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.
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.