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Manager of Scientific Evidence Programs

2 months ago

Carlsbad, United States Alphatec Spine Full time

The Manager of Scientific Evidence Programs will spearhead the formulation and oversight of scientific evidence initiatives to bolster Alphatec Spine's product strategies. This position is crucial in aligning with the organization’s strategic goals by ensuring that research projects are meticulously crafted and executed to yield high-caliber evidence that substantiates product assertions, regulatory applications, and market accessibility.

Key Responsibilities

  • Collaborate with interdisciplinary teams to pinpoint evidence requirements and synchronize evidence generation efforts with corporate objectives, including showcasing the value of our product and procedural offerings.
  • Devise and supervise thorough scientific evidence generation frameworks. Monitor study advancements and guarantee that milestones are achieved punctually and within budgetary constraints.
  • Stay abreast of regulations and guidelines influencing scientific evidence generation. Observe industry trends and regulatory modifications to refine evidence strategies.
  • Craft and oversee scientifically sound prospective and retrospective clinical study protocols and registries with defined objectives, endpoints, and statistical analysis methodologies. Ensure compliance with regulatory standards, good clinical practices (GCP), and ethical guidelines.
  • Establish and nurture relationships with key opinion leaders (KOLs) to foster clinician collaboration on pertinent projects, enhancing and expanding customer and investigator relationships that reinforce credibility in our products and organization.
  • Work alongside Scientific Affairs research teams to implement studies, interpret findings, and produce reports, publications, and presentations. Share results with internal and external stakeholders, including regulatory entities, key opinion leaders, and healthcare professionals.
  • Contribute to the dissemination of scientific insights through presentations and written materials for both internal and external audiences, including interim reports, conference abstracts, presentations, manuscripts, and training materials; assist investigators or clients in preparing and delivering research outcomes; manage a publication and presentation strategy that effectively enhances Alphatec's scientific visibility and reputation within the spine academic community.
  • Maintain a high level of engagement with clinicians and academicians and their scientific findings through participation in scientific conferences, routinely reviewing published literature for trends or innovative concepts (considering Alphatec solutions and competition), and direct interactions with research partners, peers, and industry colleagues.
  • Collaborate closely with other members of the Scientific Affairs team through meetings and interactions to gather technical and clinical support and ensure alignment of research activities within the team.
  • Perform additional duties as necessary.

Qualifications

The qualifications listed below represent the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Demonstrated success in designing and managing scientific evidence generation strategies.
  • In-depth knowledge of research study design, GCP, and regulatory requirements.
  • Exceptional interpersonal skills, highly dynamic, with a focus on project management and execution.
  • Comprehensive understanding of the healthcare and medical device sector.
  • Outstanding problem-solving abilities with a solid grasp of scientific data collection and management techniques.
  • Capacity to build and sustain mutually respectful relationships with clinicians and scientists.
  • Experience collaborating with external stakeholders on clinical research projects, including both sponsor- and investigator-initiated studies.
  • Excellent verbal and written communication skills to effectively engage with investigators and clients.
  • Adept at working effectively in a cross-functional and dynamic team environment.
  • Superior organizational skills, attention to detail, and the ability to maintain accurate records.
  • Self-motivated and proactive.
  • Ability to exercise independent judgment in line with departmental guidelines.
  • Capacity to learn and retain knowledge of procedures, products, and activities relevant to the assigned area.
  • Proficiency in common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications, etc.) is required.
  • Willingness to travel as necessary for conference and symposium support and physician engagement.

Education and Experience

  • Minimum of a Bachelor's degree in a scientific discipline is required; an advanced degree (MS, PhD) is preferred.
  • Certification or degree in strategic planning and management is desirable.
  • Ten (10) or more years of experience in the medical device field (experience in the spine industry is a plus).

Alphatec Spine is dedicated 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. Furthermore, Alphatec will make reasonable accommodations necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. adheres to state and federal wage and hour laws, and compensation is contingent upon the candidate's qualifications, education, skill set, years of experience, and internal equity. The salary range is $120,000 to $150,000 for a full-time annual position.