Clinical Research

• Lead development, evaluation, planning and execution of clinical studies for oncology programs
• Ensure integrity and interpretation of study data of a clinical development program
• Lead in a matrix environment as part of a cross-functional team and contribute to early/late phase candidate development projects
• Report to the Associate Director, Clinical Sciences and collaborate closely with Medical Director(s)
• Contribute to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings
• Member of the Clinical Study Team and Global Clinical SubTeam
• Develop/maintain understanding of therapeutic disease areas, drug candidates and mechanism of action
• Support initiation and execution of clinical research and development studies; author or review protocol sections, amendments and related trial documents
• Assist with or author medical monitoring plans, SAPs, informed consents, clinical components of Clinical Study Reports and regulatory documents; may perform quality review
• Maintain compliance with FDA, EMEA, ICH and GCP guidelines and applicable SOPs
• Perform clinical/medical data review including safety monitoring and patient safety activities
• Identify critical risks and mitigations and review clinical data review plans and medical monitoring plans

Senior Manager, Clinical Scientist – Oncology

Clinical Research Intern

Head and Neck Clinical Research Coordinator

Biostatistician

Senior Clinical Scientist, GIS

Clinical Research Coordinator I – Non RN