Clinical Development Manager

Contributes to ViiV Healthcare early- and/or late-stage clinical development programs Leads the development, finalization, and amendments of study protocols with appropriate internal/external stakeholder input while ensuring protocol fulfils strategic objective of clinical development Liaises with Operations, Clinical Pharmacology, Medical, Regulatory and Commercial Leads to help ensure study evaluates key aspects of the Asset Product Profile critical to product differentiation/reimbursement where possible Provides scientific oversight of clinical studies, including assurance that data collection and study analysis plans are aligned with the protocols, thereby allowing for intended scientific interpretation of study data and results Partners with study team to ensure that all regulatory reporting requirements are met Collaborates with physicians and other study team members and stakeholders to enable appropriate review of safety data May assist in identification of safety review committee members and preparation of interim safety review charter document Works closely with study physician(s) to help monitor safety and benefit/risk for studies Works within the study team to help to create evidence generation and scientific outputs including content of investigator meeting, clinical study report, preparation of study results for scientific meetings, congresses, and external journal publications, preparation of regulatory documents, and other relevant study documents Partners with clinical operations colleagues to help ensure optimal delivery of study while maintaining close collaborations with other functions supporting the study Contributes to quality assurance and inspection readiness activities Requirements B.S., Masters, Ph.D., Pharm.D., or MD with 3 plus years of recent clinical drug development experience in a pharmaceutical industry or CRO environment Prior drug development experience in HIV, infectious diseases or other relevant therapy area Experience in working with or writing study protocols, informed consent forms and clinical study reports Experience with reviewing and interpreting of clinical and scientific data 3 plus years contributing to a cross-functional team, including internal and external partners (e.g. 3rd parties, academic partners, and subcontracted organizations) #J-18808-Ljbffr Jobtailor