Day One Biopharmaceuticals
Cancer drug development comes of age.
Oncology • Cancer • Drug Development • Biotechnology • Pediatric Oncology
11 - 50
Director, GCP Quality Operations
August 24
🏡 Remote – Anywhere in California
Day One Biopharmaceuticals
Cancer drug development comes of age.
Oncology • Cancer • Drug Development • Biotechnology • Pediatric Oncology
11 - 50
Description
• Provides expertise and leadership in Good Clinical Practice Regulations (GCP) • Assurance of patient safety and data integrity • Designated point of contact for dedicated clinical trial projects and/or program teams related to respective clinical quality activities
Requirements
• Bachelor’s degree or equivalent experience in life sciences or quality required; Advanced academic qualification/degree preferred • Equivalent relevant professional experience will be considered. • 10+ years R&D experience or relevant experience in science and clinical research, ideally with supporting clinical/regulatory/medical affairs, quality management, translational sciences, clinical development; equivalent experience • 10+ years of GLP/GCP/GVP quality risk management and/or quality assurance experience • 5+ years of experience in working with and directly communicating with senior leaders with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities • Proven ability to function autonomously in a matrix model and in a team environment • Proven ability to think creatively and to develop and execute strategic plans • Travel Required: up to 25% • Able to communicate complex information and analyses to a variety of scientific and non- scientific audiences in both verbal and written formats • Works seamlessly with other cross-functional departments to include commercial organization and manufacturing organizations
Benefits
• Competitive benefits
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