Director, Medical Study Management Operations and External Funding

About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. 

Role Summary

The Director of Study Management Operations and External Funding at Servier Pharmaceuticals will oversee all aspects of investigator-sponsored studies (ISS), collaborative research studies (CRS), Continuing Medical Education (CME) grants, Medical Sponsorships, and Congress Operations for major conferences such as ASCO, SNO, and ASH. Reporting to the Senior Director of Medical Operations, this role includes strategic planning, people management, and ensuring timely deliverables and budget oversight. The Director will lead process improvements, enhance governance, and foster cross-functional collaborations. Additionally, the Director will align external funding initiatives with the Medical Strategy, working closely with the Associate Director, Medical Study Operations, and the Sr. Manager of Congress Ops, CME, and Sponsorships

Primary Responsibilities

• Responsible to ensure ISS and CRS programs are led compliantly through processes, FMV, safety, regulatory, and training guidance
• Drive Program planning, allocation and management of program budgets, timelines and program results
• Assess risk strategy/mitigation planning,and ensuring annual review of Areas of Interest.
• Supervise all budgeting aspects including annual planning, initial projections for upcoming activities/programs, reforecasts, actuals, and accrual information.
• Coordinate with appropriate cross-functional colleagues in drug/material planning including timing of drug, expiry events and potential impact, and ensuring compliance for shipments
• Adheres to and ensures team adherence to all applicable SOPs, working guidance, workflows, required reporting, maintaining support of programs.
• Create/update relevant SOPs, working practices, forms and tracking documents as needed, ensuring audit readiness
• Provide monthly dashboards, quarterly medical reviews, and annual required reports

Education and Required Skills

• Bachelor Degree required in a scientific, healthcare, or engineering discipline; Advanced Degree (preferred) in relevant scientific field
• 8+ years professional experience with minimum of 5 years relevant Medical Affairs experience in pharmaceutical or biotech industry.
• Must have experience working in Oncology and Oncology therapeutic products
• Well-grounded knowledge of investigator-initiated study principles, processes and systems. Experience in both US investigator sponsored studies and collaborative research desired
• Knowledge of medical affairs external funding including CME grants and medical sponsorships
• Knowledgeable in pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation
• Skilled in project management 
• Demonstrated management and leadership skills
• Self-organized, self-directing, and initiative-taking
• Strong critical thinking and analytical skills
• Effective communication skills, including oral, written and presentation skills
• Excellent interpersonal skills with the ability to work collaboratively in teams and with autonomy
• Willing to work in a fast-paced environment with high attention to details and accuracy.
• Excellent prioritization and organizational skills
• Works effectively on cross-functional teams and matrix management.

Travel and Location

• Estimate the amount of travel required: 20%
• Boston based preferred but remote permitted

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.