Director - Safety Operations
5 hours ago
Description
• Director, Safety Operations overseeing safety operations for Enliven Therapeutics • Remote position in a clinical-stage biopharmaceutical company focused on oncology
Requirements
• Advanced Degree: Minimum of 5+ years of experience in drug safety operations, ideally within the oncology therapeutic area with small molecule experience • Vendor Management Expertise: Proven experience in overseeing and managing safety vendors is essential • Technical Proficiency: Strong expertise in utilizing safety databases and safety coding dictionaries • Global Safety Reporting: In-depth knowledge of international safety reporting regulations and best practices • Regulatory Acumen: Comprehensive understanding of and ability to implement pre- and post- marketing drug safety standards, particularly in oncology • Communication Skills: Exceptional oral and written communication skills, enabling clear and effective information exchange • Team Collaboration: Strong interpersonal skills with a demonstrated ability to work collaboratively within cross-functional teams • Project Management: Ability to manage multiple projects and meet tight deadlines with a high degree of accuracy and efficiency • Strong ethics to approach programs with thoughtful and practical solutions
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