Associate Director

Sanofi-Synthelabo and Aventis Pharmaceuticals, part of the sanofi-aventis Group are facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.Responsible for successful implementation and operational aspects of Phase I to III clinical studies in the United States. Direct/lead the Team to ensure successful completion of US Phase I, II and III clinical trials in a timely, ethical and a scientifically responsible fashion. Evaluate feasibility of, and direct a program of Phase I, II and III clinical research involving products leading to the filing of an NDA. This entails reviewing protocols and supervising the conduct of clinical studies in adherence of sanofi-aventis SOPs, as well as institutional and governmental regulations in the United States. Ensure training of USCRU team regarding the product, the pathology, theregulatory environment, the proctocol and the CRF. Maintain a network of experts and potential investigators within his/her thapeutic field. Identification and evaluation of investigators. Medical representative responsibilities: SAE, narrative summaries; active collaboration with the corresponding clinical operations department; presentation of the trial, presentation of trial results, provide answers to questions of a medical nature; participation in important congresses or events concerning the therapeutic field.Evaluation of the feasibility in his/her country of clinical trials proposed by SA: Evaluate the synopsis; collect information and documentation conerning the proposed study that will help determine its feasibility and provide support for the eventual go/no-go decision; formalization of a commitment to objectives set, in terms of number of patients and investigating centers and delays for study conduct.Maintaining anetwork of experts and potential investigators within his/her therapeutic field; identify potential investigator's site competence and their capacity to respect the trial commitments; approve site selectionDirect/lead the Team that is conducting US Phase I, II and III clinical trials in a timely, ethical, and a scientifically responsible fashionPresentation of the trial, presentation of trial results, provide answers to questions of a medical nature. Participation in important congresses or events concerning the therapeutic field. Serve as a medical monitor for these trials and be responsible for the ongoing review of these trials and of the projects as regards US regulations in particiular.Review SAE, narrative summaries, Interact with the pharmacovigilance department to ensure that serious adverse events, involing this US clinical development, are followed up, evaluated, reported to regulatory authorities (FDA) and notified to US Investigators promptly.Ensure that all activities under his/her direction comply with sanofi-aventis' Clinical Development Standard Operating Procedures (SOP's), Good Clinical Practice and US Regulations.Provide appropriate mentoring on the drug development process, and provide assistance with the career development of team members and reportees.
REQUIREMENTS
This position requires an individual with a strong understanding of medical practice as well as the scientific research process. Strong verbal and written skills are required. The ability to interpret clinical data accurately is essential. Eagerness to commit to the completion of tasks within an aggressive but realistic time frame is essential. Ability to function in a transatlantic pharmaceutical research environment is essential.Medical degree; Board Certification or Board Eligibility, or relevant medical subspecialty. At least 1-3 years clinical research experience in pharmaceutical setting or equivalent; demonstrated in communication and personal interaction. Ability to interact in a transatlantic research setting.Desirable Skills