FDA- Deputy Office Director - Office of Drug Evaluation Sciences

Mission: Ensure the availability of safe and effective drugs to enhance public health in the United States.

A Day in the Life:

As a research expert for the FDA, you will review new drugs to ensure that they’re safe and effective while also supervising a small team.

· Before testing on humans: You will check if the drug’s design is sound.

· For approval: You will evaluate clinical trial results and labeling accuracy to ensure the drug works as intended and has clear instructions and warnings.

· For existing drugs: You will review updates, safety reports, and potential new uses or label changes.

You will work with your team to make evidence-based decisions.

· You will analyze summaries from other experts and recommend approving, requesting more data, or rejecting applications.

· You will consult with other specialists to address complex issues and stay up to date on scientific advancements.

· You will share your expertise through conferences and publications.

Position Requirements:

Education:

· PhD or equivalent from an accredited school with completed fellowship.

*And/or Doctor of Medicine, Doctor of Osteopathic Medicine, or equivalent from a school in the United States or Canada. This degree must have been accredited by the Council on Medical Education of the American Medical Association; Association of American Medical Colleges; Liaison Committee on Medical Education; Commission on Osteopathic College Accreditation of the American Osteopathic Association, or an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained.

Needed Experience:

· Ability to apply clinical and scientific knowledge to complex medical problems and benefit/risk management.

· Enjoys solving unique problems and addressing challenges in drug/biologic regulatory review.

· Desire to stay current on the latest clinical information in your assigned therapeutic area.

· Capable of strong written and verbal communication.

Key Outcomes:

Facilitating Drug Development Advances: Spearhead the qualification and adoption of novel tools, such as biomarkers and clinical outcome assessments (COAs), to enhance drug development processes.

Enhancing Safety Data Analysis: Develop and implement standardized approaches and tools for safety data analysis, aiming for more effective and efficient pre-market data evaluations.

Improving Diversity in Drug Development: Oversee initiatives to ensure diversity in patient participation in clinical trials, collaborating with internal and external stakeholders to enhance efficacy and safety data representation.

Leading Regulatory Science Research: Initiate and support research efforts focused on developing innovative drug development tools and approaches, including biomarkers and COAs.

Optimizing Regulatory Processes: Provide strategic guidance and leadership in developing regulations, guidance documents, and policies related to novel drug development tools and approaches.

Fostering Stakeholder Engagement: Facilitate outreach and engagement with scientific organizations, patient groups, and pharmaceutical companies to promote the incorporation of new tools into drug development and regulatory processes.

Managing Organizational Resources: Ensure efficient resource allocation and management to support the effective functioning of the office and its divisions.

Promoting Workforce Diversity and Development: Recruit, retain, and develop a diverse and skilled workforce to achieve organizational objectives, fostering an inclusive workplace culture.

Ensuring Regulatory Compliance: Uphold equal employment opportunity (EEO) principles and non-discriminatory practices in all aspects of personnel management and decision-making.

Technical Expertise and Collaboration: Provide expertise in regulatory health management, collaborate with internal and external partners, and contribute to the advancement of regulatory science.

General Medical and Healthcare Series, 0601