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UCSF/Genentech Postdoctoral Fellowship in Regulatory Science

Wed, May 13, 2020 12:19 PM | Deleted user

Overview

We are pleased to announce a new fellowship sponsored by UCSF and Genentech, and focused on regulatory science. In the past decade, a plethora of new healthcare products have been developed, including innovative drugs and biologics, 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 develop and evaluate them for safe and effective use. Importantly, there is a new need for individuals who have computational training to apply their skills to the development of drugs, biologics, and medical diagnostics. The educational mission of UCSF in regulatory science 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/Genentech postdoctoral fellowship is an experiential program that will provide the most outstanding postdocs with unique immersion experiences in regulatory science research and drug development in areas such as Clinical Pharmacology and Pharmacometrics.


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, and the second year, when projects are available, the fellow will have an opportunity to train at the FDA. This period of time is flexible, from 3 to 12 months. At the end of two years, the fellow will complete an additional year (after completion of the academic and FDA rotations) at Genentech, Inc. The anticipated start date of the first year fellowship in academia will be on or around August 1, 2020. 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. 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 be expected to complete UCSF-Stanford CERSI courses focusing on regulatory science and drug development and actively participate in UCSF-Stanford CERSI scientific seminars and symposia. Furthermore, the fellow will take part in regularly scheduled networking and mentoring events.


Immersion Experience at FDA (3-12 months)

During the second year, the fellow, under the mentorship of faculty, will seek training opportunities at the FDA through FDA funding mechanisms such as ORISE. The fellow will be paired with a mentor at the FDA and will work alongside clinicians, engineers, or other scientists in regulatory science research with a focus in Clinical Pharmacology and/or Pharmacometrics. The fellow will either continue his/her research project or will be involved in a new project. Research projects interests will be discussed with the fellow during his/her first year. The fellow will have an opportunity to attend seminars and workshops held at the FDA augmenting the fellow’s learning experience about different aspects of regulatory science and drug development. Furthermore, the fellow will be required to attend an annual UCSF-Stanford CERSI symposium in regulatory science.


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 Genentech, Inc. This year will complement and extend his/her training in regulatory science, drug development, Clinical Pharmacology, and Pharmacometrics. The fellow will be assigned a mentor at Genentech, Inc. and will work alongside scientists in the Department of Clinical Pharmacology at Genentech while continuing to be mentored by his/her academic faculty. The mentors will help the fellow design the research project. The fellow will be required to attend an annual UCSF-Stanford CERSI symposium in regulatory science.


Statement of Completion and Employment

Fellows will receive a document certifying their participation in the regulatory science fellowship upon completion of all training components. Immersive experiences in academia and at the FDA do not guarantee job placements.


Eligibility Criteria

Applicants must hold a PhD-level degree in pharmaceutical sciences, chemical and biomedical engineering, applied mathematics, or biomedical sciences or another related field, or hold a PharmD degree. Preferably the candidate has experience of mathematical modeling and simulation in pharmacology or biology (e.g. population PK/PD modeling, PBPK, quantitative systems pharmacology, biology) or experience in transporter biology. The candidate must have an excellent record of achievement. Due to the fact that 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 (https://orise.orau.gov/fda/applicants/default.html#immigrant). If the Fellow is not approved for a rotation at FDA, intense didactic courses and other training in FDA regulatory sciences will be arranged during the first year training at UCSF. Applicants cannot 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 Monday, June 15, 2020 to Lawrence.Lin@ucsf.edu. The PDF filename should follow this format: “LastName_UCSF/Genentech Fellowship Application.pdf”.

The following documents are required for a complete application:

  1. Application cover page stating: Applicant’s First and Last Name, Highest Degree, Degree Granting Institution, Current Affiliation, Email Address, Phone Number, Street Address, City, State/Country, Postal Code.
  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 authorship 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 Lawrence.Lin@ucsf.edu 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 faculty and Genentech scientists.

The UCSF/Genentech postdoctoral fellowship in regulatory science is supported in part by Genentech, Inc.


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