International Medical Director

Category: Clinical Development

Location:Søborg, Capital Region of Denmark, DK

• Play an important role as a responsible trial physician in several of our paediatric trials within rare blood disorders, which involves designing the clinical trials, providing medical oversight in the trial conduct phase, monitoring the safety of participants, interpreting and documenting trial results, and supporting submissions to health authorities

• Work with Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC (Chemistry, Manufacturing, and Controls), Biostatistics and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities
• Serve as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to resolve clinical development problems

• Ensure compliance with SOPs (Standard Operating Procedures), ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use), GCP (Good Clinical Practice) and other national and international regulatory requirements
• Have a high degree of independence, where decisions taken have a high degree of business impact and you can use your expertise to mentor and share knowledge with less-experienced colleagues

• A Medical Doctor degree, preferably complemented by a Ph D with at least 3-4 years of clinical drug development experience from the pharmaceutical or biotech industry

• Experience in paediatrics, but also in haematology/haemoglobinopathies is an advantage
• Capability of providing mentorship and training to junior colleagues combined with excellent collaboration and stakeholder management skills

• Excellent written and oral communication skills in English
• Integrity, highest ethical standards and a sense of personal accountability, as well as ability to quickly adapt and provide innovative solutions to challenges as they present themselves