Senior Manager, Global Clinical Strategy

Smith & Nephew; Field (NM); Hybride; USD 126 000 - 188 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Pension schemes

Share options

Flexible vacation & holidays

Private health & dental plans

Income protection

Résumé du poste

Smith+Nephew is seeking a Senior Manager Global Clinical Strategy to lead the development and execution of clinical and health economic evidence strategies for market access and adoption of Knee Robotics products. You will collaborate with global teams, regulators, and external partners to align evidence with business needs and MDR readiness.

The role demands senior-level experience in orthopaedics, strong leadership, and the ability to drive PMCF activities, publications, and regulatory

Qualifications

• BS or MS in engineering, science, or related field with 7+ years of experience.
• Experience leading clinical/economic evidence strategies for market access.
• Orthopaedics background with MDR/Regulatory familiarity is valuable.

Responsabilités

• Lead development and execution of clinical and health economic evidence strategies.
• Partner with marketing, regulatory, market access, and external partners.
• Drive PMCF activities and MDR file submissions with timely reporting.
• Support regulatory documentation and responses to authorities as needed.
• Mentor and manage the Knee Robotics clinical team and resources.
• Present progress to stakeholders and update SOPs and processes.

Connaissances

Leadership

Orthopaedics experience

Clinical strategy

Evidence generation

Stakeholder management

Communication

Technical writing

MS Word

Excel

PowerPoint

Formation

Bachelor's degree in engineering/science

Master's degree (preferred)

Outils

Microsoft Word

Excel

PowerPoint

Description du poste

Life Unlimited. At Smith+Neb who craft and manufacture technology that takes the limits off living!

The Senior Manager Global Clinical Strategy will lead the development and execution of clinical and economic evidence strategies to support market access, new product development, increase market adoption and/or maintain registration. This role will support the Knee Robotics franchise within Orthopaedics. 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, market access and regulatory stakeholders to ensure clinical activities are optimized and aligned with key business needs for the Knee Robotics franchise.

What will you be doing?

Responsible for crafting and driving high impact pivotal initiatives across the Orthopaedics portfolio. 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 Knee Robotics franchise. Supports new product development teams for the Knee Robotics to ensure timely evidence strategy development and execution, as well as clinical support for regulatory submissions to support regulatory approvals of the products in key markets where applicable. Develops 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 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. Participation in internal/external Global Clinical Strategy-related audits, and regulatory inspections as needed; Implement appropriate corrective and preventative actions (CAPA), if necessary. Presents progress and results to internal stakeholders at all levels of the organization. Contributes to development or updates of department standard operating procedures (SOPs), business processes, 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. Ensure compliance to applicable processes, quality standards and regulations. Attend professional conferences and surgeon training labs as appropriate. Team Management, business needs gathering, stakeholder alignment, budget management and reporting. Oversight and direct support of Knee Robotics portfolio of clinical activities and deliverables, including external liaison with KOLs and clinical consultants.

What you need to be successful?

BS plus 7 years' experience or MS plus 3 years' experience. Experience in engineering, design, scientific, clinical subject or related field. At least 3 years' direct management experience. Experience in orthopaedics. Able to communicate complex concepts effectively. Experience in taking the initiative to negotiate and work closely with others; experience in building and executing evidence strategies for purposes of achieving product reimbursement. Experience presenting deep scientific topics to highly scientific and/or influential audiences; experience working across teams to solve ambiguity and drive to a decision point. Self-motivated and able to work independently, whilst maintaining inclusive approaches. Excellent time management skills and ability to work under pressure to deadlines. Experience in developing talent. Must exhibit high quality, ethical and compliant work habits. Experience in using Microsoft Word, Excel, and PowerPoint. Excellent scientific/technical writing skills.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion + Belonging: Committed to Welcoming, Celebrating and Thriving. Learn more about our Employee Inclusion Groups on our website https://www.smith-nephew.com/.

Benefits

• Future: Generous annual bonus and pension schemes
• Save As You Earn share options
• Work/Life Balance: Flexible vacation and time off, paid holidays, and paid volunteering hours.
• Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance, and more.
• Flexibility: Hybrid working model (for most professional roles).
• Training: Hands-on, team-customised, and mentorship-based development.
• Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes, and many other employee discounts.
• The anticipated base compensation range for this position is $125,500- $188,000 USD annually.
• In addition to base pay, we provide competitive bonus and benefits, which include medical, dental, and vision coverage, 401k, tuition reimbursement, medical leave programs, and a variety of wellness offerings.

Smith+Neb 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.

Stay connected by joining our Talent Community. We’re more than just a company – we’re a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N. Explore our website and learn more about our mission, our team, and the opportunities we offer. Smith+Neb is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential. From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Neb a unique place. Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture – of Care, Collaboration and Courage – that really sets us apart. Through a spirit of ownership and can‑do attitude we work together to win. We’re a company of people who care about each other, about our customers and their patients, and about our communities. Together, we fulfill our shared purpose of Life Unlimited.