Clinical Research & Development Lead M/F
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Denmark and Czech Republic.
Aixial is hiring a Clinical Research & Development Lead.
The role in a few words:
The Clinical Research and Development Lead, who will be member of the Clinical Project team, will serve as a support to Marketing/Business Development throughout product life cycle and will actively participate to Phase I-IV Clinical Development activities.
For this hybrid role, your responsibility will include but are not limited to:
- Design clinical trial protocols, and author clinical study reports and publications of high scientific, operational and ethical standards as well as ensure consistency of data within program and across projects.
- Bear primary responsibility and accountability for scientific and medical quality and timeliness of clinical trial synopses and protocols and all clinical trial documents, including the Investigator’s Brochure and the Clinical Study Report.
- Assumes accountability for the medical/legal and human safety aspects of the clinical study.• Address scientific and medical issues related to one or more clinical studies. Pay special attention to serious adverse events occurring during clinical trials and potential safety signals.
- Liaise with PV to develop Risk Management Plans (RMPs), Global Safety Data sheets, Development Safety Updated reports (DSUR), and Periodic Safety Updated Reports (PSUR) and serves on SRT (Safety Review Team), as applicable. In clinical studies, together with PV analyse safety and potential signals and escalate accordingly.
- Contribute to development of clinical section of regulatory files, including labelling
- MD or PhD with ability to independently research questions; sound scientific background required to critically evaluate all scientific aspects of vaccinology / immunology.
- Previous experience in the field of respiratory functions, obstetrics and gynecology, infectious diseases, clinical epidemiology, pharmacoepidemiology, and/or clinical vaccinology is an asset.
- Excellent level in English (spoken and written) is required