Manager, Medical Studies

SERVIER MONDE • Boston, KY

12d • $145,000 - $166,000

About The Position

The Manager, Medical Studies, Oncology and Neurology leads the operational execution of externally sponsored research programs, including Investigator Sponsored Studies (ISS) and Collaborative Research Studies (CRS), within the US Medical and Patient Affairs department. Reporting to the Associate Director of Medical Study Operations, the Manager is the primary internal and external point of contact for sponsors, investigators, and cross-functional teams, overseeing the research lifecycle from proposal evaluation through results delivery and study completion. The role is remote or hybrid and involves an estimated 20–25% travel.

Servier Pharmaceuticals is an independent, commercial-stage biopharmaceutical company launched in 2018 and backed by the Servier Group. The company describes itself as a rapidly expanding organization with six commercial products and a focus on serious diseases with high unmet need, particularly rare oncology and neurology. Its stated ambition is to build a leading U.S. biopharmaceutical company through scientific excellence, operational strength, and commitment to patients, supported by a culture of entrepreneurship, collaboration, and accountability.

Requirements

• Bachelor’s degree at minimum in a scientific or healthcare discipline.
• 3–5+ years of pharmaceutical industry experience, or, in the absence of pharmaceutical industry experience, 3–5+ years coordinating clinical research studies.
• Expertise in research contracting, study budget management, and Fair Market Value (FMV) analysis.
• Knowledge of U.S. regulatory and compliance requirements, including ICH/GCP, GxPs, and relevant Code of Federal Regulations (CFRs).
• Demonstrated ability to work within cross-functional teams and manage external stakeholders.
• Proficiency with research lifecycle management platforms, such as iEnvision, CyberGrants, IdeaPoint, or SteepRock.
• Excellent communication skills and ability to work autonomously in a dynamic, fast-paced environment.

Nice To Haves

• Experience managing investigator-sponsored research programs, preferably in hematology, oncology, or rare disease therapeutic areas.
• Knowledge of global regulatory and compliance requirements, including ICH/GCP, GxPs, and relevant CFRs.

Responsibilities

• Lead operational delivery of a portfolio of externally sponsored research studies, ensuring milestones and deliverables meet defined timelines and Servier governance requirements.
• Serve as the primary operational contact for external sponsor teams and internal cross-functional stakeholders.
• Drive contract negotiations as the business owner, helping legal and other departments understand business needs and translating issues with counterparties 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, to ensure alignment with SOPs.
• Support supply logistics to ensure uninterrupted drug access for study patients.
• Maintain inspection readiness by overseeing internal modified electronic Trial Master Files (eTMF) and upkeep of internal research systems, including the iEnvision platform.
• Proactively identify and escalate program risks related to budget, research timelines, and resourcing.
• Facilitate tracking of study metrics and progress and provide regular enterprise updates on portfolio status.
• Support other medical studies team needs at management’s discretion, such as cross-coverage or flex-support during transition periods.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Flexible time off, including unlimited sick time and flex time with no accrued time off
• 401(k)
• Life insurance
• Disability insurance
• Recognition programs
• Short-Term and Long-Term incentive programs

What This Job Offers

• Job Type: Full-time
• Career Level: Manager