Wanted: Clinical Research Scientist - Pharmacology, Cambridge MA

Clinical Research Scientist - Pharmacology Reporting to the Director of Clinical Pharmacology, the Clinical Pharmacologist will be responsible for leading scientific and strategic planning, internal and external project communications, and clinical documentation for NDA-directed clinical development programs for Idenix's drug candidates with an emphasis on clinical pharmacology studies.. Primary Responsibilities: * Design Phase I studies and clinical pharmacology components in Phase II-IV trials. Design clinical pharmacology components (pharmacokinetic and pharmacodynamic) of clinical trials in all phases of development. * Analyze data, interpret results, and first-author clinical pharmacology-related clinical documentation, including: clinical protocols; study reports; abstracts and manuscripts; presentations; clinical pharmacology components of investigator brochures, other IND and NDA documents; and various other internal and external documents and communications, as needed. * Working with Clinical Operations, help develop the operational strategies for clinical pharmacology studies and development programs - investigator selection, CRO selection, budgets, etc. * Help manage program timelines for clinical pharmacology components and related matters; and help manage budgets to meet or exceed time, quality and fiscal objectives. * Assure cross-functional alignment for Clinical Pharmacology studies and activities with other functional areas involved in clinical development programs, within Idenix and at intercompany interfaces. Requirements: * Minimum requirement: Pharm.D. or Ph.D. in clinical pharmacology, pharmacokinetics, biopharmaceutics or a related field) with 2 or more years of industry experience is strongly preferred. * A thorough command of pharmacokinetics and pharmacodynamics and their integration in the clinical drug development process is essential. The candidate must have demonstrated expertise in the design, analysis and reporting of clinical pharmacology studies. The candidate must be competent in the use of industry-standard PK and PK/PD software for noncompartmental, modeling and population-PK and PK/PD analyses and simulation. * Substantial technical writing experience is essential - documented first authorship of protocols, study reports, regulatory communications, manuscripts, etc. IND and NDA submission experience is preferred. * Familiarity with regulatory issues related to Phase I-IV clinical research is essential. * Excellent communication (verbal and written), presentation, and organizational skills are essential. * Therapeutic area (anti-infective, anti-viral) training and experience are desirable. * Clinical budget and project management skills are desirable. Idenix offers an excellent benefits package including competitive salary, equity compensation, major medical insurance, dental insurance, 401(k) plan participation, and group life and disability insurance. To be considered for this position, please send your resume by email to <mailto:[EMAIL PROTECTED]> [EMAIL PROTECTED] <mailto:[EMAIL PROTECTED]> , or by mail to: Human Resources Idenix Pharmaceuticals 60 Hampshire Street Cambridge, MA 02139 www.idenix.com http://www.idenix.com Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases. Our current focus is on the treatment of infections caused by hepatitis B virus, hepatitis C virus and human immunodeficiency virus. _____________________ This email has been scanned by the MessageLabs Email Security System to prevent the transmission of viruses, spam and other unwanted content.