Director Medical Monitoring

vor 2 Monaten

Wien, Österreich Valneva SE Vollzeit

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 both to commercialize three vaccines, including the world's first and only chikungunya vaccine, and to rapidly advance a broad range of vaccine candidates into and through the clinic, including candidates against Lyme disease, Shigella and Zika.

With operations in Austria, Canada, France, Sweden, the United Kingdom, and the U.S., we are committed to making a positive impact on global public health.

Together, we are a global Company which is open to people of all backgrounds. Our diverse and inclusive workforce makes Valneva a great place to work.

Responsibilities

This role provides specialist support to global vaccine development related medical activities including Medical Monitoring, training of internal and external teams with regards to the clinical trials/studies of the development programs.

  • Develops the Medical Monitoring and Oversight concept on program level and the implementation on trial level (Medical Monitoring Plans)
  • Steers and manages external teams of regional medical monitors
  • Supports Clinical Strategy in the development and maintenance of professional and credible relationships with key opinion leaders
  • Provides relevant medical input to essential documents on program and trial level
  • Provides training to internal and external stakeholders on medical contents (e.g. clinical trial teams at Valneva and at Vendors, clinical trial teams at investigational sites)
  • Keeps abreast of professional information through conferences and medical literature and acts as a therapeutic area subject matter expert
  • Responsible for compliance with applicable processes concerning Medical Monitoring, and specifically also for the concerned interface to and interaction with Clinical Safety
  • Ensures budgets, timelines, compliance requirements are factored into programs' medical activities
Minimum Requirements
  • Medical Doctorate (M.D.) degree and experience in Clinical Development are mandatory
  • Relevant therapeutic experience in immunology or vaccinology preferred
  • At least 3 years of experience in clinical development
  • Experience of managing cross-functional global teams on development program level
  • Ability to run Medical Monitoring / Medical Oversight of the assigned programs/trials
  • Knowledge of clinical trial methodology, regulatory requirements governing clinical trials/studies and experience in the review and interpretation of clinical trial protocols and respective translation into Medical Monitoring strategies
  • Knowhow with working on complex problems, in which analysis of situation or data requires an in-depth evaluation of various complex factors
  • Sound understanding of clinical safety requirements
  • Excellent oral and written communication skills
Company Culture and Benefits
  • Open, appreciative company culture with innovative spirit and attractive assignments
  • International surrounding with flat hierarchies
  • Good team spirit in a strong and highly motivated team
  • Wide range of benefits like flexitime, compensation days, performance-related bonus, lunch vouchers, child care center ("Kindergarten"), company events, myClubs, full access to LinkedIn Learning,

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 110.000 gross per year based on full-time employment. However our salaries are market oriented and in line with your qualifications and experience.

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