FDA Regulatory Analysis of Dose- and Optimization Approaches in Targeted Oncology Therapeutics

All documents must be in English or include an official English translation. If you have questions, send an email to ORISE.FDA.CDER. Please include the reference code for this opportunity in your email.

Reference Code: FDA-CDER-

11/27/2026 3:00:00 PM Eastern Time Zone

• Applications will be reviewed on a rolling-basis.

A research opportunity is available immediately with the Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), located in White Oak, Maryland.

The Center for Drug Evaluation and Research (CDER) performs 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. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This effort covers more than just medicines.

The objective of this research project is to collect and analyze the dosage selection and optimization strategies used in recently approved and investigational targeted oncology drugs (e.g., tyrosine kinase inhibitors). The project aims to characterize trends in oncology dose-finding and selection methodologies and analyze the impact of these changes on regulatory decision‑making. During the project, you will help:

• Collect comprehensive data on dosage optimization strategies from recently approved oncology New Drug Applications (NDAs), Biologics License Applications (BLAs), and active Investigational New Drug (IND) applications for targeted oncology drugs, focusing on dose‑finding study designs, dose‑limiting toxicities (DLTs), recommended Phase 2 doses (RP2D), maximum tolerated/administrated doses (MTD/MAD), randomized dosage optimization, relevant pharmacokinetic and pharmacodynamic characteristics and exposure‑response (E‑R) relationships.
• Analyze large datasets to identify patterns, trends, and challenges in dose selection of targeted oncology drugs.
• Participate in discussions with the Division of Cancer Pharmacology (DCP) leadership, clinical pharmacology reviewers, and team leads regarding how the results of the project may impact regulatory decisions and/or guidance that protect public health.
• Present the results of the project and their conclusions to the DCP and/or a broader clinical pharmacology audience.
• Contribute to a manuscript regarding the results of the project.

• Understanding oncology‑specific dosage considerations including the transition from MTD to optimized dosing paradigms, the role of totality evidence in dosage selection, and unique challenges in oncology dose optimization.
• Understanding dose‑finding methodologies, including dose escalation and expansion strategies, randomized dosage optimization approaches, and the determination of key dosing parameters (RP2D, MTD, MAD, DLTs).
• Proficiency in navigating and extracting relevant data from NDAs, BLAs and INDs, including US prescription information (USPI), multi‑disciplinary review clinical pharmacology section, clinical protocols and reports, pharmacology sections, and dose‑finding study results.
• Competency in systematically collecting and organizing complex regulatory and clinical data from multiple sources within FDA's information systems.

You will gain regulatory science experience and policy development insight that supports advancement in clinical pharmacology, drug development, and regulatory affairs across multiple sectors.

The mentor for this opportunity is Siyan Zhu (siyan.zhu.gov). If you have questions about the nature of the research, please contact the mentor.

2026. Start date is…