Associate Director Clinical Pharmacology - (Job Number: 0802889)

Associate Director Clinical Pharmacology - (Job Number: 0802889) DescriptionJohnson & Johnson Pharmaceutical Research & Development, a member of Johnson and Johnson's Family of Companies, is recruiting for an Associate Director Clinical Pharmacology, located in La Jolla, CA.Johnson & Johnson Pharmaceutical Research & Development, L.L.C., La Jolla, develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, metabolic disorders, inflammation disorders and pain. As Associate Director Clinical Pharmacology you are responsible for developing and directing clinical pharmacokinetic (PK) and clinical pharmacology (PD) activities, deliverables, and programs for products in early and late stage clinical development. Responsibilities of this position may include functional organization and management of individuals supporting drug development programs. Responsible for the proactive development, alignment, integration, and implementation of the clinical PK and PD development plans in support of the overall early and/or late development project(s). This also includes responsibility for initiating functional "challenge" and "review" of such plans. Manage the consistency, quality, compliance, and timelines of clinical PK and PK/PD input into Phase I to IIa protocols, PK and PK/PD analysis, and PK and PK/PD sections of investigator brochures, study reports, regulatory documents, and other documents in accordance with general company standards, internal and external guidelines, and processes. Active participation in Clinical Teams/Compound Development Teams. Provide direction to the PK/PD Program Manager (LD) in the PK/PD Working Group or other implementation teams, and to the PK/PD Scientist. Integrate discovery, pre-clinical and clinical data into clinical plans by using appropriate modeling and simulation tools, in conjunction with AM&S Scientists and other functional experts. Contribute to the identification, characterization and validation of potential biomarkers and/or surrogate markers and measurements in non-clinical and clinical studies and to the selection of Discovery NME candidates and of compounds stated to transition into early or late-stage development. Finally, contribute to the development of new concepts, technologies, and designs of preclinical and clinical PK and PK/PD studies. The successful candidate will have a PhD in Pharmaceutical, Medical or Biology Sciences, with a minimum of 3 years of industry experience or an equivalent Master degree with 5 years of relevant industrial experience. Knowledge on clinical drug development and a demonstrated knowledge of pharmacokinetics and pharmacology is needed. Working knowledge of pharmacokinetic/pharmacodynamic software (WinNonlin, NONMEM, Clinical Trial Designer). Experience in the application of PK/PD concepts in a therapeutic area would be a plus. Ability to effectively communicate to individuals and groups at various levels in the organization. Strong focus on delivering on the organizational objectives, proactively taking appropriate action, and seeking opportunities to improve the value delivered to the organization. You are able to build and maintain effective working relationships inside and outside the department and to work in a cross-functional team environment. Ability to diagnose issues and problems, develop alternative solutions, take decisions, and act with a sense of urgency. Understand and effectively use knowledge of emerging scientific and technological developments to successfully work with partners and internal customers. An in-depth understanding of the pharmaceutical science landscape and an eagerness to optimize that knowledge to improve the drug research and development process. Ability to work under pressure and to control the job by planning and prioritization are important. Ability to travel domestically and internationally, dependent on the project activities, approximately 10% is required. Apply Now