Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 130 highly qualified employees.
In order to advance modern medicine and significantly improve the management of serious diseases, we have developed and successfully established a powerful new class of potent, specific and versatile small protein therapies, called DARPin® therapeutics.
The continuous development of a broad portfolio of therapeutic product candidates in oncology and ophthalmology based on the company’s proprietary DARPin® platform allowed a successful listing of the company on the SIX Swiss Exchange (ticker: MOLN). Next to our own pipeline of drug candidates we have entered into collaborations with leading international pharmaceutical companies, including Allergan, Roche, Janssen Pharmaceuticals and Amgen.
The highly dedicated, multi-disciplined team at MP is committed to developing breakthrough medicines for serious diseases.
MOLECULAR PARTNERS - Clinical Trial Manager M/F (80-100%)
To take on responsibility for operational planning and management of clinical trials, we are looking for a highly motivated Clinical Trial Manager.
The challenging and diverse position will include the following tasks and responsibilities:
- Head the clinical study team
- Develop clinical outsourcing specifications to facilitate bid templates and selection of clinical research vendors (e.g. CRO, laboratories)
- Management of interfaces and definition of operational specifications for MPAG vs clinical research vendors for conduct of clinical trials
- Ensure optimal administrative/operational monitoring of clinical studies (includes participation in feasibility assessments, site selection, site visits/co-monitoring, management of Investigator/study site interactions, etc.)
- Day to day interaction with the CRO, third party vendors and study sites to ensure sponsor’s oversight responsibilities
- Management of trial budget
- Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality/GCP standards
- Development/preparation of relevant sections of clinical study protocols and related documents in collaboration with CROs; development of study tools, guidelines, and training materials; management of clinical study material; and implementation of issue resolution plans
- Contribute to the development of clinical sections of regulatory documents, such as IBs/briefing books/safety updates/CTA/BLA submission documents, responses to Health Authority (HA) questions, etc. as needed
- Ensure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs
- Ensure clinical documents (or copies when applicable) are filed in appropriate designations (e.g. regulatory repository) and ensure that an up-to-date audit trial is maintained
- Assist with drug/lab supply management for the clinical trials
- Update regularly all trial information databases and tracking systems in order to manage accuracy of information
- Support development of standard processes, planning and resource management tools and performance metrics to achieve excellence in clinical program management
Frau Barbara Weber
+41 44 755 57 65