Senior Medical Director

hace 3 semanas


Barcelona, España AstraZeneca A tiempo completo

Senior Medical Director, Clinical Development Sciences Location: Boston, MA This is what you will do: The Senior Medical Director, Clinical Development Sciences may lead the clinical subteam or support the clinical subteam and the global program team to build global clinical development plans and contributes to the development of asset level and therapeutic area strategies. Responsible for overseeing the clinical development strategy development and execution for 1 program, leading the clinical subteam to the GPT and represents clinical development on the GPT, contributing to the development of regulatory strategy, and representing the clinical program at regulatory meetings. May supervise 12 direct reports (Medical Directors for the program studies and/or Clinical Development Scientists) or provide medical oversight. You will be responsible for: Lead or support the clinical sub team and oversee the design and execution of multiple clinical studies or clinical programsRepresent Clinical Development on the Global Program Team (GPT) and in presentations at management and review committees (e.g., Clinical Document Review Committee, Development and Commercial Steering Committee)Supervise and develop Medical Directors and CDS and/or fellows; May lead a clinical subteam and oversee the preparation of a clinical development strategy.

As is typical of an officebased role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; problem solve; engage in complex and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours We would prefer for you to have: Board Certification Preferred: Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.5+ years of industry experience in clinical development is preferredExperience for medical responsibilities on a crossfunctional team preferredBasic statistical knowledge preferredUnderstanding of general (and specific) therapeutic principlesExperience designing and executing industrysponsored clinical trialsBroad experience in the principles of clinical trial methodology, statistics, data analysis and interpretationExpert in scientific literature searches and weighing of quality peer reviewed dataExperience authoring study essential documents, Clinical Study Reports, and regulatory documentsStrong relevant therapeutic area experienceAbility to clearly communicate to internal and external stakeholders orally and in writingExperience interacting with varying levels of internal/external management and/or academicians and/or clinicians and/or scientists, etc.Strong business acumen: including indepth knowledge of the multidisciplinary functions involved in a companys drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best endresultsAbility to prioritize multiple tasks and goals to ensure completion in a timely manner within budgetAbility to think both strategically and tacticallyAdvanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data5+ years of industry experience in clinical development



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