Medical Director, Neuro-Oncology; Boston

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.

Servier is seeking a Medical Director to serve as Medical Monitor for Phase 3 registration enabling studies within the Neuro Oncology portfolio. The role will support late-stage execution, patient safety, data quality, protocol implementation, investigator engagement, and regulatory interactions.

• In collaboration with the Global Clinical Lead, development of clinical plans and protocols in a matrix team environment
• Provision of medical and scientific oversight for the execution of registration-enabling studies across Neuro Oncology
• Support for the transition of selected internal assets from early development to late-stage development
• Delivery of clinical and scientific input on external innovation opportunities

• Provide medical oversight for all clinical-related activities on assigned studies including: study execution, regulatory interactions, and safety monitoring in close partnership with the clinical asset lead, regulatory affairs, safety and other key cross-functional representatives
• Develop and lead presentation for internal governance meetings to support timely and efficient decision making
• Support the clinical scientist function through mentorship and guidance on medical/clinical concepts and disease area expertise

• Serve as primary source of medical accountability and oversight for clinical trials in accordance with GCP
• Lead medical review of data for critical clinical and/or safety endpoints and medical literature to evidence-based decision-making and communication
• Responsible for site interactions in partnership with the Clinical Scientist (CS)
• Responsible for assessment of key safety-related adverse events including serious adverse events in partnership with safety physicians
• Provide key medical and clinical input into protocol development and authors key sections of the clinical trial protocols

• Work closely with cross-functional teams, including the clinical sub-team, regulatory affairs, and medical affairs, to ensure alignment and successful product development
• Partner with key opinion leaders (KOL) and leads KOL engagements
• Provide publication support
• Perform additional duties as required or directed by the Manager or Functional Management

• M.D. required with a strong preference for specialty training and board certification in Medical Oncology or neuro-oncology.
• 2 or more years in clinical trial experience, either in industry or academic setting.
• Excellent public speaking, writing, and communication skills required. Ability to teach and mentor is also critical and work in a cross-functional collaborative way.
• Strong collaborative mindset to stimulate and support sustained cross-functional engagement and high performance
• Problem solving mindset with the ability to be creative and to execute a vision that seeks to drive innovation
• Ability to organize and prioritize work streams and guide teams through challenges
• Excellent operational execution and ability to meet critical timelines
• Team player with strong matrix working capability.
• Ability to manage complex issues and coordinate multiple projects simultaneously.
• Proven track record practicing sound medical judgment as it relates to clinical acumen and risk assessment including but not limited to leading cohort safety evaluation meetings in early phase studies, co-authoring…