Our client is a young Swiss biotech company with operational activities in France, active in the field of oncology, focusing on differentiated immunotherapeutic approaches. The company, led by an experienced international team, acquires drug candidates from innovative technology platforms, through in-licensing, and capital investments.
The company is currently involved in the development of a first-in-class bispecific antibody for immunotherapy that is entering the clinic phase and has recently invested in a pre-clinical allogenic natural killer (NK) cell technology, which will enter into the clinic by the ed of this year.
Reporting to the Director of Clinical Research, the Senior Clinical Trial Manager will be responsible for the operational management of clinical trials (France and international), from the protocol concept to the clinical study report.
He/She will be responsible for:
- Supervising the clinical trials implementation, in accordance with the regulations, in coordination with the CROs, and monitoring the performance
- Evaluating the resources required for the conduct of the study, managing the CRO, coordinating vendors (biometrics, centralized lab, PV…) and overseeing the supply chains of IMP and study materials
- Maintaining a good communication with investigators
- Examining and assembling the company Trial Master File (TMF)
- Controlling the budget and deadlines
- Contributing to clinical study design and regulatory dossiers
This position is located in Paris and will require regular traveling.
You have a scientific background and at least 5 years of similar experience in managing local and international clinical trials in oncology. Your experience includes knowledge of GCP, ICH guidelines and FDA regulations. Experience in managing early phase clinical studies and biological medicines trials is a plus.
You have an excellent ability to express yourself in English, both orally and in writing.
You like to work independently in a versatile role while being a real team player. Analytical, dynamic, with a taste for innovation and “solution provider”, you wish to put your expertise at the service of a promising biotech project.
If you decide to invest your energy and enthusiasm in this fast-growing entrepreneurial adventure, please apply to the following address: firstname.lastname@example.org under the reference D5645.
GenSearch is an international retained Executive Search and HR services consultancy dedicated to the Life Sciences. Our focus covers the Medical Device, Diagnostics, Pharmaceutical and Biotechnology industries. We thrive when working with companies who are in different stages of their business life-cycle from start-up companies to large multinational healthcare companies. We work closely with all our clients to add value and performance to their business. Our goal is to also help executives build a successful career in line with their aspirations and the market reality using our extensive sector knowledge.