Medical Director
About Servier Pharmaceuticals:
We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description.
SUMMARY OF ROLE:
The Medical Director will be responsible for Servier's oncology clinical trials in cholangiocarcinoma. The Medical Director will play a lead role in the study design, protocol development, execution, and supervision of clinical programs. The individual will be responsible for ensuring that all clinical studies operate to the highest ethical and safety standards and in compliance with Company, GCP, and regulatory requirements.
The Medical Director will play a key role in contributing to the strategic research and development objectives of the Company. The individual will serve as a liaison between Servier and clinical investigators, and establish and maintain relationships with opinion leaders, trial physicians, and key regulatory officials.
Specific Responsibilities:
Medical Monitor
- Oversee the development and conduct of clinical research within the cancer metabolism space. Provide medical monitoring oversight for clinical studies in accordance with GCP
- Participate in key review of data for critical clinical and/or safety endpoints
- Support drafting of key regulatory documents
- Participate as a study team member
KOL engagement, Investigatory Led studies, and publication support
- Liaise with Medical Affairs and Patient Advocacy to provide relevant medical/clinical support for publication efforts, IITs, and engagement with key external stakeholders
Clinical Development Strategy and Execution
- Provide medical and strategic leadership for all clinical related initiatives including regulatory interactions for approval submissions globally; working closely with cross-functional representatives from the program management function
- Liaise with the translational and pre-clinical colleagues to understand important biomarker led efforts to advance our scientific understanding of the space and incorporate important elements into the future or existing clinical studies
- Support the clinical scientist function through mentorship and guidance on particular medical/clinical concepts and disease area expertise
Other duties as required or directed by the Manager or Functional Management
Skills and Education:
- M.D. or D.O. (or equivalent degree) with completion of residency or fellowship training required with a preference for specialization in Medical Oncology
- ≥2 years of clinical development or medical affairs experience in industry or ≥3 years of experience with oncology clinical research in an academic/community setting
- Demonstrated ability to lead clinical research efforts and teams within the Oncology space
- Excellent public speaking, writing, and communication skills are required. The ability to teach and mentor is also critical and work in a cross-functional collaborative way
Other Relevant Information:
- There is an opportunity for remote work
- 15% anticipated travel