Medical Director Clinical-stage biotech Any EU

vor 11 Stunden

Any EU Budapest Germany Carbyne Vollzeit 120.000 € - 180.000 € pro Jahr
Carbyne has partnered with a European publicly listed, clinical-stage biotech company with exciting immuno-oncology pipeline to search & select a Medical Director.

The role can work remotely and be home-based anywhere in Europe with limited amount of travelling in the future / join their Berlin office. The selected candidate will be responsible for the sponsor oversight of ongoing clinical studies from medical and safety aspects, for the sponsor PV part and furthermore contributes to the scientific, clinical and commercial development of company's product candidates by providing medical and scientific input as needed.

Responsibilities:
  • Serve as medical and safety monitor (sponsor part only) for ongoing clinical trials; e.g. review SAEs/CIOMS, review coding and perform medical reviews, review protocol deviations
  • Provide regular safety and medical status updates to DCD and CMO
  • Characterize, establish and update the benefit-risk profile of assigned product candidates
  • Responsible for internal PV process and propose and implement process improvements in terms of e.g. pharmacovigilance, risk assessment. 
  • Contribute to or be responsible for core documents within the clinical development e.g. DSUR, IB and others as assigned.
  • Review of, contribute to or be responsible for study core and study specific documents
  • Manage and liaise with investigators, key opinion leaders and study groups in the light of ongoing clinical trials
  • Contribute to evaluation of clinical trial data and its presentation at internal and external forums
  • Present key clinical findings to internal and external constituents
Requirements:
  • M.D. degree
  • Minimum 5 years of experience in a clinical research environment with exposure to the drug development process and participation in the design and conduct of clinical trials
  • Strong interpersonal and negotiation skills
  • Excellent project management skills
  • Excellent technical/medical writing skills (English)
  • Experience in international clinical trials
  • High standards of integrity
  • High energy level and strong self-motivation
  • Must have working knowledge of international (FDA, EMA) regulations, GCP, PhRMA principles and guidelines, and similar compliance requirements
  • Knowledge of immunology highly preferred
  • Knowledge of oncology/immuno-oncology or other serious diseases is a plus
Should you be interested please feel free to submit your CV.

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