Job Description

Job Summary

Zimmer Biomet is a world leader in musculoskeletal health solutions. 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.

Responsible for Research project planning, execution, management, and reporting with regards to pre-clinical evaluation, animal studies, biomechanical testing, pre- or post-market clinical studies to support product development, regulatory requirements, product market positioning/adoption, or business needs. Responsible for leading or managing the development and deliverables of scientific compendiums, white papers, presentations, and publications for the business based on scientific, clinical, and health economic evidences. Serves as a subject matter expert, and scientific advisor to R&D, Marketing, Sales, Clinical Affairs, Regulatory (list is not exhaustive). Acts as a scientific liaison between external key opinion leaders and Zimmer Biomet as well as a project manager to support committee review and approval of investigator initiated research and provide contract management support and project oversight of the external research program. Collaborates in project work with surgeons, investigators, external laboratories, service providers, as well as internal departments such as product development, process engineering, quality, regulatory, marketing, and Zimmer Biomet Corporate (list is not exhaustive).

Principal Duties and Responsibilities

* Plan and design experiment, develop research protocol, and manage research projects for pre-clinical animal studies, biomechanical testing, or biocompatibility testing; work with legal to support research/service contract development/management; coordinate with surgeons and laboratory services; collect and analyze data; develop white papers or reports to support product development, claim matrix, or regulatory submission.
* Lead or support on planning, preparation, and execution of pre- or post- market clinical studies; develop study protocols, collect and analyze data, and generate study reports to support regulatory submission, scientific publications, and product commercialization.
* Point of contact in liaison with and provide support to the investigators and clinical investigation research committee for external research program or investigator initiated research; coordinate the committee review and approval process in working with the cross-functional stakeholders; provide contract management support and project oversight of milestones and deliverables.
* Conduct literature search, review, and assessment to develop scientific compendiums, white papers, or meta-analyses for evidence-based education or commercial materials.
* Represent the company via presentations to groups of experts, scientific societies, or regulatory bodies.
* Provide scientific expertise or evidence dissemination to the global marketing and sales teams. Maintain relevant scientific and clinical knowledge by attending conferences, courses and meetings
* Educate internal colleagues across functions in the areas of biomechanical, biocompatibility, and safety/performance evaluations, along with benefit/risk assessments and knowledge of scientific, clinical, and health economic evidences.

Expected Areas of Competence

* Has shown competencies as a subject matter expert in the primary areas of duties and responsibilities.
* Familiarity with standards and practices used in the clinical research of medical devices, such as ISO 14155: 2011 Clinical investigation of medical devices for human subjects -Good clinical practice, The Declaration of Helsinki -Ethical principles for medical research involving human subjects, US Code of Federal Regulations 21 CFR Parts 11, 50 and 56.
* Working knowledge of experimental design, animal study, biomechanical testing, biocompatibility testing, implantable medical device clinical studies. Proven competency in presenting scientific and clinical data to expert groups and key opinion leaders in a clear and convincing matter.
* Open mindset to collaborate with business partners, conduct research, and generate evidence to meet the business needs with high standards of integrity, quality, and compliance.
* Strong critical thinking, analytical, and problem solving skills. Able to analyze complex aspects of a situation, identify potential solutions, and implement the best solution in a timely manner.
* Strong sense of purpose, accountability, and result orientation. Flexible teamwork style, easy to approach, communicate, and collaborate with team members. Respect diversity and inclusion, be positive to the team and team culture.
* Is professional, concise, and sensitive in accomplishing objectives. Is able to diplomatically negotiate with a requester regarding what they want in design, process, scope or timetable
* Demonstrates strong written and verbal communication skills including presentation skills. Has ability to tailor the information to the audience and answer scientific questions with confidence and authority.
* Demonstrates ability to discuss sensitive information with and tailor communication style to listeners perspectives, including management, surgeons, and external contacts.
* Shows leadership skills and initiative.

Education/Experience Requirements

* Minimum educational requirement is a MS (PhD degree preferred) in relevant scientific disciplines, such as biology, chemistry, biomedical engineering, and/or toxicology
* 5+ years of experience in medical device research (Orthopaedic industry preferred) or an equivalent combination of PhD, Postdoctoral, and experience in related field required

Travel Requirements

* Up to 20%

Additional Information

EOE M/W/Vet/Disability.

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.