New Jersey Director of Clinical Pharmacology role available

Director, Clinical Pharmacology role available-New Jersey-please contact me for more info: [email protected]<mailto:[email protected]> Actively participates and contributes to the study design and reporting of Clinical Pharmacology studies. Provides input into all phases of drug development including, but not limited to, dose finding, dose optimization, exposure-response and pediatric development. Closely interacts with nonclinical and bioanalytical team members for design and execution of first-in-human, mass balance and drug interaction studies. Author or reviewer of Clinical Pharmacology submission documents and representative of the department at different product development team meetings. Works closely with Modeling team members to provide input on modeling and simulation activities. Interacts with early development, business development team members as well as external collaborators to assess/lead development and selection of pre-IND assets. Job Responsibilities * Development and review of protocol outlines, protocols, pre-study, during study and post-study clinical activities * PK and PK/PD study design, analysis and reporting, including Executive Summaries for PK and PK/PD studies. * Work with pharmacometricians on Population PK/PD design, analysis and reporting * Development of relevant sections for regulatory filings including Annual updates, IB updates, Investigational New Drugs and New Drug Applications * Authoring, review and defense of regulatory submissions * Works with Bioanalytical team members on design and execution of first-in-human, mass balance and drug interaction studies, selection of biomarkers * Works with formulation development groups * Manages Clinical Pharmacology activities including: * Providing input into project budgets including annual and quarterly budgeting/forecasting. * Manages outsourcing of PK and PK/PD analyses and reports, including contract requisition, SOW and approval of invoices. Education and Related Experience PhD in Pharmacokinetics, Clinical Pharmacology, Pharmacology, or a related area with 7+ years of experience in these areas. PharmD with relevant experience considered Requires a depth of knowledge in clinical pharmacology including pharmacokinetics, pharmacodynamics, drug metabolism, biopharmaceutics, and bioanalytical chemistry. * Working knowledge of Phase I clinical operations, pharmacometrics, general pharmacology, pharmacogenetics, and regulatory requirements related to clinical pharmacology. * Knowledge of nonclinical requirements and bioanalytical assays for clinical trials * Working knowledge of formulation development, drug development, PK/PD modeling and simulation. * Understanding of the company's products and the pharmaceutical industry in general. * Familiarity with pharmacogenomics in drug development. * Keeps refreshed of the latest developments in clinical pharmacology. * Must be able to apply scientific knowledge (in the areas specified above) to further the company's products, anticipate and identify core problems, apply insightful analysis, and solve problems effectively. * Strong organization and communication skills. * Experience with regulatory submission process (IND, NDA, MAA) * Hands-on experience with modeling and simulation software (R, NONMEM, Phoenix NLME, Monolix) desirable. * Flexibility to react rapidly to changing situations/environment [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile 720-475-1176 - Fax [cid:[email protected]] http://www.linkedin.com/profile/view?id=19937880&authType=name&authToken=b5d_