Clinical/Medical Scientist – Oncology – GI

Job Description:

• 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

Requirements:

• Experience and deep expertise in clinical/medical science and drug development
• Basic understanding and knowledge of ongoing protocol designs
• Basic understanding of disease-related terminology and pathology
• Knowledge of medical data review and eligibility review
• Knowledge of data listings and data visualization
• Ability to analyze data to identify risks and data patterns/trends
• Knowledge of International Committee on Harmonization (ICH) guidelines and Good Clinical Practices (GCPs)
• Ability to adhere to data privacy guidelines, enterprise policies, standard operating procedures, work instructions, and project plans
• Ability to collaborate with Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Management
• Ability to participate in or conduct interviews
• 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 401k
• Eligibility to participate in Employee Stock Purchase Plan
• Eligibility to earn commissions/bonus based on company and individual performance
• Flexible paid time off (PTO)
• Sick time