Senior Manager, Medical Studies

Servier; Boston (MA); Hybrid; USD 166.000 - 189.000; Vollzeit

Zusammenfassung

Servier is seeking a Senior Manager, Medical Studies in Boston to lead Investigator Sponsored Studies and Collaborative Research Studies in Hematology/Oncology. You will oversee governance from proposal to results, coordinating with external sponsors and cross-functional teams to meet milestones and ensure compliance.

The role requires a Bachelor’s degree in a scientific or healthcare field, 6+ years in pharma, and strong FMV/budget management skills.

Qualifikationen

• Bachelor’s degree in a scientific or healthcare field.
• 6+ years of pharmaceutical industry experience.
• Experience managing investigator-sponsored research programs, esp. hematology/oncology/rare disease.
• Knowledge of regulatory requirements (ICH/GCP, CFRs) and FMV analysis.
• Ability to manage budgets and contracts, and work with cross-functional teams.
• Proficiency with research lifecycle platforms (iEnvision, CyberGrants, IdeaPoint, SteepRock).

Aufgaben

• Lead end-to-end governance of externally sponsored studies.
• Oversee intake and decision to support new medical studies.
• Serve as primary operational contact for sponsors and internal teams.
• Conduct portfolio reviews and mitigate study risks.
• Drive contract negotiations and liaise with legal and counterpartners.
• Manage study budgets, FMV analysis, and milestone development.
• Facilitate clinical document reviews and SOP alignment.
• Support supply logistics and patient access for studies.
• Maintain eTMF readiness and internal research systems.
• Track study metrics and report portfolio status to leadership.

Kenntnisse

Excellent communication

Autonomous work

Cross-functional collaboration

Regulatory/compliance knowledge

Ausbildung

Bachelor's degree in science or healthcare

Tools

iEnvision

CyberGrants

IdeaPoint

SteepRock

Jobbeschreibung

Type of Contract: Full-time Employment / Unlimited

Senior Manager, Medical Studies

About Servier

Servier Pharmaceuticals is an independent, commercial-stage biopharmaceutical company built to think differently about what long-term impact can look like in healthcare. Launched in 2018 and backed by the strength and stability of the Servier Group, our foundation-governed model gives us the freedom to invest for the future, move with purpose, and stay focused on where patients need us most.

In less than a decade, we have grown from a small U.S. presence into a rapidly expanding, multi-billion-dollar organization with an award-winning culture, six commercial products, and a portfolio strengthened through bold strategic investments and innovation. Our teams are helping advance important new treatment options for patients facing serious diseases with high unmet need, particularly in rare oncology and neurology.

Our ambition is clear: to build a leading U.S. biopharmaceutical company known for scientific excellence, operational strength, and deep commitment to patients. Just as important is how we build it. We are creating a culture that values entrepreneurship, collaboration, accountability, and the belief that individuals at every level can shape the future of the company.

For people who want more than a job — who want the opportunity to build, lead, grow, and make a measurable impact — Servier offers the chance to be part of a company with purpose, momentum, and the ability to help define what comes next for patients and for our industry.

Role Summary

The Senior Manager, Medical Studies, Hematology/Oncology will lead the portfolio and execution of externally sponsored research programs (Investigator Sponsored Studies [ISS] and Collaborative Research Studies [CRS] programs) within the US Medical and Patient Affairs department for Servier’s Hematology/Oncology therapeutic area. Reporting to the Director of Medical Studies, Grants & Sponsorships, 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 Senior Manager will oversee end-to-end governance and 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
• Lead governance activities for the intake and decision to support new medical studies
• Serve as the primary operational contact for external sponsor teams and internal cross-functional stakeholders
• Conduct annual and routine portfolio reviews to ensure that studies are progressing in accordance with agreed upon milestones and supporting mitigation plans accordingly
• 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 escape 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 function 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
• 6+ years of experience in the pharmaceutical industry
• Experience in managing investigator sponsored research programs, preferably within hematology, oncology, or rare disease therapeutic areas required
• Proven expertise in research contracting, study budget management, and Fair Market Value (FMV) analysis
• Strong 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

Candidate Profile

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $166,000 - $189,000. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs.Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements). For more information on our benefits, please visit this link .