Scientist-Clinical Pharmacology ( ADC)
Who We Are
At the Roche Group, about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, Genentech has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about Genentech, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
The Position
The Clinical Pharmacology Department at Genentech, Inc. is seeking aPh.D. level scientist who is driven to understand the Clinical Pharmacokineticsand Pharmacodynamics of novel drug candidates in the area of Oncology. This individual will lead and support Clinical Pharmacology activities ofAntibody Drug Conjugates across all phases of clinical development. Thisperson will have responsibility for the Clinical Pharmacology Strategy toensure that appropriate dose/route/schedule decisions are made using state ofthe art modeling and simulation strategies that are aligned with projectneeds. This will be accomplishedby working in close partnership with Clinicians, Biostatisticians and projectteams Responsibilities will include planning and reviewing study designs,analysis plans, data analysis, interpretation of PK/PD as well as planning,implementation and organization of regulatory filings (worldwide) andpresentation of data at cross-functional teams, department meetings, conferencesand regulatory meetings (worldwide). Additionally this individual will also bedirectly involved in leading project sub-teams and representing the function atcross-functional project teams.Who You Are
Relevant experience and demonstrated impact on drugdevelopment is expected and experience with both Small and Large Molecules ishighly desired. In addition,experience in the preparation of regulatory applications (IND, BLA, CTD, andEuropean and Asian filings) and good knowledge of GCP and regulatory guidelinesis highly desirable. Leadership abilities are a plus. The candidate must haveexcellent communication skills and the ability to work effectively oninterdepartmental project teams. Familiarity with quantitative approaches in drug development, workingknowledge of modeling software (NONMEM, ADAPT II and WinNonlin) and the abilityto plan, organize, and critically assess and/or perform PK/PD data analyses areessential. External scientificactivities such as presentations at scientific meetings and a strong trackrecord of publications in peer-reviewed journals is highly desired, especiallyfor Senior Scientist candidates.
EDUCATION: A Ph.D. in Pharmacokinetics,Pharmaceutical Sciences, Biomedical Engineering or related discipline with atleast 3-5 years (for Scientist) and 6-10 years (for Senior Scientist) ofindustry and/or post-doctoral experience is required.
The next step is yours. To apply today, click on the "Apply online" button below.
Genentech is an Equal Opportunity Employer.
