Program Overview

Overview of the UCSF-Stanford CERSI/Gilead Postdoctoral Fellowship in Regulatory Science

The UCSF-Stanford CERSI/Gilead postdoctoral fellowship is an experiential program designed to provide outstanding postdocs with the opportunity to conduct research at UCSF/Stanford, FDA, and Gilead in various fields, including biomarkers, diagnostics, molecular epidemiology, real-world evidence (RWE), clinical pharmacology, pharmacometrics, quantitative systems pharmacology, physiologically based pharmacokinetic modeling, or machine learning.

Training Components

The fellowship components include:

• Research and Training at UCSF (1 year): The fellow is expected to spend at least 90% of their 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. Applicants may not be current FDA employees, contractors, or fellows.

Application Process

The application process requires the following information:

• 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.
• 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. This fellowship is open to all who meet academic, professional, and interest criteria. UCSF does not use race, gender, sex, or other protected categories or proxies for protected categories in the selection process.

UCSF will be the home institution for all fellows.