Job Duties & Responsibilities

Function as the Medical expert for the clinical study teamProtocol development from study concept to final protocolOversight of global clinical trial team(s) on assigned program(s)Collaborate on, or lead where appropriate, the preparation of clinical study related documentsPrepare for and coordinate Investigator meeting planning and execution and/or on-site initiation meetingsLiaise with other functions to enable quality clinical study executionMonitor, clean, analyze and review safety and efficacy data to establish the presence or absence of trends and follow up as appropriatePresentation at academic congresses, investigator meetings and advisory meetingsDevelopment of medical content for regulatory documents and responses, including but not limited to NDAs/BLAs, sNDAs/SBLAs, briefing packages and common technical documentsIndependent data monitoring committee activities

Essential Qualifications

MDPrevious history executing and overseeing clinical trialsSafety medical monitoringProtocol development experienceRegulatory experienceBasic statistical knowledgeExcellent written / oral communication skillsAbility to think strategicallyWillingness to take on new responsibilitiesInterest in career progression and ability to take on additional responsibilities

Preferred Qualifications

Internal Medicine, CardiologyHistory of academic clinical or basic science researchPublication in peer reviewed journalsIndustry experience a plus but not required 

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.