Medical Director Oncology

Posted 3 years ago

Key responsibilities

  • Develop a clinical strategy and design a protocol for the product, taking into account current medical practice, regulatory requirements, business needs as well as the competitive environment
  • Be an integral member of the development team and work closely with Clinical Operations, Biostatisticians, Drug Safety, Regulatory Affairs, and Business functions
  • Provide functional leadership to the Clinical Scientist assigned to the program with respect to monitoring, reviewing, and interpreting patient profiles, safety and efficacy data of a study on an ongoing basis and assure the completeness and quality of the data
  • Responsible for the updating of the Clinical Development Plan with respect to study-related activities
  • Consult with internal and external experts for the generation of an innovative and optimal designed clinical program and Clinical Trial Protocol
  • Deliver and execute a clinical development plan in collaboration with study teams by ensuring: efficient execution of protocols, appropriate study medical monitoring, timely resolution of issues, and reporting of study results including communication at congresses
  • Provide guidance and support to the clinical study team with respect to identifying lead investigator(s) and high-quality investigational sites and the organization of Investigator Meetings
  • Act as a medical expert for clinical study teams, CRO’s, study sites, and others
  • Develop and consolidate a network of Key Opinion Leaders /investigators, participate in medical congresses and symposia, and take the lead in the organization of Scientific Advisory Boards.
  • Develop the scientific communication plan and supervise the development and delivery of scientific publications and scientific presentations to internal and external stakeholders
  • Provide medical expertise for interactions with Regulatory Authorities worldwide
  • Provide leadership to ensure the successful delivery of the clinical program, proactive identification and mitigation of risks, elaboration of contingency scenarios, swift handling, and resolution of issues and uncertainties, execution of the program to the highest scientific and GCP quality standards

Your profile

  • Medical Doctor with clinical experience in oncology (solid tumours)
  • Evidence of keeping up to date with the recent development in clinical practice and scientific progress
  • Successful and solid experience in pharmaceutical drug development (phase I-II) of at least 5 years, with a proven track record in having led at least one oncology development program through different stages of development
  • Open-mindedness, flexible, with a high level of scientific/medical curiosity
  • Being able to deal with uncertainty, manage risks and drive a proper decision making
  • Strategic thinking and innovative mindset, combined with project management and operational skills
  • Leadership and ability to collaborate in a team within a matrix organization, while remaining autonomous and entrepreneurial-minded
  • Ability to travel (20-30%)

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