Head of Small Molecule PKPD , Genentech

Responsibilities:

The department of Late Stage Pharmacokinetics and Pharmacodynamic Sciences at Genentech is seeking a senior Ph.D. level Associate Director for our Small Molecule Clinical PK/PD workgroup. We need an individual who is driven to understand the PK/PD of exciting and novel drug candidates in the area of Bio Oncology, Immunology and Tissue Growth and Repair. This leader will be responsible for the development and recommendation of novel and state-of-the-art clinical PK study designs and clinical pharmacology strategies with the ultimate goal of the determination of clinical dose/route/regimen for small molecules in clinical practice. The workgroup interacts with scientists across a broad range of functional areas including Chemistry, Biology, Preclinical Safety Assessment, Preclinical DMPK, Pharmaceutical Sciences, PD Biomarkers, Clinical Sciences, Biostatistics, Statistical Programming, Clinical Operations and PK/PD Modeling and Simulation. This individual will serve as a liaison with these groups, enabling the workgroup. Responsibilities will include leading the scientific group, planning and reviewing study designs, analyzing plans and data, assessing study sites and interpreting PK/PD as well as planning, implementing and organizing regulatory filings and presentation of data to cross-functional teams, department meetings, conferences and regulatory meetings. This individual will also be responsible for ensuring that all PK/PD analyses are of the highest quality and meet regulatory/GXP guidelines. Additionally this individual will also be directly involved in initiatives, project teams and technical review committees in a leadership capacity, as well as provide mentoring and guidance for individuals within these teams.

Requirements:

A Ph.D. or equivalent in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences or a related discipline with a minimum of 10-15 years of experience is required. Strong leadership and managerial experiences are highly desirable. Familiarity and experience with Translational Drug Development with molecular targeted agents and the ability to guide in planning, organization and analysis of experimental/quantitative data are essential. The ideal candidate will have experience in the preparation of regulatory applications (IND, NDA, and BLA) and excellent knowledge of GXP and regulatory guidelines. Experience in forming or leading a drug development group or PK/PD group is required. The incumbent must have excellent communication skills and the ability to work effectively on interdepartmental project teams. A proven track record of both scientific achievement and leadership is required.

Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: www.gene.com/careers and reference Req. #1000021321. Please use “Web – BAADME” when a "source" is requested. Genentech is an Equal Opportunity Employer.

Senior Research Associate/RA – DMPK

Responsibilities:

The department of Drug Metabolism and Pharmacokinetics (DMPK) at Genentech is seeking a highly motivated individual to support pharmacokinetic and drug disposition studies enabling the discovery and development of small molecule drugs. The qualified candidate will conduct in vitro permeability and transport studies in support of Discovery and Development projects, as well as develop assays to investigate expression and functions of drug transporters.

Requirements:

A Bachelor’s or Master’s degree in Biology, Chemistry or other relevant fields with a minimum of two years of experience is required. Excellent organization skills, strong verbal and written communication skills and flexibility are essential. Extensive experience in cell/tissue culture and molecular biology techniques is highly desirable. An understanding of pharmacokinetic concepts is a plus.

 
Genentech is dedicated to fostering an environment that is inclusive and encourages diversity of thought, style, skills and perspective. To learn more about our current opportunities, please visit: www.gene.com/careers and reference Req. #1000020035. Please use “Web – BAADME” when a "source" is requested. Genentech is an Equal Opportunity Employer.