Manager, Medical Studies

Role Summary

The Manager, Medical Studies, Oncology and Neurology will lead the operational execution of externally sponsored research programs (Investigator Sponsored Studies [ISS] and Collaborative Research Studies [CRS] programs) within the US Medical and Patient Affairs department. Reporting to the Associate Director of Medical Study Operations, this individual will serve as the primary internal and external point of contact for external sponsors, investigators and cross-functional teams to ensure research milestones are met. The Manager will oversee end-to-end management of the research lifecycle from initial proposal evaluation to results delivery and completion.

Primary Responsibilities

• Lead the operational delivery of a portfolio of externally sponsored research studies, ensuring all study milestones and deliverables are met according to defined milestones and Servier governance requirements
• Serve as the primary operational contact for external sponsor teams and internal cross-functional stakeholders
• Drive contract negotiation as the business owner, supporting legal and other departments understand the needs of the business, and liaising with counterparties to translate issues into action
• Manage study-related financial activities, including Fair Market Value (FMV) analysis, budget negotiation, and milestone development
• Facilitate internal review of clinical documents, including protocols and amendments, ensuring alignment with SOPs
• Support supply logistics to ensure uninterrupted drug access for study patients
• Maintain inspection readiness by overseeing any internal modified electronic Trial Master Files (eTMF) and upkeep of internal research systems (iEnvision platform)
• Proactively identify and escalate program risks related to budget, research timelines, and resourcing
• Facilitate tracking of study metrics and progress, providing regular updates to the enterprise on portfolio status
• May support other functional needs within the medical studies team at the discretion of management, such as providing cross-coverage or flex-support during transition periods

Education and Required Skills

• Bachelor’s degree (minimum) in a scientific or healthcare discipline
• 3-5+ years of experience in the pharmaceutical industry or in absence of experience in the pharmaceutical industry 3-5+ years of experience coordinating clinical research studies is required
• Experience in managing investigator sponsored research programs, preferably within hematology, oncology, or rare disease therapeutic areas is preferred
• Expertise in research contracting, study budget management, and Fair Market Value (FMV) analysis
• Knowledge of US (required) and global (preferred) regulatory and compliance requirements including ICH/GCP, GxPs, and relevant Code of Federal Regulations (CFRs)
• Demonstrated ability to work within cross-functional teams and external stakeholder management
• Proficiency in research lifecycle management platforms (eg, iEnvision, CyberGrants, IdeaPoint, SteepRock, etc.)
• Excellent communication skills and ability to work autonomously in a dynamic, fast-paced environment

Travel and Location

• Estimated travel required: 20-25%
• Remote or Hybrid