Senior Medical Director, Oncology (UK/Europe) - IQVIA Biotech.
We're looking for a candidate to fill this position in an exciting company. Functions as project team memberProvides medical and scientific input to clinical research programs including review of new business proposals, preclinical and/or clinical data, study protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plan designs, clinical study reports, regulatory approval submissions, serious and non-serious adverse event evaluation and reportingEnsures medical activities run according to GCP and operate with highest efficiencyEstablishes and maintains a network of medical/scientific consultants, etc.Supervises and manages Medical Director activitiesClinical Activities:Interacts with clients regarding drug development programs, study design and protocolReviews and provides input for protocol development. Interacts with key thought leaders and/or sponsor representatives to develop inclusion/exclusion criteria and study endpoints. Interacts in team approach to develop statistical and data management sections of the protocol. Reviews the final protocol for clinical, safety and efficacy variables.Provides project team training on protocol and/or therapeutic areasAssists team with developing criteria for investigator site selection and networking for potential investigators for study participation. Aids in review and final selection.Participates in subject recruitment and retention activities including individual calls to key opinion leaders, investigators and site staff and/or participation in teleconference and WebEx presentationsPresents protocol and/or safety reporting information at investigator meetingsDevelops project medical monitoring plans as requestedProvides on call coverage for protocol queries and site support. Provides first line contact for investigators and monitors regarding study related medical/safety issues and resolution of study protocol and pa...