Clinical/Medical Scientist – Oncology, Hematology

Job Description:

• 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

Requirements:

• Clinical/medical science experience in oncology and hematology
• Ability to develop medical plans, including Medical Management Plan, Medical Data Review Plan, and Eligibility Review Plan
• Experience performing medical review of data listings and data visualizations
• Ability to analyze data to identify risks and data patterns/trends
• Ability to author medical data queries and review query responses
• Knowledge of patient profile review, study-level scientific data review, and protocol deviation review
• Knowledge of ongoing protocol designs and disease-related terminology and pathology
• Understanding of data integrity and subject safety risks
• Adherence to data privacy guidelines, ICH, GCPs, enterprise policies, SOPs, work instructions, and project plans
• Equivalent experience, skills, and/or education will be considered

Benefits:

• Career development and progression
• Supportive and engaged line management
• Technical and therapeutic area training
• Peer recognition and total rewards program
• Inclusive culture
• Company car or car allowance
• Medical, dental, and vision health benefits
• Company match 401(k)
• Employee Stock Purchase Plan eligibility
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO)
• Sick time