Associate Director, Clinical Pharmacology
This individual will be responsible for the Clinical PKPD activities on Small Molecule and/or Biologics in clinical development
Who we are
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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
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The Clinical Pharmacology Department at Genentech, Inc. is seeking an Associate Director who is driven to understand the Clinical Pharmacokinetics and Pharmacodynamics of novel drug candidates in the area of Oncology, Immunology, and/or Neuroscience. This individual will be responsible for the Clinical PKPD activities on Small Molecule and/or Biologics in clinical development. This person will have responsibility for the Clinical Pharmacology strategy in order to ensure that appropriate dose/route/schedule decisions are made using the state of the art modeling and simulation strategies that are aligned with project needs. This will be accomplished by working in close partnership with Clinicians, Biostatisticians and project teams. 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) and presentation of data at cross-functional teams, department meetings, conferences and regulatory meetings (worldwide). Additionally this individual will also be directly involved in leading project sub-teams and representing the function at cross-functional project teams. The position may also include managerial responsibility of Research Associates and/or Scientists.
Who you are
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Relevant experience and demonstrated impact on drug development is expected and experience with Small Molecules or Biologics is highly desired. In addition, experience in the preparation of regulatory applications (IND, NDA/BLA, CTD, and European and Asian filings) and good knowledge of GCP and regulatory guidelines is highly desirable. Leadership abilities and a strong track record in management are a plus. The candidate must have excellent communication skills and the ability to work effectively on interdepartmental project teams. Familiarity with quantitative approaches in drug development, working knowledge of modeling software (NONMEM, ADAPT II and WinNonlin) and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses are essential. EDUCATION:A Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline with at least 8 yrs years of industry and/or related post-doctoral Clinical Pharmacology experience is required. Management experience is required
Genentech is an Equal Opportunity Employer with a commitment to diversity. All individuals are encouraged to apply.
