Global Development Scientist, Director

Role: As Global Development Scientist, Director, lead clinical strategy and execution for hematology oncology trials, focusing on transforming scientific insights into registered therapies. Responsibilities: develop and oversee clinical protocols across early and late phases, provide scientific leadership, lead data review and interpretation, contribute to regulatory submissions, and foster stakeholder collaboration. Manage trial design involving immunotherapy, cell therapy, and targeted agents; ensure compliance with GCP, ICH, and global regulations; and drive cross-functional initiatives to optimize study delivery and quality. Requirements: BS, PhD (preferred), PharmD, or MD; at least 5 years of relevant drug development experience, with significant hematology or malignant hematology trial exposure, including immuno-oncology. Deep knowledge of FDA and international regulatory standards, clinical development planning, and medical monitoring. Preferred: experience supporting NDA/BLA submissions, leading global trials, and working with innovative modalities like cell therapy. High-Value: hematology/oncology, immuno-oncology, cell therapy, early to late development stages, global regulatory engagement, and cross-functional leadership. Work setup: In-person at Gaithersburg, MD with flexibility; involved in global clinical development initiatives.