Scientific Evidence Program Manager

3 weeks ago

Carlsbad CA USA, United States Alphatec Spine Full time
Job Title: Scientific Evidence Program Manager

Alphatec Spine is seeking a highly skilled Scientific Evidence Program Manager to lead the development and management of scientific evidence generation programs. 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.

Key Responsibilities:
  • Collaborate with cross-functional teams to identify evidence needs and align evidence generation activities with business goals.
  • Develop and oversee comprehensive scientific evidence generation plans, ensuring milestones are met on time and within budget.
  • Maintain current knowledge of regulations and guidelines affecting scientific evidence generation, monitoring industry trends and regulatory changes to inform evidence strategies.
  • Design and manage scientifically robust prospective and retrospective clinical study protocols and registries, ensuring compliance with regulatory requirements, good clinical practice (GCP), and ethical standards.
  • Build relationships with key opinion leaders (KOLs) to promote clinician collaboration on relevant projects, driving 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, KOLs, and healthcare professionals.
Requirements:
  • Strong knowledge of research study design, GCP, and regulatory requirements.
  • High relational skills, project management, and execution focus.
  • 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 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.
  • Six (6) or more years of medical device experience (spine industry a plus).

Alphatec Spine is an equal opportunity employer and complies with all applicable federal, state, or local laws. Compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $120,000 to $150,000 Full-Time Annual Salary.

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