Overview
Provide scientific leadership and direction in clinical development programs. Accountable for the development and finalization of study protocols. Liaise with various leads to evaluate key aspects of the study. Provide scientific oversight of clinical studies. Collaborate to ensure regulatory reporting requirements are met. Work closely with study physicians to monitor safety and benefit/risk.Responsibilities
Provide scientific leadership and direction in clinical development programsAccountable for the development and finalization of study protocolsLiaise with various leads to evaluate key aspects of the studyProvide scientific oversight of clinical studiesCollaborate to ensure regulatory reporting requirements are metWork closely with study physicians to monitor safety and benefit/riskQualifications
B.S. OR Masters OR Ph.D. OR Pharm.D.5 plus years of recent drug development experience in a pharmaceutical industry or CRO environmentPrior drug development experience in HIV / infectious diseasesExperience in working with or writing study protocols, informed consent forms and clinical study reportsExperience with reviewing and interpreting clinical and scientific dataExperience contributing to end-to-end clinical development strategyExperience translating complex study-level issues into broader program-level recommendations5 plus years leading cross-functional teamsExperience managing multiple programs concurrently
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