Assistant Director

Position Summary:Responsible for the scientific, clinical and operational management of clinical programs to evaluate, register, and market pharmaceutical agents.  May participate in Medical Affairs and Marketing activities including development, design and implementation of Phase IV studies and/or publications.  May also be involved in product in-licensing.  Must have ability to manage a study program or portions thereof.  May also be involved in supervising and managing study team members, such as Clinical Scientist and Clinical Trial Assistant.  Position Responsibilities:Responsible for implementing the clinical development and clinical trial process from inception to completion. Includes managing study teams and interfacing with other departments and vendors as applicable. * Manage CRO and liase with partner company. * Responsible for managing all aspects of a clinical development program, and for all clinical documents and study and program activities from initiation to final study report.  * Author clinical protocols under direction of Director/Senior Director/Executive Director. * Participate in NDA/sNDA submission activities. * May also participate in development of Clinical Development Plans (CDP). * MDs will be responsible for the medical oversight of the clinical trial or program.  MDs may also function as the Study Physician. * Responsible for creating and managing study budgets for clinical programs. * Responsible for presentation at investigator meetings, partner meetings and internal team meetings. * Oversee in-house site management and study close-out activities.  * Liaise with partner company, help coordinate Advisory Board meetings, and participate in Medical Marketing meetings. * May participate in review of in-licensing drug candidates. * Assist and coordinate scientific due diligence in review of in-licensing drug candidates. * Lead Clinical Team Meetings. * May have two (2) or more direct reports * May serve as a therapeutic area consultant to other in-house teams within Forest Laboratories, Inc. * Participate in the writing and/or presentation of data at professional meetings, and reports for presentation and publication. Education: Advanced degree (Master's, PharmD, PhD, MD) preferably in a health-related field or a bachelor's degree with a commensurate combination of appropriate education and experience Experience: Minimum of 3 years of drug development experience with emphasis on Phase II/III /IV programs.  Experience with development, implementation and completion of clinical trials and/or programs. Experince with pain management, CNS, or rhuematology programs is desired. Experience with preparation of regulatory and study documents.  Leadership abilities and experience managing and coordinating multidisciplinary clinical teams.Knowledge, Skills, and Abilities Strong analytical skills. Ability to work in matrix environment. Excellent written and oral communication skills. Proficiency in basic computer skills. Ability to manage multiple tasks in a timely, budget-conscious manner. Experience in process improvement efforts including task forces and committees. Ability to identify and analyze issues and provide effective solutions.