Sr. Director, Clinical Science (Oncology)

Primary Responsibilities

• Creates required clinical trial documents including clinical protocols, investigator brochures, DSURs and clinical modules of the IND (in concert with Study Medical Directors)
• Works closely with Clinical Operations to execute the clinical trial with high quality and according to timelines
• Performs ongoing review of clinical data, query generation/resolution and data analysis, including review of draft listings to support data cleaning and interpretation
• Provides scientific expertise to Clinical Operations by responding to questions and/or by clarifying issues arising during study conduct
• Provides internal safety monitoring for clinical trials in collaboration with the Study Medical Director
• Develops and maintains relationships with clinical trial investigators and therapeutic area key opinion leaders
• Leads review of study data (e.g., tables, listings and figures and emerging bioanalytical data) and develops CSRs, clinical presentations and publications
• Supports other members of Clinical Development and Regulatory Affairs departments as required
• Participates as a standing member of multidiscipline Project Teams

Education/Experience/Skills

• BS degree in life sciences; PhD, RN, PharmD or MS preferred and a minimum of 15 years of directly relevant pharmaceutical industry experience in clinical development
• A minimum of 4 years’ experience of focus in assigned therapeutic area
• Experience as a clinical scientist responsible for data review, safety monitoring, protocol development, supporting data analyses, interpretation and publications
• Strong, hands-on working knowledge of drug development, and experience working on cross-functional clinical trial teams and liaising with study investigators
• Prior experience with translational medicine/early phase clinical trials, monoclonal antibody biologics/immunotherapy, and relevant tasks throughout the entire study life cycle, from study concept to database lock and CSR