Executive Director Clinical Development

vor 3 Wochen

Frankfurt am Main, Hessen, Deutschland Pharmiweb Vollzeit
Pharmiweb Seeks Executive Director Clinical Development - Oncology

We are looking for a seasoned Executive Director Clinical Development - Oncology to drive the clinical development of our oncology projects. As a key member of our team, you will be responsible for representing Medicine at International Multidisciplinary Evidence Teams and taking clinical development responsibility for assigned projects.

Key Responsibilities:
  • Provide medical oversight to clinical trial programs, including protocol development, conduct, analysis, and reporting.
  • Oversee medical project budgets and support contacts with external experts, advisory boards, and regulatory authorities.
  • Lead medical leadership in regulatory meetings and contribute to submission strategy, regulatory dossiers, and safety issues.
  • Identify the need for studies and provide input to Medical Affairs strategy documents.
  • Review and approve publications within your project.
Accountabilities:
  • Author Investigator's Brochures, Asset Evidence Plans, Core Clinical Trial Protocols, and Pediatric Development Plans with cross-functional project teams.
  • Mentor a team of Clinical Program Leads.
  • Provide input to Project Analysis & Data Management Plans, Company Core Data Sheet, and Annual Safety Report.
  • Lead medical leadership in regulatory meetings and support submission strategy, regulatory dossiers, and safety issues.
  • Maintain an external focus to ensure a good understanding of relevant customer groups.
Requirements:
  • MD (specialist in Oncology or equivalent) with sound clinical oncology experience and (ideally) some years of experience in the pharmaceutical industry.
  • Successful track record in planning, conduct, and publication of Basic Science and/or Clinical Research.
  • Sound medical and scientific leadership to drive high-priority projects in collaboration with global matrix teams.
  • Previous contacts with regulatory authorities, international societies, and other relevant international stakeholders.
  • Good communication and presentation skills.
  • Excellent cross-functional collaboration skills and ability to work in virtual teams.
  • Full command of English language.
Additional Requirements:
  • MD (specialist in Oncology or equivalent) with sound clinical oncology experience and multiple years of experience in the pharmaceutical industry.
  • Profound clinical development experience as well as multiple years of experience in Pharmaceutical Industry in an international role.

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