Clinical Operations Manager

vor 4 Wochen

Vienna, Österreich Valneva Vollzeit

We are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine solutions.

We have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel vaccines, including the world’s first and only chikungunya vaccine, as well as certain third-party vaccines.

Revenues from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, as well as vaccine candidates against the Zika virus and other global public health threats.

Responsibilities
  • Responsible for all aspects of one or more phase 1-4 clinical studies from protocol through clinical study report finalization for regulatory submission
  • Ensures compliance with ICH-GCP and FDA/EMA regulations, other regulations, and SOPs, as applicable
  • Ensures all operational study deliverables are met according to timelines, budget, operational procedures, and quality standards
  • Manages CROs and other external partners and ensures adherence to scope of work within timelines and budget
  • Interacts with other departments and relevant functional areas
  • May be required to travel to supervise and coordinate clinical studies

Requirements

  • Academic education, Master or PhD degree in Life Science
  • Minimum of 3 years of clinical management experience
  • Profound knowledge of ICH-GCP, data protection laws, clinical trial directive and other regulations and guidelines relevant for the conduct of clinical trials
  • Ideally experience in the field of vaccine development
  • Supervisory/managerial experience in clinical development including supervision of CROs and/ or CRAs is a must
  • Excellent communication, presentation, interpersonal, independent problem solving, financial management and leadership skills
  • Organized and independent work style with strong systematic approach to prioritization but still detail oriented
  • Excellent command of English (spoken and written) and excellent computer skills

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, etc.

Due to legal reasons we are obliged to disclose the minimum salary for this position, which is € 60.000,00 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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