Clinical Scientist

• Work with the Medical Director to develop Medical Management, Medical Data Review, and Eligibility Review Plans
• Engage outside experts, consultants, and advisors to coordinate medical/scientific input for medical plans
• Perform regular and ad-hoc medical review of data listings and data visualization
• Analyze data to identify risks and data patterns/trends and document medical reviews
• Identify and resolve medical data review issues
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, scientific review of study-level data, protocol deviation review, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface between internal teams, customers, and vendors for medical data review and eligibility review
• Collaborate with study team members to identify risks related to data integrity and subject safety
• Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Adhere to data privacy guidelines, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical/Medical Scientist – Oncology – GI

• Work with the Medical Director to develop medical plans
• Engage outside experts, consultants, and advisors to obtain medical/scientific input
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data, identify risks and trends, and document medical reviews
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, study-level scientific data reviews, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Identify and escalate data integrity, subject safety, deliverable, and scope concerns
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical/Medical Scientist – Oncology, Hematology

• Support late-stage oncology clinical development
• Collaborate with the Clinical Scientist Program Lead on ongoing clinical trial program activities
• Collaborate on functional area activities during program implementation
• Support clinical study start-up, execution, and closeout
• Contribute to data analysis and reporting
• Support regulatory filings
• Develop study concept sheets and protocols
• Participate in protocol review discussions
• Prepare protocols, amendments, study manual sections, Investigator meeting notebooks, and other documents
• Contribute to CRFs, Data Management Manuals, and Data Analysis Plans
• Address scientific and procedural questions from Investigators
• Contribute to data listings, summary tables, study results, manuscripts, and scientific presentations
• Assist with regulatory documents
• Anticipate clinical study obstacles and implement solutions with guidance
• Coordinate teams and provide direction when requested
• Provide clinical monitoring for clinical studies or study components
• Summarize published scientific information for new study development
• Adhere to regulatory requirements, Good Clinical Practice, and Gilead SOPs
• Create inclusion, develop talent, and empower teams as a people leader

Senior Clinical Development Scientist

• Support late-stage oncology clinical development
• Collaborate with the Clinical Scientist Program Lead on ongoing clinical trial program activities
• Collaborate on functional area activities during program implementation
• Support clinical study start-up, execution, and closeout
• Contribute to data analysis and reporting
• Support regulatory filings
• Develop study concept sheets and protocols
• Participate in protocol review discussions
• Prepare protocols, amendments, study manual sections, Investigator meeting notebooks, and related documents
• Contribute to CRFs, Data Management Manuals, and Data Analysis Plans
• Address scientific and procedural questions from Investigators
• Contribute to data listings, summary tables, study results, manuscripts, and scientific presentations
• Assist with regulatory documents
• Anticipate obstacles and implement solutions with guidance
• Coordinate teams and provide direction when requested
• Provide clinical monitoring for clinical studies or study components
• Summarize published scientific information for new study development
• Adhere to regulatory requirements, Good Clinical Practice standards, and Gilead SOPs
• Create inclusion, develop talent, and empower teams as a people leader

• Work with the Medical Director to develop medical plans, including Medical Management, Medical Data Review, and Eligibility Review Plans
• Engage outside experts, consultants, and advisors to obtain medical/scientific input for medical plans
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data to identify risks, patterns, and trends; document medical reviews
• Identify and resolve medical data review issues
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, scientific review of study-level data, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors for medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as the primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with study teams to identify risks related to data integrity and subject safety
• Escalate project deliverable risks and out-of-scope tasks to project leads
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Adhere to data privacy guidelines, ICH, GCPs, enterprise policies, standard operating procedures, work instructions, project plans, and customer procedures
• Manage a limited number of direct reports and participate in or conduct interviews

Clinical/Medical Scientist – Oncology – Breast

• Develop medical plans with the Medical Director, including Medical Management, Medical Data Review, and Eligibility Review Plans
• Coordinate acquisition of medical/scientific input from outside experts, consultants, and advisors
• Perform regular and ad-hoc medical review of data listings and visualizations
• Analyze data to identify risks and patterns/trends and document medical reviews
• Identify and resolve medical data review issues
• Author medical data queries, review responses, and approve query closure with the Medical Director
• Assist with patient profile reviews, scientific review of study-level data, protocol deviation reviews, and Medical Review Summary reports
• Partner with Medical Directors on medical data review and safety review meetings, including slide preparation
• Manage project scope, objectives, deliverable quality, milestones, and timelines
• Serve as primary interface among internal teams, customers, and vendors for medical data and eligibility review
• Collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management teams to identify data integrity and subject safety risks
• Escalate study concerns, at-risk deliverables, and out-of-scope tasks to project leads
• Attend and present at Trusted Process meetings and participate in internal and external audits
• Maintain understanding of protocol designs, disease terminology, and pathology
• Follow data privacy guidelines, ICH, GCPs, company policies, SOPs, work instructions, and project plans

Clinical Scientist jobs in United States

Clinical/Medical Scientist – Oncology – GI

Clinical/Medical Scientist – Oncology, Hematology

Senior Clinical Development Scientist

Senior Clinical Development Scientist

Clinical/Medical Scientist – Oncology – Breast

Clinical Medical Scientist – Medical Monitoring, Infectious Disease