South San Francisco, CA30+ days ago
Core Competencies, Knowledge, and Skill Requirements: Knowledge of study design, protocol development and study conduct Excellent written and oral communication skills in the negotiation, presentation, and authoring process with relevant cross function team and medical experts Sufficient knowledge of business processes, regulatory, and compliance related to drug development Excellent verbal and written communication skills Ability to effectively collaborate in a dynamic environment Competency in decision making, influencing, and execution in a changing business environment Comfortable with uncertainties through excellent risk management skill. Job Responsibilities: Provide medical oversight for the effective conduct of clinical trials, including: Medical monitoring on clinical development programs Collaboration with other functional areas to participate in design and governance of clinical development plans and study protocols Monitor and review medical data for all clinical trials and represents the sponsor in internal Safety Review Committees Engage with clinical investigators and study site personnel Analyze, present, and interpret data from clinical studies.