Position Medical Director
Department Clinical Development, Medical
Therapy Area Oncology
Responsible To Chief Medical Officer
Location Prague, Czech Republic
Employment Type Full Time Employment

Position Summary

Supervision of Associate Medical Director(s); when applicable.

Key Activities and Responsibilities

  • Medical monitoring of trials, with focus on medical review of study documentation and individual patient information, investigator communication, and continuous safety evaluation (in cooperation with pharmacovigilance department).
  • Author, and/or support writing, and/or reviewing of medical documents; such as clinical study protocols, investigator’s brochures, clinical study reports, clinical development plans, manuscripts for publication of research results, literature reviews, internal and external presentations, newsletters, sections of INDs/CTAs, other regulatory documents.
  • Support development of case report forms, statistical analysis plans (including study report tables and listings), and other related documents (e.g., automated query definitions) together with data management and statistics.
  • Close interaction across the whole development team (medical + operational + regulatory + safety + data management/statistics + medical affairs etc.; both locally and internationally) to support efficient and safe conduct of clinical studies.
  • Close interaction with Regulatory Affairs department including medical support in association with e.g., regulatory interactions and preparations of regulatory documents.
  • Close interaction with pre-clinical development scientists when applicable for e.g., medical support regarding selection and validation of new drug targets, medical interpretation of preclinical data, etc.
  • Support of due-diligence processes when applicable.
  • Establish and maintain close interaction with opinion leaders within the appropriate area of work (compound in selected indication(s)) to secure support for the clinical program.
  • Monitoring of competitors within the appropriate area of work (compound in selected indication(s)).
  • Contribute to the work of other divisions (manufacturing, supply chain, etc.) if needed and appropriate.
  • Oncology medical training and education of other employees when appropriate.
  • To participate at preparation of Advisory Boards and Investigator’s Meetings.

Competences, Skills and Qualification

Prefered Qualification:

  • Sufficient drug development industry experience, i.e. at least 5 years. If an adequate time has been spent on drug development in academia, e.g. university or cooperative group setting, this could compensate for a shorter experience within the drug development industry.
  • Experience from own work related to clinical study responsibility (i.e. as medical monitor of studies).
  • Adequate knowledge of ethical principles and drug laws and regulations to be able to function as medical monitor of clinical studies.
  • Experience from own work with medical review of important (preferentially pivotal) clinical studies.
  • Experience from early and late stage clinical development.
  • Experience from responsibilities related to leading/arranging investigator meetings, DMCs/ DRCs/IDMCs, advisory board meetings.
  • Experience in the basic medical bio-statistic and interpretation of clinical trial results.
  • Experience in the field of pharmacovigilance incl. national and EU legislative knowledge.
  • Ideally experience in medical marketing incl. development of marketing strategies/tactics.
  • Ideally filing experience (mainly FDA and/or EMA, or possibly other).
  • Management experience desirable.
  • International experience desirable.

Other Requirements

  • English, excellent verbal fluency and written proficiency is a must.
  • Good knowledge of MS-Office.

Personal Skills:

  • Dynamic, team- and goal-oriented, personality.
  • Very good communication and presentation skills.
  • Highest integrity regarding data assessments as well as interaction in team and company settings.
  • Preferentially shown ability to work in global setting, including also settings managing junior colleagues.
  • Good time management.
  • Willingness to travel.

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