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Alphatec Spine

Scientific Evidence Manager

Alphatec Spine, Carlsbad, California, United States, 92011

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Scientific Evidence Program Manager

The Scientific Evidence Program Manager will lead the development and management of scientific evidence generation programs to support ATEC's product initiatives. This role is pivotal in supporting the strategic objectives of the organization by ensuring that research studies are designed and executed to generate high-quality evidence that supports product claims, regulatory submissions, and market access. The successful candidate will collaborate closely with cross-functional teams, including Marketing, research teams within Scientific Affairs, Clinical Operations, Research and Development, and Regulatory Affairs. Essential Duties and Responsibilities Work with cross-functional teams to identify evidence needs and align evidence-generation activities with business goals, including demonstrating the value of our product and procedural solutions. Develop and oversee comprehensive scientific evidence generation plans. Track study progress and ensure milestones are met on time and within budget. Maintain current knowledge of regulations and guidelines affecting scientific evidence generation. Monitor industry trends and regulatory changes to inform evidence strategies. Design and manage scientifically robust prospective and retrospective clinical study protocols and registries with clear objectives, endpoints, and statistical analysis plans. Ensure studies comply with regulatory requirements, good clinical practice (GCP), and ethical standards. Identify and build relationships with key opinion leaders (KOLs) to promote clinician collaboration on relevant projects, building and growing customer and investigator relationships that drive credibility in our products and organization. Collaborate with Scientific Affairs research teams to execute studies, interpret study results and generate reports, publications, and presentations. Present findings to internal and external stakeholders, including regulatory bodies, key opinion leaders, and healthcare professionals. Contribute to the dissemination of scientific findings through presentation and writing for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, product/procedural training and collateral; assist investigators or customers on the preparation and delivery of research results; manage a publication and podium strategy that effectively increases ATEC's scientific presence and reputation in the spine academic community. Maintain a high level of engagement with clinicians and academicians and their scientific findings through attendance at scientific conferences, regularly assessing published literature for trends or novel concepts (with consideration for ATEC solutions and competition), and direct interactions with research partners, peers, and industry colleagues. Collaborates closely with other members of the Scientific Affairs team, through meetings and interactions to gather technical and clinical support as well as to ensure alignment of the research activities within the team. Performs other duties as required.