Medical Director, Neuro-Oncology
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.
About the role
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
Responsibilities
Clinical Development Strategy and Execution
- 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
Medical Monitor
- 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 author key sections of the clinical trial protocols
Team Collaboration
- 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 lead KOL engagements
- Provide publication support
- Perform additional duties as required or directed by the Manager or Functional Management
Qualifications
- 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
Skills
- Excellent public speaking, writing, and communication skills; ability to teach and mentor
- Strong collaborative mindset to stimulate and support sustained cross-functional engagement and high performance
- Problem-solving mindset with the ability to be creative and execute a vision that drives innovation
- Ability to organize and prioritize workstreams and guide teams through challenges
- Excellent operational execution and ability to meet critical timelines
- 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 leading cohort safety evaluation meetings in early phase studies, co-authoring investigator brochures, and providing clinical expertise on PV-related documents
Travel and Location
Anticipated travel 10-20% of the time. The position is open for candidates hybrid in Boston, MA, or remote within the United States; East Coast is highly preferred.
Pay
The salary range for this role is $250,000 - $316,000. 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. Employees in this position are also eligible for Short-Term and Long-Term incentive programs.
Benefits
- Medical, dental, and vision insurance
- Flexible time off (unlimited sick time and flex time, no accrual)
- 401(k)
- Life and disability insurance
- Recognition programs