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AstraZeneca: Director Physician - Early Ria

Company: AstraZeneca
Location: Gaithersburg
Posted on: November 23, 2020

Job Description:

Overall accountable for the design of the clinical program including all clinical studies up to Ph3ID and overall responsibility for the scientific & medical strategy as a disease area expert. Providing input to the Target Product Profile (TPP) & line of sight for compounds under development.The Director Physician will deliver to the project team the Medical Scientific strategies of the Clinical Development Plan (CDP). If nominated Medical Science Director he/she has accountability for the overall clinical risk:Benefit, scientific & value content and delivery of the Medical Science components of the project to time & quality.Responsible for the design, conduct, monitoring, data interpretation and reporting of individual clinical trials. Ensures projects adhere to Good Clinical Practice and regulatory requirements. Will be responsible for acting as a renowned expert in own disease/drug field.Key Accountabilities:Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and the product in compliance with GCPDesigns or manages the implementation of the medical strategy within Clinical Development globallyDevelop clinical evidence for functional relevance of targets in human diseaseSupport qualification of pharmacodynamic/disease markers for early assessment of efficacy.Ensure that clinical input into the Translational Medicine and development strategies and plans receive adequate peer consultation to assure high scientific qualityMaintains a high degree of understanding and awareness on new and emerging medical developmentClosely follows medical developments within assigned areas and disseminates new information within Clinical Development to transform trends and emerging data into new plansLiaises with the internal and external medical community to follow developments within areas of expertiseMedical Lead for regulatory communication and preparation of higher level documentsEnsures internal and external peer review of potential study/programme designAs available, provide clinical strategic input to in-licensing opportunitiesAs available, line management responsibility for medical directors and medical scientists, delivering the performance management and guiding the professional development of direct reportsSign off the Study Synopsis/Study ProtocolAccountable for the Investigators Broschure (IB)Education, Qualifications, Skills and Experience:Graduate of a recognised school of medicine with an M.D. degree or equivalent, PhD preferred but not essential> 5 years clinical research expertise in relevant therapy area, in designing, monitoring and implementing clinical trials and interpreting trial resultsSpecialty training or board eligibility, preferably in Respiratory and/or InflammationSignificant leadership experience> 5 years Drug DevelopmentExperience with a thorough understanding of pharmaceutical safety, reporting and surveillance processesAt least 5 years early clinical translational research expertise and experience, including experience in designing, monitoring, executing and interpreting clinical trials, with understanding of biomarkers, biostatistics and safety reportingProven teamwork and collaboration skillsTechnical (medical and scientific) experience evaluating targets/agents for in licensing or internal developmentAbility to travel nationally and internationallyOrganize and deliver Advisory Boards with international KOLs A clear demonstration of behaviours of:Truth seeking rather than success seekingAgile responsiveness to scientific dataEmbracing of peer reviewAgnostic to internal-external sourcing

Keywords: AstraZeneca, Washington DC , AstraZeneca: Director Physician - Early Ria, Executive , Gaithersburg, DC

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