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Job Summary

Zimmer Biomet is a global medical technology leader. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to alleviating pain and improving the quality of life for people around the world.

This position will service as the Clinical Affairs business partner and interface with other functional areas and Team Members, including but not limited to: assigned business unit(s), clinical operations, development, quality, global/regional marketing, regulatory affairs, PMS teams, medical writers, market access and the BCDM team. The Clinical Strategy Senior Manager will develop global clinical evidence requirements on specific products/brands and develop strategies to gather require clinical data in a cost effective, timely, and efficient fashion, and work closely with Clinical Operations to ensure projects are aligned with evidence needs.

The Clinical Strategy Senior Manager will have primary responsibility for the development and direction of clinical research strategy for key product lines and programs within the business unit. Responsibilities include identification of research needs, identifying and negotiating with research centers, development of protocols and research plans, assurance and monitoring of study progress, and dissemination of research products including reports, whitepapers, and manuscripts for publication. Routine interactions with health care professionals, notified bodies, registries and internal stakeholders including BU management, Clinical Operations and Biostatistics staff, Regulatory Affairs, and Compliance as required to facilitate the clinical research strategy and research program.

Principal Duties and Responsibilities

• Develops proactive clinical evidence plans on products/brands based on product/marketing claims, regional needs, Market Access, Post Market Surveillance (PMS), and Regulatory Affairs needs. Participates in the development of claims matrices for each product.
• Serves as Clinical Representative on New Product development teams to ensure clinical requirements for Gate reviews are met. Ensures clinical strategy lifecycle as well as costs are captured appropriately in the business case.
• Serves as Clinical Representative on PMS activities to ensure proactive PMCF measures are in place and being implemented in a timely manner. Analyzes and identifies critical evidence gaps in support of post market surveillance needs, and provides strategy for clinical evidence gap filling through timely and cost effective research programs.
• Contributes to MDR-readiness of responsible product portfolio by ensuring all clinically required MDR documents are prepared in a scientific manner and ready for submission to Notified Bodies (PSURs, CERs, SSCPs, CDP, PMCF plan)
• Leads creation of Project Needs Documents for newly identified clinical research projects, including Maximum FMV analyses for Investigator Initiated Research studies.
• Interfaces with researchers globally to conduct assessment on the scientific merit and business needs alignment of Investigator Initiated Research proposals with the support from the businesses.
• Collates available clinical evidence for key products, and develops and delivers effective presentations to internal and external stakeholders also in support to development activities
• Develops publication plans with support from Business, Clinical Operations, Market Access and Clinical Evidence teams. Prepare documents that support publication needs of assigned therapeutic areas or products. Write, edit, review and/or submit scientifically complex documents including abstracts, manuscripts, and podium presentations in partnership with surgeon clinical trial investigators.
• Leads cross-functional teams to develop appropriate clinical study protocols that may be executed in multiple regions, with appropriate sample sizes and subsequent publication plans to meet the needs identified in the clinical evidence plans. Serves as the subject matter expert on the technology that is being studied.
• Leads interaction regarding clinical analysis with notified bodies and other agencies inquiries
• Ensuring clinical strategy lifecycle management of dedicated product portfolio is meeting excellence and always state of the art

Expected Areas of Competence

• Expert understanding of project goals, the indication(s) studied and the purpose of the planned studies in meeting the objectives of the project. Manages all aspects of a project in accordance with established timelines, applicable project standards and standard operating procedures.
• Manages resource allocation consistent with company goals and focuses on high priority opportunities
• Excellent communication skills across all levels of the organization
• Strong organizational skills, attention to detail and ability to interpret and disseminate relevant evidence on relevant product portfolio.
• Strong knowledge of clinical research methodology, tools and processes
• Proficient in Microsoft Office Suite as well as conducting literature searches and reviews.
• Ability to critically analyze and interpret scientific data
• Understanding of statistical methods

Education/Experience Requirements

• Bachelor’s Degree required in Health, Life Sciences, or Engineering or a similar technical discipline required
• Master’s Degree or higher preferred
• Demonstrated medical writing/technical writing experience preferred
• Minimum of six (6) years of experience with research studies in medical devices with direct responsibility for submissions development and content, or an equivalent combination of education and experience
• Minimum of three (3) years of successful experience in an clinical management role or an equivalent combination of education and experience

Travel Requirements

Up to 30%

Additional Information

At Zimmer Biomet, we believe in The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. This is why we offer you a competitive rewards package that includes medical, dental, vision, life and disability insurance, wellness incentives, employee assistance programs as well as paid time off for vacation and holidays.

EOE/M/F/Vet/Disability

Compensation Range: $136,000 - $159,000/yr