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Global Medical Oversight Specialist for Vaccine Development
vor 1 Monat
We are a specialty vaccine company that develops, manufactures and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs.
We have leveraged our expertise and capabilities to commercialize three vaccines, including the world's first and only chikungunya vaccine. Our team has also rapidly advanced a broad range of vaccine candidates into and through the clinic, covering Lyme disease, Shigella and Zika.
With operations in multiple countries, we are committed to making a positive impact on global public health. Our diverse workforce is open to people from all backgrounds, making Valneva a great place to work.
Key Responsibilities- This role provides specialist support to global vaccine development related medical activities, focusing on Medical Monitoring, training internal and external teams regarding clinical trials/studies of development programs.
- The specialist will develop the Medical Monitoring and Oversight concept at the program level and implement it on trial level (Medical Monitoring Plans).
- They will steer and manage external teams of regional medical monitors.
- Supports Clinical Strategy by developing and maintaining professional and credible relationships with key opinion leaders.
- Provides relevant medical input to essential documents on program and trial level.
- Trains internal and external stakeholders on medical content, such as clinical trial teams at Valneva and vendors, investigational sites.
- Stays up-to-date with professional information through conferences and medical literature and acts as a therapeutic area subject matter expert.
- Ensures compliance with applicable processes concerning Medical Monitoring and specifically interfaces with Clinical Safety.
- A Medical Doctorate (M.D.) degree and experience in Clinical Development are mandatory.
- Relevant therapeutic experience in immunology or vaccinology is preferred.
- At least 3 years of experience in clinical development.
- Experience managing cross-functional global teams on development program level.
- Ability to run Medical Monitoring/Medical Oversight of assigned programs/trials.
- Knowledge of clinical trial methodology, regulatory requirements governing clinical trials/studies and experience reviewing/interpreting clinical trial protocols and translating into Medical Monitoring strategies.
- Ability to work with complex problems, analyzing situations/data requires in-depth evaluation of various factors.
- Solid understanding of clinical safety requirements.
- Excellent oral and written communication skills.
This is a challenging opportunity for an experienced Medical Professional to join our team in a leadership capacity, overseeing Medical Monitoring activities globally.
The successful candidate will be responsible for providing strategic guidance on Medical Monitoring and will lead cross-functional teams to deliver high-quality results.
We offer a competitive salary package of approximately €110,000 per year based on full-time employment, depending on qualifications and experience. Our salaries are market-oriented and performance-based.
