Centocor R&D, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director in Pharmacokinetics and Pharmacometrics, located in Chesterbrook, PA. Centocor, Inc. develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders.
The Associate Director will function as a Clinical PK/PD leader in support of biologics development. Provide strategic directions and visions on PK/PD modeling to support study designs, compound development plans, and regulatory submissions. Job duties include (1) Conduct PK/PD data analysis including advanced population PK/PD modeling and simulation and/or disease modeling, (2) 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, (3) represent Clinical Pharmacology in cross-functional project teams, and (4) Responsible for collaborations and interactions with different functions groups (clinical research, biostatistics, programming, toxicology regulatory affairs, etc) within the company and regulatory agencies. A doctorate (PhD) or equivalent in Pharmaceutics, Pharmacokinetics or related field is required. A minimum of 8-10 years of pharmaceutical development experience is required, of which at least 5 years should be in clinical drug development. In-depth knowledge of clinical development, clinical pharmacology, pharmacokinetic/Pharmacodynamics, and model-based drug development is required. Must be experienced in representing clinical PK/PD in cross-functional teams and understand the assigned therapeutic area(s). Advanced experience in preparation of pharmacokinetic and clinical pharmacology sections for regulatory submission documents (i.e., INDs, NDAs, BLAs, etc.) is required. Must have experience in population approach in describing pharmacokinetic/pharmacodynamic systems with various types of clinical pharmacology data. Must have experience with WinNonLin, NONMEM, and preferably S-PLUS/R, Trial Simulator, Adapt, or other relevant pharmacokinetic/pharmacodynamic software. Experience in biologics clinical development is a plus. Project Management experience is required. Demonstrated motivation, attention to details, teamwork ability, and communication skills are necessary. We are committed to bringing the most capable candidate on board. Compensation and benefits will be commensurate with the candidate's experience and talent. Interested candidates may send CV to: ~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~* Chuanpu Hu, Ph.D. Director, Pharmacometrics Pharmacokinetics and Pharmacometrics Biologics Clinical Pharmacology Centocor R&D, a division of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. C-3-3 200 Great Valley Parkway Malvern, PA 19355 Tel: 610-651-7423 Fax: (610) 993-7801 E-mail: ch...@its.jnj.com <mailto:ch...@its.jnj.com> ~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*~*
