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Scientific Evidence Program Manager

3 months ago

Carlsbad, United States Alphatec Spine Full time

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.

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Proven track record of designing and managing scientific evidence generation strategies.
  • Strong knowledge of research study design, GCP, and regulatory requirements.
  • High relational skills, highly dynamic, project management and execution focused.
  • Comprehensive knowledge of the healthcare and medical device industry
  • Superior problem-solving skills with a solid understanding of scientific data collection and management methods.
  • Ability to build and maintain mutually respectful relationships with clinicians and scientists.
  • Experience collaborating with external stakeholders on clinical research projects, building or managing both sponsor- and investigator-initiated studies.
  • Excellent communication skills, both verbal and written, to communicate internally and externally with investigators and customers.
  • Ability to work effectively in a cross-functional and dynamic team environment.
  • Superior organization skills, attention to detail, and the ability to keep detailed, accurate records.
  • Self-motivating, self-starter.
  • Ability to exercise independent judgment consistent with department guidelines.
  • Ability to learn and maintain knowledge of procedures, products, and activities of assigned area.
  • Proficiency with common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) required.
  • Ability to travel as needed for conference and symposium support and physician engagement.

Education and Experience

  • Minimum of Bachelors' degree in a field of science required, advanced degree (MS, PhD) preferred.
  • Certification or degree in strategic planning and management desired.
  • Ten (10) or more years of medical device experience (spine industry a plus).

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $120,000 to $150,000 Full-Time Annual Salary