Scientific Director, Clinical Pharmacology, Oncology Job

Company Name:
Janssen Research & Development, LLC. (60
Spring House, PA, US
Scientific Director, Clinical Pharmacology, Oncology
Janssen Research & Development, L.L.C., a Johnson & Johnson Company, is hiring a Scientific Director Clinical Pharmacology in the Oncology therapeutic area to be located in Spring House, PA.
Janssen Research & Development, L.L.C. develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, Janssen Research & Development, LLC is proud to be an equal opportunity employer.
The Oncology Clinical Pharmacology Scientific Director will function as a Clinical Pharmacology leader in support of oncology biologics development. Provide strategic directions and visions on PK/PD modeling to support study designs, compound development plans, and regulatory submissions. Conduct PK/PD data analysis including advanced population PK/PD modeling and simulation and/or disease modeling. Contribute to the clinical pharmacology sections of relevant documents, such as clinical study protocols, clinical study reports, investigator's brochures, summary documents of the eCTD regulatory submissions, and the annual IND updates. Play an active role on cross-functional project teams as a Clinical Pharmacology representative on Compound Development Teams. Responsible for collaborations and interactions with different functions groups (clinical research, biostatistics, programming, toxicology, regulatory affairs, MBDD, biologics research, etc) within the company and regulatory agencies.
A doctorate (PhD) or equivalent in Pharmaceutics, Pharmacokinetics or related field is required. A minimum of 10 years of pharmaceutical development experience required. In-depth knowledge of Oncology clinical development, clinical pharmacology, and pharmacokinetic/pharmacodynamics is required. Experience in participating cross-functional teams and understanding of the Oncology therapeutic area is required. Advanced experience in preparation of pharmacokinetic and clinical pharmacology sections for regulatory submission documents (i.e., INDs, NDAs, BLAs, etc.) is preferred. Must have experience with one of the following PK/PD software applications: WinNonLin, NONMEM, Clinical Trial Simulator, Adapt, SPLUS, or other relevant ones. Experience in biologics clinical development is a plus. Project Management experience is preferred.
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Primary Location:
North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Job Function:
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