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

Oak Ridge Institute for Science and Education; White Oak (MD); On-site; USD 27,000 - 45,000; Full time

Job summary

Oak Ridge Institute for Science and Education (ORISE) offers a full-time research opportunity with FDA-CDER in White Oak, MD. The project focuses on collecting and analyzing dosage selection strategies for oncology drugs, including RP2D, MTD/MAD, and DLTs.

You will engage with leadership, present findings, and contribute to manuscripts. Eligibility requires a master's or doctoral degree in a relevant field.

Qualifications

• The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields.

Responsibilities

• Collect and analyze dosage optimization strategies from recent NDAs, BLAs, and INDs for targeted oncology drugs.
• Identify patterns and trends in dose-finding study designs, RP2D, MTD/MAD, and exposure‑response relationships.
• Discuss findings with FDA clinical pharmacology leadership and team leads to inform potential regulatory guidance.
• Present results to DCP or clinical pharmacology audiences and contribute to a manuscript.

Education

Master's Degree or Doctoral Degree

Job description

All documents must be in English or include an official English translation. If you have questions, send an email to [e-mail]. Please include the reference code for this opportunity in your email.

Reference Code: FDA-CDER-2026-0183

Application Deadline

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

Description

• Applications will be reviewed on a rolling-basis.

FDA Office and Location

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.

Research Project

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.

Learning Objectives

• 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.

Mentor

The mentor for this opportunity is Siyan Zhu ([e-mail]). If you have questions about the nature of the research, please contact the mentor.

Anticipated Appointment Start Date

2026. Start date is flexible and will depend on a variety of factors.

Appointment Length

The appointment will initially be for one year, but may be renewed upon recommendation of FDA and is contingent on the availability of funds.

Level of Participation

The appointment is full time.

Participant Stipend

The participant will receive a monthly stipend commensurate with educational level and experience.

Citizenship Requirements

This opportunity is available to U.S. citizens, Lawful Permanent Residents (LPR), and foreign nationals. Non‑U.S. citizen applicants should refer to the Guidelines for Non‑U.S. Citizens Details page of the program website for information about the valid immigration statuses that are acceptable for program participation.

This program, administered by ORAU through its contract with the U.S. Department of Energy to manage the Oak Ridge Institute for Science and Education, was established through an interagency agreement between DOE and FDA. The participant will receive a monthly stipend commensurate with educational level and experience. Proof of health insurance is required for participation in this program. Participants do not become employees of FDA, DOE or the program administrator, and there are no employment‑related benefits.

Completion of a successful background investigation by the Office of Personnel Management is required for an applicant to be on‑boarded at FDA. OPM can complete a background investigation only for individuals, including non-US Citizens, who have resided in the US for a total of three of the past five years.

Qualifications

The qualified candidate should be currently pursuing or have received a master's or doctoral degree in the one of the relevant fields.

Point of Contact

Ashley

Eligibility Requirements

2 )

• Degree: Master's Degree or Doctoral Degree.
• Discipline(s):
  • Computer, Information, and Data Sciences (
  • Databases, Information Retrieval, and Web Search
  • Scientific Computing and Informatics
• Life Health and Medical Sciences (6 )
  • Mathematics and Statistics (1 ) Affirmation I am a U.S. citizen, or I have lived in the United States for at least 36 out of the past 60 months. (36 months do not have to be consecutive.)