Fellowship in Industry Program — Genentech

This two-year Clinical Science fellowship provides in-depth exposure to Early Clinical Development and understanding the basic principles of clinical research. The fellow will function as a Clinical Scientist and will support Medical Directors/senior-level Clinical Scientists on a diverse set of clinical development activities.

gRED's OMNI (Ophthalmology, Metabolism, Neurology, Infectious Disease, Immunology) organization is responsible for developing and executing early development clinical strategies in healthy volunteers and patients to provide data for gRED non-oncology new molecular entities with respect to safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and the utility of biomarkers.

Activities at Genentech

The fellow will function as a clinical scientist and will support medical directors/senior level clinical scientists on the following activities:

• Serve as a clinical science representative on cross-functional sub-teams (i.e. protocol execution, clinical, biomarkers, pharmacokinetics)
• Create, review and present clinical slides for internal (i.e. Genentech/Roche) and external meetings (e.g. Investigator meetings, scientific congresses, advisory boards, site visits, site staff training)
• Develop understanding of Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), FDA, EMA, NICE and other relevant guidelines and regulations
• Draft abstracts, posters, manuscripts for scientific meetings
• Author and review of clinical documents (i.e. clinical trial protocols, clarifications and amendments, informed consents, investigator brochures, clinical study reports, investigational new drug submissions)
• Respond to inquiries from health authorities (e.g. FDA, EMA) and study site ethics committees
• Partner with the data management team to assist with the development of case report forms
• Serve as a primary point of contact for study inquiries
• Contribute to ongoing review of the integrity of clinical trial data
• Develop understanding of Phase I-II drug development

Fellowship Program Dates

The fellowship begins July 1, 2024 and ends June 30, 2026.

This two-year Clinical Science fellowship provides in-depth exposure to Early Clinical Development and understanding the basic principles of clinical research. The fellow will function as a Clinical Scientist and will support Medical Directors/senior-level Clinical Scientists on a diverse set of clinical development activities.

Genentech's Oncology Early Clinical Development mission is to provide the clinical leadership and skills to successfully develop novel cancer therapies and the means by which to identify the patients who benefit from them. The organization is responsible for developing strategies for and executing on First-in-Human, Phase 1, and Proof-of-Concept oncology clinical trials. In the role of a Clinical Scientist, the fellow will gain experience in the basic principles of clinical oncology research.

Activities at Genentech

The fellow will function as a clinical scientist and will support medical directors/senior level clinical scientists on the following activities:

• Serve as a clinical science representative on cross-functional sub-teams (i.e. protocol execution, clinical, biomarkers, pharmacokinetics)
• Create, review and present clinical slides for internal (i.e. Genentech/Roche) and external meetings (e.g. Investigator meetings, scientific congresses, advisory boards, site visits, site staff training)
• Develop understanding of Good Clinical Practice (GCP), International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), FDA, EMA, NICE and other relevant guidelines and regulations
• Draft abstracts, posters, manuscripts for scientific meetings
• Author and review of clinical documents (i.e. clinical trial protocols, clarifications and amendments, informed consents, investigator brochures, clinical study reports, investigational new drug submissions)
• Respond to inquiries from health authorities (e.g. FDA, EMA) and study site ethics committees
• Partner with the data management team to assist with the development of case report forms
• Serve as a primary point of contact for study inquiries
• Contribute to ongoing review of the integrity of clinical trial data
• Develop understanding of Phase I-II drug development

Fellowship Program Dates

The fellowship begins July 1, 2023 and ends June 30, 2025.

The Genentech Clinical Pharmacology Fellowship program builds on the synergy between the fellow’s comprehensive Doctor of Pharmacy training and Genentech’s innovation in drug development to prepare the individual for a career in the biotechnology/pharmaceutical industry. The fellow will be part of the gRED Clinical Pharmacology Department, which is responsible for applying the principles of quantitative pharmacology to enable selection of a safe and effective dose, route and regimen for small molecules and biologics. The fellow will gain drug development experience at Genentech by completing research projects in clinical pharmacology and/or modeling and simulation and collaborating with scientists across disciplines within Genentech and Roche. These experiences will potentially lead to publications and presentations at scientific conferences and give the fellow exposure to career opportunities in the biotechnology/pharmaceutical industry.

Activities at Genentech

The Fellow will function as a Clinical Pharmacologist and will support research and development projects, which may include the following activities:

• With guidance from the Genentech and University of the Pacific mentors, design and implement a clinical pharmacology and/or modeling and simulation research project(s).
• Present the results of the research project(s) at Genentech, University of the Pacific, a local and/or national scientific meeting and/or publish them in a peer-reviewed journal.
• Serve as a Clinical Pharmacology lead for a healthy volunteer study for a small and/or large molecule project (e.g., food effect, drug-drug interaction, formulation bridging, bioequivalence)
• Serve as a Clinical Pharmacology lead on cross-functional project sub-teams (including clinicians, pharmacologists, biomarker experts, biostatisticians, regulatory experts), facilitating discussions of clinical pharmacology-related issues
• Develop clinical pharmacology plans for small and/or large molecule projects and obtain buy-in from the project team with support from their mentor
• Author clinical pharmacology sections of documents (e.g., clinical trial protocols, investigator brochures, clinical study reports, health authority pre-meeting packages, NDAs, BLAs)
• Develop hands-on modeling and simulation skills (e.g., noncompartmental, compartmental, PK/PD, and population PK modeling)
• Develop an understanding of ICH, FDA, EMA, PMDA and other relevant Clinical Pharmacology guidances and apply them in their work
• Develop an understanding of Phase I-IV drug development in different therapeutic areas

Fellowship Program Dates

The fellowship begins July 1, 2023 and ends June 30, 2025.