Pozice:

Medical Director

Oddělení: Clinical Development, Medical
Specializace: Oncology
Přímý nadřízený: Chief Medical Officer
Místo práce: Prague, Czech Republic
Pracovní úvazek: Full time employment

Hlavní činnosti a zodpovědnosti:

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

General Objectives:

  • Medical lead for an indication or group of indications for a compound in development with main focus on oncology/hematology/(autoimmune diseases).
  • Establishing and execution of the Clinical Development Plan (CDP) for the compound within the selected indication(s).
  • Efficient and safe development of the compound in indication(s) assigned, including competent medical monitoring of individual clinical trials.
  • Medical representation of the company to the outside world in relation to the assigned compound and indication(s).
  • Line management and guidance of junior staff, e.g., Associate Medical Directors (if applicable).

 Major Tasks:

  • Contribute in designing a clinical study strategy for each product candidate to demonstrate the efficacy and safety of the product candidate 
  • Contribute as a member of clinical team to ensure effective x-functional communication and collaboration within Clinical organization and with other functions (e.g. manufacturing, science)
  • Provide leadership in clinical project/program management of clinical trials
  • Provide medical leadership and clinical best practice for the SOTIO´s full therapeutic range, moving compounds through the clinical development process
  • 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 pre-clinical 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.

Kompetence, dovednosti a kvalifikace:

Education:

  • MD with oncology or hematology specialization (one can also consider other MD specialization, but then longer industry experience in oncology/hematology is a pre-requisite).

Professional Experience:

  • 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 Skills (language, IT):

  • 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.

Napište nám (recruitment@sotio.com)

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