Sr. Manager/Associate Director, Clinical Science - Oncology Biotech

Responsibilities: Contributes to developing the program strategy for assigned trials/compounds Author components with the Medical Director and reviewer of clinical and regulatory documents and registration dossiers (i.e., protocol, ICF, IB, safety updates, study reports, regulatory submissions, etc.) to support registration and commercialization of the compound(s) Contributes to the development of eCRFs and eCRFs completion guidelines and provides scientific support for other key data management deliverables (e.g., database lock activities).Lead the development of a medical data review plan, medical monitoring plan, perform ongoing medical data review, and summarize efficacy and safety data for interpretation/analysis Provide input for country/site selection and feasibility assessment and interact with KOLsPrepare charters and coordinate internal/external committee meetings including presentations and discussion with senior leadership Participate in the development and review of study plans and liaise with project teams Prepare presentations for Investigator meetings, site personnel, CRA training, pre-study site visits (SEVs), and site initiation visits (SIVs) Provide input for developing publications in coordination with the Scientific Communications/Publishing department