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Smith+Nephew

Global medical devices for orthopedics

Senior Manager - Global Clinical Strategy

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeUnited States$125.5k - $188k /yr

About the Job

Requirements

  • A Bachelor of Science degree plus 7 years of experience or a Master of Science degree plus 3 years of experience.
  • Experience in engineering, design, a scientific or clinical subject, or a related field, including at least 3 years of direct management experience.
  • Experience in orthopaedics.
  • Ability to communicate complex concepts effectively.
  • Experience negotiating and working closely with others, and building and executing evidence strategies to achieve product reimbursement.
  • Experience presenting scientific topics to highly scientific or influential audiences and working across teams to resolve ambiguity and drive decisions.
  • Ability to work independently while maintaining inclusive approaches.
  • Strong time-management skills and ability to work under deadline pressure.
  • Experience developing talent and maintaining high-quality, ethical, and compliant work habits.
  • Experience using Microsoft Word, Excel, and PowerPoint.
  • Excellent scientific and technical writing skills.

Responsibilities

  • Develop and execute clinical and economic evidence strategies to support market access, new product development, market adoption, and registration for the Knee Robotics franchise within Orthopaedics.
  • Generate clinical and economic evidence through strategic partnerships, appropriate methodologies and tools, and collaboration with commercial, market access, and regulatory stakeholders.
  • Craft and drive pivotal initiatives across the Orthopaedics portfolio, partnering with Global and Regional Marketing, Regulatory, Market Access, and external partners; build evidence strategies covering claims, publication strategy, and conference submissions to expedite market access and expand adoption for Knee Robotics products.
  • Support Knee Robotics new product development teams by developing and executing evidence strategies on time and providing clinical support for regulatory submissions and product approvals in key markets where applicable.
  • Develop clinical strategies for MDR readiness and compliance, align with Global Clinical and Medical Affairs on evidence sufficiency, and lead execution of post-market clinical follow-up activities and timely reporting for MDR technical-file submissions, Notified Body commitments, and audit readiness.
  • Support strategic research engagement and partnerships with key opinion leaders and research centers.
  • Participate in internal and external Global Clinical Strategy audits and regulatory inspections as needed, and implement corrective and preventive actions when necessary.
  • Present progress and results to internal stakeholders at all levels of the organization.
  • Contribute to developing or updating department standard operating procedures, business processes, and policies.
  • Support regulatory documentation for new or existing products, including responses to clinical questions from regulatory authorities where applicable.
  • Ensure compliance with applicable processes, quality standards, and regulations.
  • Attend professional conferences and surgeon training labs as appropriate.
  • Manage the team, gather business needs, align stakeholders, manage budgets, and report on activities.
  • Oversee and directly support Knee Robotics portfolio clinical activities and deliverables, including liaison with key opinion leaders and clinical consultants.

About the Company

Smith+Nephew

Global medical devices for orthopedics

Smith+Nephew is a global medical technology company that designs and makes medical devices for orthopaedics, sports medicine, and advanced wound care. Its products help surgeons treat joints and soft tissues and support patient recovery, including knee repair systems, single-use negative pressure wound therapy devices, and other extremity orthopaedic products. These devices are used in hospitals and clinics to perform procedures and support healing, often after surgery or injury. The company differentiates itself with a broad, worldwide product portfolio and collaborations with healthcare organizations to improve care and efficiency for patients and providers. Its goal is to improve patient outcomes, streamline medical procedures, and expand access to advanced medical solutions around the world.

Company size
10,001+
Company stage
IPO
Headquarters
Watford, United Kingdom
Founded
1856

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