Medical Director - Germany

Germany  ‐ Vor Ort
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Beschreibung

An exciting opportunity has opened for a medium size pharmaceutical development company for a medical director to support projects related to clinical development.

The opportunity is offered on a permanent basis and requires full time presence in the office.

Responsibilities:
  • Responsible for conceiving/writing clinical part of clinical development plan for a compound.
  • Responsible for writing protocols, participation in the conception of CRFs (paper or electronic).
  • Participation in writing Study reports as well as critical review of the study reports including quality check.
  • Participation and experience in writing/reviewing clinical part of investigator brochure specifically, the risk benefit section, information to the investigators and reference safety information.
  • Participation and experience in writing/reviewing summary documents and answering questions to the authorities.
  • Clinical studies: Responsible for Medical monitoring, medical input, online follow up of patient data, AEs and SAEs follow up, Narratives, participation in the preparation of statistical analysis plan and tables, figures and listings.
  • Investigators meeting presentations, monitors training and regular contacts with investigators, co-ordinating investigator and the key experts.
  • Over all supervision of the study conduct and close working relationship with the Clinical Trial Manager.


Skills and Qualifications
  • MD degree
  • proven experience in running clinical trials specifically Phase 2 and Phase 3 trials in the pharmaceutical industry or with international CROs.
  • Experience in running anti-infective clinical trials is beneficial
  • Previous experience in working as a physician in a hospital setting or as an investigator for a clinical trial would be beneficial.
  • Ability and experience in working as a team; in-house, with CROs, experts and opinion leaders.
  • Leadership, organization, interpersonal communication and presentation skills.
  • Results oriented, capable of setting priorities and managing high work load at times.
  • Small biotech mentality and flexibility to accept and perform the tasks of his/her direct reporting workers and colleagues across projects in case of need.
  • Fluent in business English; Writing and speaking in German would be beneficial.


Michael Bailey International is acting as an Employment Agency in relation to this vacancy.
Start
08/2019
Dauer
permanent
Von
Michael Bailey Associates
Eingestellt
16.07.2019
Projekt-ID:
1797600
Vertragsart
Festanstellung
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