At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered, and recognized.

What You Can Expect

Designs, develops, modifies, and implements global clinical strategies and plans in collaboration with multiple business units, regional marketing, market access and clinical operations based on strong knowledge of the device and relevant science in order to meet regulatory and commercial targets. Creates and articulates a vision. Sets priorities and allocates resources. Drives innovation through embracing diversity and change. Takes accountability and achieves results. Develops self and others. Sets the example and thereby shapes the culture. 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 Associate Director will develop global clinical evidence requirements on specific products/brands and develop strategies to gather required clinical data in a cost effective, timely, and efficient fashion, and work closely with Clinical Operations to ensure projects are aligned with evidence needs.

How You'll Create Impact

Clinical Strategy Development:

• Lead the development and execution of robust clinical strategies for the orthopedic product lines, emphasizing infection related product lines, like coatings as well as surgical and biologic product lines .

• Collaborate cross-functionally to align clinical development plans with overall business objectives.

• 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.

• Develops publication plans with support from Business, Clinical Operations, Market Access and Scientific Communication team for key clinical projects to ensure that clinical results are disseminated in an appropriate and timely fashion.

• Develops and manages annual research budgets

• Ensuring clinical strategy lifecycle management of dedicated product portfolio is meeting excellence and always state of the art

• Leads interaction regarding clinical strategy with notified bodies and other agencies inquiries

Infection Research Expertise:

• Stay abreast of advancements in infection research, applying insights to enhance the safety and efficacy of orthopedic products as well as acting as an SME towards internal and external stakeholders

Combination Products and FDA Approval:

• Navigate regulatory guidelines to strategize and execute plans for FDA approval of combination products.

• Develop and manage regulatory submission strategies, ensuring compliance with applicable regulations.

MDR Readiness:

• Oversee and contribute to activities ensuring the organization's readiness for compliance with the Medical Device Regulation (MDR) ensuring documentation is prepared in a scientific manner and ready for submission to Notified Bodies (PSURs, CERs, SSCPs, CDP, PMCF plan).

• Collaborate with Regulatory Affairs and Medical Writing as well as Post Market Surveillance

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teams to assess and implement changes required for MDR compliance.

Clinical Trial Design and Management:

• Design and oversee clinical trials, ensuring alignment with regulatory and business requirements and MDR standards.

• Work closely with clinical operations teams to monitor trial progress and address issues.

Cross-functional Collaboration:

• Collaborate with R&D, regulatory affairs, quality assurance, and marketing teams to integrate clinical and regulatory strategies into the product development lifecycle as well as acting as clinical representative in NPI projects.

Risk Management and Mitigation:

• Identify and address potential risks associated with clinical development, regulatory pathways, and MDR compliance.

• Provide guidance on risk-benefit assessments for regulatory submissions.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

What Makes You Stand Out

• 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 consolation on disseminate relevant evidence on relevant product portfolio.

• Strong knowledge of clinical protocols research methodology, tools and other documents/plans to optimize study design processes

• Proficient in Microsoft Office Suite as well as conducting literature searches and improve plan quality reviews.

• Interprets clinical data and makes appropriate decisions and recommendations based on safety and efficacy of the device under investigation. Provides written medical review of patient adverse events related to the study.

• Serves as a program champion to motivate and lead researchers (both inside and outside the company) toward clinical goals.

• Advises and informs senior management and other stakeholders of research progress and raises issues that will have an impact on the group or project.

• Provides scientific/medical expertise and leadership to cross-functional working groups to support the attainment of research goals. • Ability to critically analyze and interpret scientific data

• Strong oral and written communication skills and proven skill in negotiating directly with HCPs and their staff

• Familiarity with orthopedic medical device products and infection related solutions is preferred.

Your Background

• Master’s degree in health, life sciences, or engineering; (PhD Degree or higher preferred)

• Minimum of 10+ years of experience; clinical research in medical devices or similar experience with an emphasis on study ideation, execution, and evidence dissemination direct responsibility for submissions development and content, or an equivalent combination of education and experience

• Management Minimum of three (3) years of successful experience, including the direct supervision of in an clinical research staff, is preferred.

• Clinical study design, FDA/Notified Body interaction management role or an equivalent combination of education and negotiation, and study launch and clinical monitoring experience preferred

• Experience specific in Infection

• Experience in Ortho preferred or in Pharma, Med Device, or Academia

Travel Expectations

Up to 20%

EOE/M/F/Vet/Disability

Compensation Range: $165,000 - $185,000

The compensation for this position may vary depending on location.

Location: Fully Remote