Clinical Development Scientist

• Support late-stage oncology clinical development in collaboration with the Clinical Scientist Lead
• Collaborate on functional-area activities during program implementation
• Support clinical study start-up, execution, and closeout
• Develop study concept sheets and protocols
• Participate in protocol review discussions on scientific and procedural study-design aspects
• Prepare protocols, amendments, study-manual sections, Investigator meeting notebooks, and related documents
• Contribute to CRF, Data Management Manual, and Data Analysis Plan design and development
• Address scientific and procedural questions from Investigators
• Contribute to preparing and reviewing data listings, summary tables, study results, manuscripts, and scientific presentations
• Assist with regulatory-document preparation and review
• Anticipate moderately complex clinical-study obstacles and implement solutions with guidance
• Provide clinical monitoring for clinical studies or components of larger studies
• Summarize published scientific information to support new study development
• Adhere to regulatory requirements, Good Clinical Practice, and Gilead SOPs

• Bachelor's Degree and Six Years' Experience OR Master's Degree and Four Years' Experience
• PharmD or PhD in clinical research or clinical pharmacology preferred
• Relevant scientific and/or drug development experience
• Experience in Multiple Myeloma and/or CAR-T Therapy preferred
• Experience with Microsoft Office and other job-related programs
• Ability to learn quickly
• Flexibility and adaptability to change and ability to move between projects
• Proven analytical abilities through past experience and/or academic research
• Understanding of drug development phases and associated clinical trials across phases
• Knowledge of FDA and EMA regulations, ICH guidelines, and Good Clinical Practice
• Familiarity with standard clinical procedures
• Strong communication and organizational skills
• Ability to travel when needed

Demonstrates expertise in late-stage oncology clinical development, including protocol preparation, regulatory document review, and adherence to Good Clinical Practice. Proficient in managing clinical study activities and addressing scientific inquiries while ensuring compliance with FDA and EMA regulations.

• Clinical Study Management
• Protocol Development
• Regulatory Document Preparation
• Oncology Drug Development
• Data Analysis and Reporting

• Clinical Research
• Study Protocols
• Data Management
• Regulatory Compliance
• Analytical Skills