Within CDRH, the Office of Product Evaluation and Quality (OPEQ or Super Office) is responsible for setting strategy and overseeing the Offices of Health Technology 1-7, Office of Clinical Evidence & Analysis (OCEA or Office), Office of Regulatory Programs (ORP). Using a focused Total Product Lifecycle approach, the Office ensures quality end-to-end device evaluation, and the consistent interpretation and application of regulatory policy and guidance. The Office ensures that these activities are aligned to the overall strategy and priorities of CDRH and FDA and contains staff responsible for Clinical Affairs, Quality Management and Analysis, and Strategic Initiatives.
OPEQ’s OCEA provides policy and programmatic support for clinical trials, the protection of human subjects, biostatistics, real-world evidence, epidemiological analysis and outreach, and collaborates with hospitals, health systems, industry, and other external stakeholders. Additionally, OCEA provides regulatory oversight of medical device clinical investigations, to ensure good laboratory practices and clinical practices in support of premarket review. Further, OCEA offers biostatistical and epidemiologic analyses, as well as the support in the development of data infrastructure and expertise for clinical investigations and real-world evidence.
Position Summary: CDRH is seeking an experienced, public health focused, and team-oriented Associated Director who is dedicated to improving the health outcomes of patients through innovation, evidence-based decision making, clinical/patient outcome data, and the advancement of therapeutic and diagnostic medical devices. As a luminary in the field of Epidemiology, serving as an Associate Director, you will report to the OCEA Office Director and serve as the trusted advisor focused on real-world evidence (RWE) infrastructure formation for the total product lifecycle of medical devices and radiation emitting diagnostic equipment regulated by the Center. In this critical role, you will be charged with providing expert analysis and evaluation of clinical studies submitted by industry to include design, methodology, endpoints, and conclusions. Additionally, you will evaluate the consistency and validity of industry reported information, as well as conduct real-world data assessments of medical device usage, and evaluate reported data from both the clinical and scientific communities, related to the safety, efficacy, and reliability of in scope medical products.
Duties/Responsibilities: As the Associate Director, you will:
· Utilize your expertise to develop and implement epidemiological analysis plans to evaluate clinical study data related to the therapeutic and diagnostic benefits of medical devices, diagnostic equipment, and combination products, based on intended use.
· Serve as the authoritative voice on public health surveillance and epidemiological studies and collaborate with colleagues across the Office, Super Office, Center, and Agency to lead the development of guidance documents, policies, and standards regarding the use of epidemiological studies, design, methodology, patient assessment tools, and endpoints in the evaluation of medical devices, diagnostic equipment, and combination products.
· Offer expert guidance and feedback to Office staff on medical device product reviews, to include clinical evidence and RWE focused activities and programs.
· Utilize your subject matters expertise to provide oversight of the integration of in-depth data science knowledge into analytics and visualization tools that will be utilized to support Office and Center leadership in evidenced-based regulatory decisions making regarding medical devices, combination products, and diagnostic equipment within scope.
· Serve as an expert consultant and liaison on cross-functional teams within the Office, Center, and Agency related to the development, utilization, and interpretation of patient-based studies, in particular assessment tool determination, endpoint development, data validation, and patient elicitation methods.
· As the Center’s, subject matter expert, you will keep abreast of innovative approaches to clinical study design techniques, methodology, and biostatistics.
· Directs the design, development, coordination, implementation, and management of complex public health epidemiological studies and surveillance systems to ensure programmatic and project goals and objectives are consistent, compatible, and complementary with mission of the Office and Center.
· Represent Office, the Super Office, and Center at industry, standards, and FDA advisory panel meetings to share expert position regarding study design, assessment tools, endpoints, and data collected related to real-world evidence use of medical devices, combination products, and diagnostic equipment.
· Provide epidemiologic oversight to OCEA-led analyses and interpretation of findings from RWE studies, highlighting areas of significant concern to the OCEA Office Director.
· Offers expert advice to Office, Super Office, and Center leadership on programmatic plans, health care community, scientific, and industry related trends, significant concerns, and adverse event reported data regarding medical products regulated by the Center.
· Draft recommendations, most of which will be technical in nature, to describe data science activities, analysis, results, and conclusions to assist in regulatory decision-making.
Professional Experience/Key Requirements: To qualify for this position, you must demonstrate in your resume the necessary qualifying experience for this position, which includes the following:
· Experience in evaluating, developing, and re-engineering clinical studies, as well as developing, applying, and validating assessment tools, endpoints, and methodologies.
· Evidence of a strong commitment to data quality, validation, and transparency.
· Ability to analyze and interpret regulatory policy and guidance to share expertise and advise leadership on highly complex and precedent setting public health matters.
· Leads the strategic achievement of organizational goals, evaluating organizational performance and taking action to improve performance.
· Ability to understand and interpret scientific methods and information and communicate the data to both scientific and lay audiences, in written and presentation formats
· Strong skills in using statistical tools and database software, as well as proficiency in collating and analyzing epidemiologic data
Applicants with advanced degrees in Epidemiology, Biostatistics, Mathematical Statistics, and General Mathematics and Statistics.
Conditions of Employment:
· A probationary period may be required.
· Background and/or Security investigation required.
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