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Associate Director, Clinical Development - Hematology/Oncology Dublin Ireland,
Posted on : 05 April 2017
Jazz Pharmaceuticals is seeking a clinical development associate director to join a team in hematology oncology drug development. You will be responsible for development of international clinical studies, the oversight and interpretation of clinical trials data, clinical interactions with multidisciplinary groups across the company including R&D, commercial, regulatory and business development, and with external stake-holders including regulatory agencies and thought leaders.Essential FunctionsProvide clinical/scientific input during the development, execution and completion of clinical trialsInterpret clinical trial data and prepare reports, regulatory submissions and publications based on the resultsMonitor clinical trials for safetyLead preparation of clinical portions of all relevant regulatory filings (IND, NDA, MAA, etc) and review sections from other functional areasDevise strategy for development and implementation of clinical studies for both investigational medicines and new indications for approved medicinesWork closely with other functional areas within R&D (clinical operations, data management, biostatistics, clinical pharmacology, preclinical) to facilitate the execution of clinical trials and programsDevelop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjuction with project team members, regulatory affairs and senior managementServe as medical representative with regulatory agenciesIdentify and interact with key opinion leaders and academic organizations to assure incorporation of latest clinical thinking and guidelines into clinical development plansLead clinical advisory board meetings to obtain strategic input into clinical program developmentServe as medical resource for clinical issues raised by internal and external collaborators, investigators, consultants, business development and investor contacts. Required Knowledge, Skills, and Abilities Pharmaceutical development experience, preferably in hematology/oncology, or completion of specialty certification in hematology/oncologyDemonstrated scientific and therapeutic expertiseExcellent written and verbal communication skills and proven ability to work in an international collaborative environmentAbility to work effectively in cross functional teams and successfully leverage internal and external partnershipsExcellent organizational and time management skills, ability to lead and manage multiple complex projectsDemonstration of Jazz values in previous employmentAbility to work proactively and effectively, with creative problem solving skillsTravel up to 10%-20% of the time Required/Preferred Education and LicensesMedical degree, MD or equivalent (DO, PharmD, PhD), with experience in hematology/oncology Description of Physical DemandsOccasional mobility within office environment.Routinely sitting for extended periods of time.Constantly operating a computer, printer, telephone and other similar office machinery. Description of Work EnvironmentWork indoors in normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes.Frequent computer use at workstation.May move from one work location to another occasionally.Responsibilities may require a work schedule that may include working outside of “normal” work hours, in order to meet business demands.Occasional public contact requiring appropriate business apparel.
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