence strategies for new product introduction globally, expanded adoption of products and securing continued access of approved products. This role will support the rapid generation of clinical and economic evidence by leveraging and developing strategic partnerships both locally and globally, utilizing the most appropriate methodologies and tools for generating evidence, and working closely with Commercial and Regulatory stakeholders to ensure clinical activities and priorities are aligned to key business needs for the Sports Medicine business franchise.
Will work closely with internal partners including Global Clinical Operations (GCO), Data Analytics, Evidence Evaluation (EE) and Medical Affairs and partners in R&D, Regulatory Affairs, Health Economics /Outcomes Research (HEOR), Marketing and Sales along with external customers, health care practitioners (HCPs) and key opinion leaders (KOLs)/early adopters to generate evidence on the impact of S&N products. Partner with external consultants and vendors to drive evidence generation activities.
The successful candidate will need insight into evidence requirements across the US and international markets, and be successful in development of strategies to identify and collect evidence to meet strategic business objectives. Candidates will also require knowledge of the methods for development of clinical and economic evidence. Reporting to the VP Global Clinical Strategy Sports Medicine/ENT, this role will lead clinical strategy and advise specialists or first line managers across several projects.
Responsibilities:- Responsible for crafting and driving high impact pivotal initiatives. Partner with Global and Regional Marketing, Regulatory, Market Access and external partners, and build evidence strategies including claims, publication strategy and conference submissions to generate clinical and health economic evidence to expedite market access and expand market adoption for Smith + Nephew products in the Sports Medicine franchise
- Serve on new product development teams for the Sports Medicine Franchise to ensure timely evidence strategy development and execution, as well as clinical support for regulatory submissions to support regulatory approvals of the product in key markets where applicable
- Develop global evidence generation plans via close partnership with Global Clinical Operations, Medical Affairs and Evidence Evaluation to ensure robust and feasible plans are in place and to ensure timely execution for key products/technologies to meet business needs. Responsible for the design of sophisticated randomized controlled trials providing strategic study design mentorship to junior clinical strategy personnel
- Develop clinical strategies to ensure MDR readiness and compliance, working closely with Global Clinical and Medical Affairs functions to align on evidence sufficiency. Drive and lead execution of PMCF activities and timely reporting in order to remain on schedule for MDR technical file submissions, Notified Body commitments, and audit readiness
- Support the development and implementation of strategic engagement and partnership in research with KOLs and research centers
- Responsible for ensuring support for Global Clinical Operations, as needed, in training investigators, research coordinators, Contract Research Organizations (CROs), central laboratories, and other study vendors on methodological study procedures
- May participate in internal/external Global Clinical Strategy-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary
Education: BA or equivalent required; Advanced degree (PharmD, PhD, PT, MPH, MS) in Science, Engineering or Medical strongly preferred, ideally in a relevant discipline.
Experience:- 10 years of proven experience ideally in the med-tech industry. Experience in sports medicine or orthopedics would be helpful.
- A track record of evidence generation and value communication, including clinical trial design, implementation of observational studies, in market clinical evaluations, and real-world data collection activities is preferred
- Experience in developing and implementing clinical evidence strategies to support regulatory approvals in various markets is helpful
- Experience leading people
- Knowledge and experience in the critical appraisal of published literature, as well as development of publications for peer-reviewed journals
- Familiarity with US health care system and reimbursement methodologies and experience in interacting with regulators (e.g. FDA, Notified Body etc.) and other policy makers are preferred
- Ability to work flexibly to meet ambitious timelines to address short-term requirements of the business, such as input to due diligence
Competencies:- Strong eye for business with an ability to develop strategies to meet business needs and priorities
- Capable of running multiple projects and adapting to changing needs of the business
- Expertise in the regulations and principles of clinical regulation
- Excellent interpersonal and communication skills
- Ability to work independently with limited supervision
- Ability to collaborate and influence across a matrix structure, reporting to cross functional internal partners
- Self-motivated
- Team-focused
- Results-focused
Location: Andover, MA preferred or Austin, TX or Field / Remote
Travel: up to 25% within the US region and occasional travel to international markets
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.