New Associate Director role available with pharma client in NJ. Please email me at [email protected]<mailto:[email protected]> for more info The Associate Director, Clinical Pharmacology position will support the clinical pharmacology programs for an expanding portfolio of products across several disease areas. This role will independently execute routine clinical pharmacology tasks with minimum supervision and may include oversight of vendors and/or contractors. Responsibilities:
* Represent Clinical Pharmacology and provide PKPD support. * Lead the analysis, interpretation, integration and reporting of clinical pharmacokinetic & pharmacodynamic data * Conduct PK/PD analyses to guide development decisions on project teams * Provide PKPD input for regulatory submissions such as briefing documents, IND, CTA and NDA * Prepare appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data * Preparation of abstracts and manuscripts for publication * Closely partner with Research, Clinical functions, Regulatory, Project Management, and other R&D functions. Qualifications: * PhD in Pharmacokinetics, * Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience * Minimum of 5 years of experience in the pharmaceutical industry * Solid working knowledge of pharmacokinetics and modeling, PKPD principles, ADME concepts, and clinical pharmacology * Working knowledge of pharmacokinetic, modeling and data visualizations software * Strong communication skills (verbal and written) and presentation skills are required * Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential [cid:[email protected]] Brenda Roseberry Division Manager-Scientific Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers 720-328-9526 - Office 315-415-4353 - Mobile (preferred) 720-475-1176 - Fax [cid:[email protected]] <https://www.linkedin.com/in/brenda-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=true>
