Role SummaryServier 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.
Key deliverables include:
- 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
Primary ResponsibilitiesClinical 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 authors 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 leads KOL engagements
- Provide publication support
- Perform additional duties as required or directed by the Manager or Functional Management
Education and Required Skills- 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 workstreams 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 investigator brochures, 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.
Job DescriptionCandidate ProfileSalary RangeThe 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. 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.
