Clinical Research Scientist - III* (GILDJP00017222)

Responsibilities

• Apply knowledge of clinical trial design to support the development of study concepts, protocols, and related clinical research documents.
• Contribute to protocol review discussions, providing input on scientific and operational aspects of study design.
• Prepare and maintain study protocols, protocol amendments, study manuals, investigator meeting materials, and other study-related documentation.
• Assist in the development of Case Report Forms (CRFs), Data Management Plans, and Statistical Analysis Plans.
• Support responses to scientific and study-related inquiries from investigators and research sites.
• Participate in the preparation and review of clinical study deliverables, including data summaries, study reports, manuscripts, and scientific presentations.
• Assist with the preparation and review of regulatory documentation, including annual reports, safety reports, investigator brochures, and regulatory submissions.
• Support clinical development objectives by identifying potential study challenges and contributing to solutions under appropriate guidance.
• Collaborate cross-functionally with internal teams and may provide coordination or direction for assigned projects and initiatives.
• Lead or support specific components of departmental strategic initiatives and process improvement efforts.
• Conduct literature reviews and evaluate scientific publications to support study design and development within new therapeutic areas.
• Maintain strong written and verbal communication while building effective working relationships across teams to support the scientific integrity of clinical studies.
• Serve as a resource to colleagues by providing scientific insights and helping resolve moderately complex issues.

Qualifications

• PharmD with 2+ years of scientific research, clinical development, or pharmaceutical industry experience; OR
• Master's degree in a scientific discipline with 6+ years of relevant scientific research or drug development experience; OR
• Bachelor's degree or Registered Nurse (RN) qualification with 8+ years of relevant scientific research or drug development experience.
• Strong understanding of clinical research, drug development processes, and regulatory requirements.
• Ability to interpret scientific literature and apply findings to clinical study development.
• Excellent communication, organizational, problem-solving, and collaboration skills.

Benefits

• Health coverage
• Life insurance
• Disability insurance
• 401k benefits