The first regulatory science and innovation center on the West Coast
UCSF-Stanford CERSI/Gilead Postdoctoral Fellowship in Regulatory Science
Overview
In the past decade, a plethora of new healthcare products have been developed, including innovative drugs for rare diseases, genome and cell-based therapies, mobile health products and implantable devices. Corresponding to the surge in these innovative products, there has been a scarcity of well-trained individuals to expertly evaluate them for safe and effective use. In fact, regulatory agencies such as the FDA as well as medical product developers have a shortage of highly trained individuals with knowledge of a broad spectrum of regulatory sciences.
The educational mission of the UCSF-Stanford CERSI is to train a new generation of scientists by providing opportunities to broaden their knowledge about tools, methods, and standards to support regulatory science and medical product development.
The UCSF-Stanford CERSI/Gilead postdoctoral fellowship is an experiential program that will provide the most outstanding postdocs an opportunity to conduct research at UCSF/Stanford, FDA and Gilead in fields such as biomarkers, diagnostics, molecular epidemiology, real-world evidence (RWE), clinical pharmacology, pharmacometrics, quantitative systems pharmacology, physiologically based pharmacokinetic modeling, or machine learning.
Training Components
Our objective is that the fellow should have a sufficient foundation and breadth in his/her training to engage in and serve as an ambassador for regulatory science research and education. The fellow will receive a monthly stipend commensurate with education level and experience. In general, fellows will spend the first year at UCSF or Stanford, and the second year at Gilead Sciences, though the fellowship may be extended for a total of three years. The anticipated start date of the first-year fellowship in academia will be on or around July 1, 2025.
The fellowship components are:
Research and Training at UCSF (1 year)
During the first year, the fellow is expected to spend at least 90% of his/her time on a scientific research project under the mentorship of a UCSF or Stanford faculty member. The research project will either extend an existing project or will be an entirely new one-year project. Many of these projects are collaborative research projects with the FDA, so fellows may also gain experience collaborating with FDA scientists. In addition to research, the fellow will enroll and successfully complete the UCSF-Stanford CERSI Immersion Course in Drug Discovery, Drug Development, and Regulation. The fellow is also expected to actively participate in all CERSI seminars, meetings, and events, including the annual UCSF-Stanford CERSI Innovations in Regulatory Science Summit.
Immersion Experience in Industry (1 year)
The fellow will complete a year (after completion of the academic and FDA rotations) at Gilead Sciences, where they will work under the supervision of a Gilead scientist on a research project relating to biomarkers, diagnostics, molecular epidemiology, clinical pharmacology, pharmacometrics, machine learning, or real-world evidence (RWE). The fellow is required to attend the annual UCSF-Stanford CERSI Innovations in Regulatory Science Summit.
Statement of Completion and Employment
Fellows will receive a document certifying their participation in the regulatory science fellowship upon completion of all training components. Please note that the immersive experiences in academia, the FDA, and Gilead do not guarantee job placements.
Eligibility Criteria
Applicants must hold a doctoral degree (PhD in pharmaceutical sciences, chemical/biomedical engineering, applied mathematics, biostatistics, biomedical sciences, epidemiology, biology, bioinformatics, or related fields, or hold a PharmD with lab/clinical investigational experience). The candidate must have an excellent record of academic achievement, with proficiency in mathematics, knowledge of physiological/pharmacological aspects of drugs, and demonstrate a familiarity with data analysis and hands-on experience with data.
An ideal applicant possesses experience working in multicultural environments and strong communication and organizational skills. They also demonstrate the ability to learn quickly and are flexible/adaptable to change.
Should the fellow have the opportunity to rotate the FDA, they must be U.S. citizens or otherwise meet the ORISE Non-U.S. Citizen Requirements (see https://orise.orau.gov/fda/applicants/default.html#immigrant). Applicants may not be current FDA employees, contractors, or fellows.
2024-2025 Application Process
Timeline
| July 1, 2024 | Application filing period opens |
|---|---|
| October 4, 2024 | Application filing period closes |
| Oct-Nov 2024 | Applications reviewed and interviews conducted |
| Dec 2024 - Jan 2025 | Recipients notified |
| July 1, 2025 | Fellowship start date |
How to Apply
Please be prepared to enter the following information:
| Item | Details |
|---|---|
| Personal Information | Name, address, email, phone number. |
| Application Cover Page | The pdf must contain the applicant’s full name, highest degree obtained (and date obtained or anticipated), degree-granting institution, current institutional affiliation, email address, cell phone number, and complete mailing address. |
| Statement of Purpose | (1000 words maximum) Describe the applicant’s professional background and qualifications, regulatory science interests, skills to be acquired, and career goals, including how the fellowship would support those goals. |
| Curriculum Vitae | Upload a file that is 5 pages maximum. |
| Professional/graduate school transcripts | Unofficial transcripts are acceptable. |
| Scientific Publications or Other Writing Samples | (Submit up to 2 publications). Applicant should include a cover sheet preceding the writing samples that describes the samples and the applicant's role. Publications are intended to gauge the research and writing capability of applicants and do not necessarily need to be on the topic of regulatory science. |
| One Letter of Reference |
Must be from the applicant's current or most recent research advisor. Letter writers who wish to submit their letters directly may email them to Holly Ly ([email protected]). |
| Names of two additional references | Must provide full name, title, affiliation, and complete contact information. |
Selection Process
Applications will be reviewed by UCSF/Stanford faculty and Gilead scientists.
UCSF will be the home institution for all fellows.
Learn more
Attend one of our fellowship webinars to:
- Learn more about our fellowship opportunities.
- Hear answers to common questions.
- Connect with current and former fellows.
The UCSF-Stanford CERSI/Gilead Postdoctoral Fellowship in Regulatory Science is supported by Gilead Sciences, Inc.
Contact
Please email Holly Ly ([email protected]) with any questions.