Director, Clinical Research & Strategy
Location: Carlsbad
Posted on: June 23, 2025
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Job Description:
ATEC Spine has an exciting opportunity for the Director of
Clinical Research & Strategy as a member of the 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 part 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 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. 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 • Leads the
development of strategy to demonstrate the value of our product and
procedural solutions through the design, execution, and reporting
of clinical studies • Leads the strategic integration of
multi-modal clinical data—including patient outcomes and EOS
imaging alignment metrics—to enable advanced predictive modeling
for surgical planning. • Identifies and builds deep 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; and report 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 • Work with cross-functional
teams to identify evidence needs and align evidence-generation
activities with business goals, including demonstrating the value
of our product and procedural solutions. • Partners with data
science, informatics, and clinical teams to define and
operationalize real-world evidence strategies, including
integration of ATEC’s Insight platform into clinical studies and
longitudinal outcomes tracking. • Champions the inclusion of
functional and patient-reported outcomes in study design to reflect
the true value of ATEC’s procedural solutions and improve alignment
with evolving value-based care metrics. • 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 in a field of science
required; MS, PhD preferred • Ten years of Medical Device
experience required, (spine industry a plus); experience managing a
team strongly preferred.
Keywords: , Arcadia , Director, Clinical Research & Strategy, Science, Research & Development , Carlsbad, California
