Senior Manager, Medical Studies

SERVIER MONDE•Boston, KY

8d•$166,000 - $189,000

About The Position

The Senior Manager, Medical Studies, Hematology/Oncology leads the portfolio and execution of externally sponsored research programs, including Investigator Sponsored Studies (ISS) and Collaborative Research Studies (CRS), within Servier’s US Medical and Patient Affairs department. The role oversees the full research lifecycle, from proposal evaluation through results delivery and study completion, and ensures research milestones are met in accordance with Servier governance requirements. Reporting to the Director of Medical Studies, Grants & Sponsorships, this person serves as the primary internal and external contact for sponsors, investigators, and cross-functional teams. The position involves study governance, portfolio oversight, contract and budget management, clinical document review, study supply coordination, and maintenance of inspection readiness and research systems. It also includes monitoring program risks, tracking study metrics, and reporting portfolio progress. The role is remote or hybrid and requires an estimated 20–25% travel.

Requirements

Bachelor’s degree or higher in a scientific or healthcare discipline.
At least 6 years of experience in the pharmaceutical industry.
Experience managing investigator-sponsored research programs, preferably in hematology, oncology, or rare disease.
Expertise in research contracting, study budget management, and Fair Market Value (FMV) analysis.
Strong knowledge of US regulatory and compliance requirements, including ICH/GCP, GxPs, and relevant Code of Federal Regulations (CFRs).
Ability to work with 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

Knowledge of global regulatory and compliance requirements, including ICH/GCP, GxPs, and relevant CFRs.
Experience in hematology, oncology, or rare disease therapeutic areas.

Responsibilities

Lead operational delivery of a portfolio of externally sponsored research studies, ensuring milestones and deliverables meet defined timelines and Servier governance requirements.
Lead governance activities for intake and decisions on supporting new medical studies.
Serve as the primary operational contact for external sponsor teams and internal cross-functional stakeholders.
Conduct annual and routine portfolio reviews and support mitigation plans for studies that are not progressing according to agreed milestones.
Drive contract negotiations as the business owner, helping legal and other departments understand business needs and liaising with counterparties to resolve issues.
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 maintain uninterrupted drug access for study patients.
Maintain inspection readiness by overseeing internal modified electronic Trial Master Files (eTMF) and maintaining internal research systems, including the iEnvision platform.
Identify and escalate risks related to budgets, research timelines, and resourcing.
Track study metrics and progress and provide regular enterprise updates on portfolio status.
Support other medical studies function needs as requested by management, including cross-coverage or flexible support during transitions.