Genentech/Howard Fellowship in Clinical Pharmacology

General Program Mission: 

A world leader in clinical research, Genentech has generated large clinical databases from multiple randomized clinical trials and registries. Genentech believes in the importance of building on this data. Genentech has established the Fellowship to rely on the synergy between Genentech's focus on continued innovation and clinically relevant research and the Fellow's clinical expertise and passion for clinical research. 

Scope of Work:

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 Institution mentors, design and implement a clinical pharmacology and/or modeling and simulation research project(s)
  • Present the results of the research project(s), Institutional, 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-interaction, comparability) 
  • Serve as a Clinical Pharmacology lead on cross-functional project sub-teams (i.e. clinical, pharmacology, biomarkers), 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 clinical documents (e.g. clinical trial protocols, investigator brochures, clinical study reports) 
  • Develop modeling and simulation skills (e.g., non-compartmental, compartmental, pharmacokinetic/pharmacodynamics ("PK/PD"), and population PK modeling
  • Develop an understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use ("ICH"), Food and Drug Administration ("FDA"), European Medicines Agency ("EMA"), and other relevant Clinical Pharmacology guidance and apply relevant guidance in their work 

PROGRAM DESCRIPTION: 

The Fellowship builds on the synergy between the Fellow's broad 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 Genentech Research and Early Development ("gRED") Clinical Pharmacology Department, which is responsible for applying the principles of quantitative pharmacology to enable the 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. These experiences will potentially lead to publications and presentations at scientific conference and give the Fellow exposure to career opportunities in the biotechnology/pharmaceutical industry.