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Manager of Scientific Evidence Programs

2 months ago


Carlsbad, United States Alphatec Spine Full time
Job Overview

The Manager of Scientific Evidence Programs will spearhead the creation and oversight of scientific evidence initiatives to bolster Alphatec Spine's product strategies. This role is crucial in aligning research efforts with the organization's strategic goals, ensuring that studies are meticulously designed and executed to yield high-quality evidence that substantiates product claims, regulatory filings, and market entry.

Key Responsibilities

  • Collaborate with cross-functional teams to pinpoint evidence requirements and synchronize evidence generation efforts with business objectives, showcasing the value of our product and procedural solutions.
  • Formulate and manage comprehensive scientific evidence generation strategies. Monitor study advancements and ensure that milestones are achieved within designated timelines and budgets.
  • Stay informed about regulations and guidelines influencing scientific evidence generation. Track industry trends and regulatory developments to refine evidence strategies.
  • Design and oversee scientifically rigorous prospective and retrospective clinical study protocols and registries with defined objectives, endpoints, and statistical analysis frameworks. 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 credibility in our products and organization.
  • Work alongside Scientific Affairs research teams to implement studies, analyze results, and produce reports, publications, and presentations. Share findings with internal and external stakeholders, including regulatory authorities, KOLs, 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 elevates Alphatec's scientific visibility and reputation within the spine academic community.
  • Maintain active engagement with clinicians and academicians, staying abreast of scientific developments through attendance at conferences, reviewing published literature for emerging trends or innovative concepts, and direct interactions with research partners 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.
  • Perform additional duties as necessary.

Qualifications

The qualifications listed below are representative of the knowledge, skills, and 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.
  • Strong understanding of research study design, GCP, and regulatory standards.
  • Excellent interpersonal skills, highly dynamic, with a focus on project management and execution.
  • Comprehensive knowledge of the healthcare and medical device sectors.
  • Exceptional problem-solving abilities with a solid grasp of scientific data collection and management methodologies.
  • Capacity to build and sustain respectful relationships with clinicians and scientists.
  • Experience collaborating with external stakeholders on clinical research initiatives, managing both sponsor- and investigator-initiated studies.
  • Outstanding communication skills, both verbal and written, to effectively engage with investigators and clients.
  • Ability to thrive in a cross-functional and dynamic team environment.
  • Superior organizational skills, attention to detail, and capability to maintain precise, accurate records.
  • Self-motivated and proactive.
  • Ability to exercise independent judgment in accordance 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 clinician 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 industry (experience in the spine sector is a plus).

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

Compensation

Alphatec Spine, Inc. adheres to state and federal wage and hour regulations, and compensation is based on the candidate's qualifications, education, skill set, years of experience, and internal equity.