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Scientific Evidence Strategy Lead

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 generation initiatives to bolster Alphatec Spine's product strategies. This position is crucial in advancing the organization's strategic goals by ensuring that research projects are meticulously designed and executed to yield high-quality evidence that substantiates product claims, regulatory submissions, and market access.

Key Responsibilities

  • Collaborate with cross-functional teams to pinpoint evidence requirements and synchronize evidence generation efforts with business objectives, including demonstrating the value of our products and procedural solutions.
  • Develop and manage comprehensive scientific evidence generation plans. Monitor study progress and ensure that milestones are achieved within the designated timeline and budget.
  • Stay updated on regulations and guidelines impacting scientific evidence generation. Track industry trends and regulatory developments to inform evidence strategies.
  • Design and oversee scientifically rigorous prospective and retrospective clinical study protocols and registries with well-defined objectives, endpoints, and statistical analysis plans. Ensure compliance with regulatory standards, good clinical practice (GCP), and ethical norms.
  • Identify and cultivate relationships with key opinion leaders (KOLs) to foster clinician collaboration on pertinent projects, enhancing credibility in our products and organization.
  • Work closely with Scientific Affairs research teams to execute studies, interpret results, and generate reports, publications, and presentations. Present findings to both internal and external stakeholders, including regulatory bodies and healthcare professionals.
  • Contribute to the dissemination of scientific findings through presentations and written materials for diverse audiences, including interim reports, conference abstracts, presentations, and training materials; assist investigators or clients in preparing and delivering research outcomes; manage a publication strategy that effectively enhances Alphatec's scientific visibility and reputation in the academic community.
  • Maintain active engagement with clinicians and academicians through attendance at scientific conferences, regularly reviewing published literature for trends or innovative concepts, and direct interactions with research partners and industry colleagues.
  • Collaborate closely with other members of the Scientific Affairs team 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.
  • Exceptional interpersonal skills, highly dynamic, with a focus on project management and execution.
  • Comprehensive knowledge of the healthcare and medical device sectors.
  • Outstanding problem-solving abilities with a solid grasp of scientific data collection and management methodologies.
  • Ability to establish and maintain respectful relationships with clinicians and scientists.
  • Experience in collaborating with external stakeholders on clinical research projects, managing both sponsor- and investigator-initiated studies.
  • Excellent verbal and written communication skills for effective interaction with investigators and clients.
  • Capability to work efficiently in a cross-functional and dynamic team environment.
  • Superior organizational skills, attention to detail, and ability to maintain accurate records.
  • Self-motivated and proactive.
  • Ability to exercise independent judgment in accordance with departmental guidelines.
  • Capacity to learn and maintain knowledge of procedures, products, and activities in the assigned area.
  • Proficiency in common computer applications (e.g., Microsoft Word, Excel, PowerPoint, Windows, Internet applications).
  • Willingness to travel as necessary for conference support and physician engagement.

Education and Experience

  • A minimum of a Bachelor's degree in a scientific field is required; an advanced degree (MS, PhD) is preferred.
  • Certification or degree in strategic planning and management is desirable.
  • At least ten (10) 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 all 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 applicable laws. Additionally, Alphatec will make reasonable accommodations necessary to comply with disability discrimination laws.

Compensation

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