UCSF

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, clinical pharmacology and pharmacometrics, machine learning, and real-world evidence (RWE).

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. The fellow will spend the first year at UCSF or Stanford, and the second year at the FDA. At the end of two years, the fellow will complete an additional year (after completion of the academic and FDA rotations) at Gilead Sciences. Throughout the fellowship, the fellow will be paired with a Gilead scientist who will serve as a mentor. The anticipated start date of the first year fellowship in academia will be Fall 2021. 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. In addition to research, the fellow will enroll and successfully complete the UCSF-Stanford CERSI Immersion Course in in Drug Discovery, Drug Development, and Regulation. The fellow is also expected to actively participate in all CERSI seminars, meetings and events.

Immersion Experience at FDA (3-12 months)

During the second year, the fellow will be assigned a FDA mentor and will work on a regulatory science research project under the mentorship of a FDA scientist, either remotely or on-site at the FDA in Silver Spring, MD. This project may be a continuation of the fellow’s academic research project, or a new FDA project. We will discuss research project interests with the fellow during his/her first year. The fellow will have an opportunity to attend seminars and workshops held at the FDA to augment the learning experience on different aspects of regulatory science. Furthermore, the fellow is required to attend the annual UCSF-Stanford CERSI Innovations in Regulatory Science Summit.

Immersion Experience in Industry (1 year)

At the end of two years, the fellow will complete an additional 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 at Gilead do not guarantee job placements.

Eligibility Criteria

Applicants must hold a doctoral degree (PhD in pharmaceutical sciences, chemical and biomedical engineering, applied mathematics, or biomedical sciences or another related field, or hold a PharmD). The candidate must have an excellent record of academic achievement. As the Fellow will perform work at the FDA, all candidates must be a U.S. citizen 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.

Application Process

Applicants are to submit items 1-6 of the required documents in the order listed below as a single PDF via email by August 1, 2021 to [email protected]. The PDF filename should follow this format: “LastName_CERSI/Gilead Fellowship Application.pdf”.

The following documents are required for a complete application:

  1. Application cover page containing: applicant’s full name, highest degree obtained (and date), degree granting institution, current institutional affiliation, email address, cell phone number, and complete mailing address.
  2. Statement of interest (1,000 word maximum) describing 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.
  3. Curriculum vitae (5 page maximum)
  4. Scientific publications or other writing samples (submit up to 2 publications). Applicant should indicate their role in the samples provided (i.e., primary drafter or other 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.
  5. One letter of reference from the current research advisor to be submitted directly via email to [email protected] and must be received by the application deadline.
  6. Names of two additional references with 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. The UCSF-Stanford CERSI/Gilead postdoctoral fellowship in regulatory science is supported in part by Gilead Sciences.