Senior Manager, Global Clinical Strategy

Smith & Nephew; United States; On-site; USD 126,000 - 188,000; Full time

Benefits offered by this job

Hybrid work model

Performance bonuses

Private health and dental plans

Pension schemes

Job summary

Smith+Nephew is seeking a Senior Manager, Global Clinical Strategy to lead clinical and economic evidence strategies in support of market access and product development within the Knee Robotics franchise.

You will drive cross-functional collaboration with Global Marketing, Regulatory, and external partners to optimize evidence generation and align with business needs. Hybrid work model and strong compensation package included.

Qualifications

• Experience crafting and directing clinical/economic evidence strategies.
• Proven ability to lead cross-functional teams and partner with regulatory and market access.
• Strong scientific writing and communication skills.

Responsibilities

• Drive pivotal clinical initiatives across Orthopaedics portfolio.
• Support MDR readiness and PMCF activities; ensure timely reporting.
• Collaborate with KOLs and research centers on evidence generation.
• Lead or participate in audits, CAPAs, and regulatory inspections as needed.

Skills

Clinical strategy

Team leadership

Stakeholder management

Regulatory submissions

Medical writing

Education

Bachelor's degree + 7 years

Master's degree + 3 years

Tools

MS Office

Job description

## Senior Manager, Global Clinical StrategyApply: US - Field: Full time: Posted Today: R92833**Life Unlimited.** At Smith+Nephew, we 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/* our 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. The actual base pay offered to the successful candidate will be based on multiple factors, including but not limited to job-related knowledge/skills, experience, geographical location, and internal equity. It is not typical for an individual to be hired at the high end of the range for their role at Smith + Nephew. Compensation decisions are dependent upon the facts and circumstances of each position and candidate.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.