Medical Director

Job location: Cracow
Ref no.: SEL/075

 

Your main task on the position will be providing medical or disease area expertise to clinical projects or trials within defined therapeutic areas for the timely preparation and execution of the clinical development program.

 

Key responsibilities are:

  • Contribute scientific and strategic input to the development and execution of the clinical development plan (CDP)
  • Preparation of clinical trial protocol summaries and protocols, reports and publications
  • Provide clinical development expertise to support other departments and line functions
  • Build relationships among the clinical/scientific community and with other external experts• Contribute medical /scientific expertise to clinical strategy and program documents (investigator brochure, IND annual report, Health/Competent Authority briefing books and submissions)
  • Participate as clinical representative in Project Teams
  • Contribute medical expertise to the execution of clinical trials (including selection of investigators/study sites)
  • Review clinical trial reports and summaries
  • Maintain oversight of product safety, and safety monitoring in clinical trials
  • Review and approval of study documents throughout the clinical trial course: feasibility questionnaires, pre-study/initiation/monitoring/close-out visit reports, statistical analysis plans, AE reconciliation reports, etc.
  • Write and review abstracts/manuscripts, etc. for presentation/publication at internal/external meetings
  • Prepare training materials for internal and external use as required

 

Your background should include:

  • Medical/scientific and state-of-the-art medical knowledge of assigned area
  • Familiar with all aspects of the clinical development process
  • Knowledge in clinical trial design, intermediate statistics and pharmacokinetics
  • Proven ability to interpret efficacy and safety data relating to assigned area
  • Medical-Scientific writing skills
  • Knowledge of GCP and world-wide regulatory requirements relating to assigned area
  • Master Degree with at least 5-8 years of experience in clinical medicine, previous industry clinical experience or experience in drug development as an investigator
  • Analytic and leadership skills
  • Very good English skills

 

As standard You will receive benefit package, which consists of:

  • Work in a team of highly-qualified and experienced professionals
  • Opportunity for a rapid career development
  • Participation in challenging and ambitious projects
  • Package of benefits: private medical healthcare, Multisport Card, lunch subsidies, days with fruits, language classes refund• Possibility to take part in sports activities
  • Access to attractive infrastructure: fitness and spa zone in the building
  • Work in a dynamic Company with high perspective of growth and operating in innovative business sector

 

 

If you are interested please send your CV to career@selvita.com with subject line Medical Director

 

We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of existing recruitment process”.

If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Selvita S.A. for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Selvita Group”.