- Supporting the company’s development portfolio in all clinical research and development aspects.
- Planning, conducting, monitoring, and reporting of clinical programs as well as regulatory filing activities.
- Acting as the Medical and Scientific Expert and liaison to all internal and external development stakeholders
- Member of the Core Product Team. Representing the company and its products on conferences, meetings and at authority meetings
- Medical and Scientific support to all ongoing or planned clinical research activities and programs of all phases of development
- Providing medical support to sites, investigators and other internal and external stakeholders of clinical trials and studies from planning to reporting
- Acting as the Medical Monitor in clinical trials and studies incl. data review and data mining activities
- Support and scientific input into MAAs/ Review of CTDs
- Take ownership on the development and maintenance of SOPs and all related documents and procedures
- Provide medical input to product differentiation strategy
- Act as the clinical expert/ lead related to In-/Out-licensing
- Develop publication plans together with other key stakeholders, participate in relevant congresses
- Review and clinical assessment of competitor information
Qualifications and Experience:
- An MD qualification is a must, Board certification will be an advantage
- Experience in clinical research, either in academic or industrial setting
- Fluent written and spoken English is a must, additional command of other languages will be an advantage
- Knowledge and experience in Data mining
- Good presentation skills.
- Analytical thinking with a pragmatic problem solving approach.
- Ability to lead and guide a wider team.
- Good knowledge of SDTM and CDASH standards.
- Relevant working/residency permit or Swiss/EU-Citizenship required