Associate Director, Clinical Science

Role SummaryThe Associate Director Clinical Scientist contributes to the execution of the clinical development plan for the candidate drug products in collaboration with Project Leaders and Medical Directors. The clinical scientist will be involved in operationalizing studies, monitoring data in real time to ensure the integrity of the study and proactively identifying issues in the conduct of trials. They will also be responsible for medical review and data analysis for the purposes of both data cleaning and interpretation for regulatory documents and publications. They should be comfortable working in a multidisciplinary environment with frequent coordination between clinical operations, data management, biostatistics, regulatory, commercial, medical affairs, clinical pharmacology, translational medicine, and medical functionsKey ResponsibilitiesMonitoring of clinical data: 35%             Perform high level clinical data review for quality and patient safety on an ongoing basis and escalate issues to the medical director as appropriate.Work collaboratively with data management, clinical operations, and medical monitors to ensure clinical data review is performed efficiently and in alignment with the needs of the trial.Communicate and escalate issues both internally and to investigators as appropriate.Work closely with the cross functional team on EDC builds according to the protocol specifications.Generation and review of study documents: 20%Participate in authoring clinical documents including concept sheets/decks, clinical study protocols, investigator brochures, and regulatory documents.Preparation of clinical outputs: 20%Generation of clinical outputs and initial interpretation for internal purposes and key external interactions including but not limited to investigator and DMC meetings.Work closely with Biostatistics, Pharmacovigilance and other stakeholders to review study outputs such as Tables/Listings/Figures and SAP updates.Study team and site communication: 25%Prepare for and participate in regular study team meetings representing the interests of clinical developmentOrganize and present data, study designs, and other information to advisory boards, investigator meetings, site interactions, study committees, and other internal and external settings.Other duties and responsibilities as assigned.