FDA - Associate Director for Regulatory Science, Division of Clinical Outcome Assessment
AE Strategies
Silver Spring, MD
FDA - Associate Director for Regulatory Science, Division of Clinical Outcome Assessment
AE Strategies
Silver Spring, MD
- Full-Time
Job Description
Company Info
Job Description
Description
Function Duties and Responsibilities
Desired Education, Skills, or Experience
The Food and Drug Administration (FDA) has selected AE Strategies as its strategic recruiting partner, helping to find candidates for full-time federal positions across the Agency. AE Strategies' role is to identify and pre-screen candidates, and then to introduce these candidates to hiring managers at the FDA.
Introduction
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs, and medicated feeds for food-producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
Introduction
The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs, and medicated feeds for food-producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Center for Drug Evaluation and Research (CDER) is to perform an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.
Function Duties and Responsibilities
The Associate Director is responsible for assisting the Division Director with the direction, technical oversight, and leadership of division staff comprised of multi-disciplinary scientific review teams. These teams review and provide consults in relation to study endpoint and labeling issues that affect the approvability of regulatory submissions and applications.
Assists the Division Director with direction, technical oversight, and leadership of division staff on the following:
Assists the Division Director with direction, technical oversight, and leadership of division staff on the following:
- Provides consultation and advice to OND review divisions and other FDA Centers on Clinical Outcome Assessment (COA) development, validation, and interpretation as the basis for effectiveness endpoints in clinical trials for investigational New Drug (ND), New Drug Application (NDA) and Biologics License Applications (BLA) submissions.
- Develops, validates, and incorporates endpoint considerations into clinical trial design, conduct, analysis, interpretation, and reporting for regulatory determinations of medical product benefit.
- Consults and advises COA developers under the COA Drug Development TOOL (DDT) qualification program, as well as, review for qualification decisions. Manages the qualification process for COAs intended to address unmet public health needs. Works directly with requestors in guiding COA development of qualification.Encourages a collaborative, multidisciplinary setting where CDER can review COAs and provide advice on the development or modification of COAs outside the IND/NDA/BLA pathway.
- Develops regulatory policy for clinical outcome assessment to generate evidence of treatment benefit and support claims in labeling.
- Coordinates policies that span throughout all FDA programs including patient-reported outcomes, observer-reported outcomes, clinician-reported outcomes, performance outcome measures, and innovative drug development tools (e.g., digital health technology tools).
- Participates in the integrated drug review process to ensure that COAs are fit-for-purpose and their corresponding endpoints well-defined and reliable with respect to their context of use in support of medical product labeling and promotional claims.
- Provides training to CDER, CBER, and CDRH reviewers on measurement issues in medical product development in general, but especially, in areas where the FDA has prioritized the development of new medical products and the advancement of tools and methods.
Assists the Division Director with the following activities in general, but especially, in areas where the FDA has prioritized the development of new medical products and the advancement of tools and methods (e.g., rare disease drug development, digital health technology tools, etc.):
- Oversight of the Agency's COA DDT Qualification Program.
- Subject matter expertise to OND review divisions on the use of COAs in drug-specific development programs and Patient-Focused Drug Development activities.
- Engagement with internal and external stakeholders to advance the development of scientific standards and regulatory policy for COAs, especially in areas of priority such as rare disease drug development and digital health technology tools.
On behalf of the Division Director, leads the development and implementation of good measurement standards in clinical trials:
- FDA guidance and policy development related to COAs as effectiveness endpoints.
- Promotes the development and implementation of COAs as drug development tools to improve drug development.
- Outreach to and collaboration with industry, instrument developers, patient representatives, academia, and other government agencies, both Federal and international (e.g., NIH, EMA), to advance the science of measurement in clinical trials.
Assists with management of the CDER DDT COA Qualification Program:
- Consultation and advice to instrument developers to guide the development of COAs ultimately intended for use as primary or secondary endpoints in clinical trials.
- Program activities performed by multi-disciplinary teams in the review of submissions for CDER COA DDT qualification.
- Lead participation in public-private partnerships to develop COAs in general, but especially, in areas where the FDA has prioritized the development of new medical products and the advancement of tools and methods (e.g., rare disease drug development, digital health technology tools, etc.)
Provides leadership, guidance, and/or regulatory expertise to address and solve complex regulatory issues consistent with technological developments or new scientific evidence and provides innovative solutions to complex problems. Makes decisions or provides concurrence on issues of this nature presented by the COA Staff.
Desired Education, Skills, or Experience
Degree: Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences, or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.
Candidates who have earned a doctoral or medical degree in life or biomedical sciences, pharmacology, chemistry, biology, sociology, statistics, epidemiology, or a related field, are preferred.
Specialized Experience
Ability to drive collaboration, innovation, and empower division staff; knowledge of leadership principles and concepts.
Experience with expert advice and consultation, spearheading and coordination of program activities, and regulating and evaluating new drugs and biological products.
Ability to lead a diverse interdisciplinary staff and influence cross-disciplinary, integrated teams.
Candidates who have earned a doctoral or medical degree in life or biomedical sciences, pharmacology, chemistry, biology, sociology, statistics, epidemiology, or a related field, are preferred.
Specialized Experience
Ability to drive collaboration, innovation, and empower division staff; knowledge of leadership principles and concepts.
Experience with expert advice and consultation, spearheading and coordination of program activities, and regulating and evaluating new drugs and biological products.
Ability to lead a diverse interdisciplinary staff and influence cross-disciplinary, integrated teams.
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