Director Of Clinical Research & Strategy

ATEC Spine has an exciting opportunity for a Director of Clinical Research &
Strategy as a member ofthe Scientific Affairs team located in Carlsbad, California. ATEC’s Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the company’s initiatives. The Clinical Research function, as a sub-function of Scientific Affairs, includes planning, coordinating, and overseeing the successful execution of preclinical and clinical research studies and large-scale data collection efforts in partnership with our surgical practice partners. Specifically, the Director of Clinical Research &
Strategy position is responsible for defining the strategic direction, resourcing, and managing the execution of the company’s clinical evidence strategy, including site-initiated and sponsored protocol-driven research studies and registry data collection and utility.
SUMMARY
From evidence generation to evidence dissemination, the Director of Clinical Research &
Strategy is a liaison between ATEC and our site-based research partners, and as a customer-facing advocate for ATEC’s mission, is empowered to take initiative and implement process-improving solutions that enable sites to be successful research partners and that support the company’s underlying research objectives. Internally, the role collaborates closely with other members of the Scientific Affairs teams as well as product marketing, development, and field representatives.
Essential Duties and Responsibilities
Along with senior management and in collaboration with relevant stakeholders, leads the development of ATEC strategy to demonstrate the value of our product and procedural solutions through the design, execution, and reporting of clinical and scientific studies
Identifies and builds relationships with key opinion leaders (KOLs) to generate clinician collaboration and relevant research projects, building and growing customer and investigator relationships that drive credibility in our products and organization
Liaises with the leadership of medical societies, research institutions, and other potential collaborators to facilitate academic partnerships, building and growing a reputation for ATEC as a research-focused organization
Oversees the appropriate review, negotiation, and execution of research agreements with sites and third-party partners
Bears ultimate responsibility for execution of research projects from start to finish, overseeing the development of study documents, including:
protocols, case report forms (CRFs), participant consent forms and other regulatory documents such as for institutional review boards (IRBs);
data collection and management, compliant to the protocol and all regulations;
data analysis;
andreport generation, both internal and external (conference presentations, peer-reviewed journal publications)
Contributes 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;
assists investigators or customers on the preparation and delivery of research results;
manages a publication and podium strategy that effectively increases ATEC’s scientific presence and reputation in the spine academic community
Maintains 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 clinical activities within the team
Collaborates with research and development engineers to provide clinical insight to projects under development
Collaborates with marketing teams to provide clinical support for product strategies, collateral creation, and sales needs
Manages the execution of projects to budget and time expectations
Performs other duties as required
Supervisory Responsibilities
Hires and manages clinical research associates, analysts, and/or other scientific personnel
Fosters continued development of team members, including technical and clinical expertise
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.
Comprehensive knowledge of the healthcare and medical device industry
History of clinical research publication, including a well-established publication record
Proficiency in conducting literature searches and critically evaluating and communicating findings
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
Knowledge, understanding, and application of the ethical conduct of clinical investigations involving humans in accordance ICH/GCP, US Code of Federal Regulations (CFR), and other countries’ regulations
Excellent communication skills, both verbal and written, to communicate internally and externally with investigators and customers
High relational skills, highly dynamic, project management and execution focused
Superior problem-solving skills with a solid understanding of scientific data collection and management methods
Fluent in statistical analysis and data visualization
Superior organization skills, attention to detail, and the ability to keep detailed, accurate records
Ability to organize and prioritize workflow to meet established timeframes, while working in a fast-paced and goal-oriented environment
Self-motivating, self-starter
Ability to work within a cross-functional team and matrix management structure
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 required, advanced degree (MS, PhD) in a field of science preferred;
and ten (10) or more years of progressive research experience including management role(s), preferably in medical device (spine industry a plus), demonstrating knowledge of GCP and research processes. Experience managing a team preferred.
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. $175,000 to $225,000 Full-Time Annual Salary.