Clinical Research & Development Lead M/F

at  Aixial

You are a highly skilled professional with passion for the world of Life Sciences and Clinical Research? You want to thrive in a dynamic and collaborative international environment where your expertise directly impacts people lives?
Come and join Aixial Group to contribute to shaping the future of clinical research!
Aixial Group is currently hiring a Clinical Research & Development Lead M/F for a position based in Brussels.
As a Clinical Research & Development Lead, you will participate to Phase I-IV Clinical Development activities within a program or group of related programs in order to ensure the high quality and on-time delivery of all clinical data that will allow world-wide registration in compliance with the clinical development plan, good clinical practices (GCP), and standard operating procedures (SOP).

Your tasks will be to (non-exhaustive list):

• Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate
• Define the outline and content of the protocol,
• Analyse and interpret the results as a subject matter expert.
• Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
• Assure that results meet the highest standards of quality and ethical conduct.
• Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
• Assume accountability for the medical/legal and human safety aspects of the clinical study.
• Liaise with Vigilance 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.
• Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
• Actively participate in preparing the clinical portion of the regulatory files and the registration process
• Contribute to development of clinical section of regulatory files, including labeling.

Professional experiences, qualifications and skills required :

• PhD specializing in the field of pediatrics, obstetrics and gynecology, infectious diseases, clinical epidemiology, or pharma-co-epidemiology.
• At least 3 years of work experience in clinical research
• Knowledge and understanding of vaccines, clinical research, and biomedical research regulation, including ICH and GCP
• Good communication skills

Languages :

• Fluent in English (spoken and written) is mandatory
• Proficient in Dutch and/or French would be a plus

• Contribute to activities or components of a Clinical and Epidemiology Plan (CEP) as appropriate
• Define the outline and content of the protocol,
• Analyse and interpret the results as a subject matter expert.
• Supervise the study conduct, and serve as the accountable for the overall delivery of the clinical trial.
• Assure that results meet the highest standards of quality and ethical conduct.
• Complete tasks in support of these activities as necessary, such as developing internal and external briefing documents, and other such activities requiring relevant technical expertise and clinical development experience.
• Assume accountability for the medical/legal and human safety aspects of the clinical study.
• Liaise with Vigilance 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.
• Actively participate as a core member of the clinical project team and contribute to achievement of team objectives.
• Actively participate in preparing the clinical portion of the regulatory files and the registration process
• Contribute to development of clinical section of regulatory files, including labeling