Job Details
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