Clinical Research & Development Lead

Aixial Group is currently hiring a Clinical Research & Development Lead 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).

Job

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

Profile

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

Benefits

Why Join Us?

Make a positive impact and be at the forefront of project:

You will be part of groundbreaking advancement in clinical research that has positive impacts on millions of people’s lives globally.

Career Development:

People are our biggest asset. We are committed to empower our team continually and build a positive and supportive environment that fosters growth, flexibility, and teamwork. At Aixial Group, you will be coached and mentored throughout your journey to help you advance your professional and personal growth.

Our commitment to Diversity, Equality, and Inclusion:

We aim to create a workforce which promotes dignity and respect, where individual differences are recognized and valued, and where each employee can give their best.

Gender equality is at the core of the development strategy of Aixial Group.

Aixial Group continues to grow, and to recruit in the clinical trial professions. Join us, and discover our website to follow the news of our offers: https://www.aixialgroup.com/join-us/

For more information: https://www.linkedin.com/company/aixialgroup/about/

Company profile

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!

We are one of the world’s leaders in CRO (Contract Research Organisation) with the commitment, expertise, and flexibility needed to deliver efficient clinical trials.
We work with global pharmaceutical, biotech, cosmetic, medical device, and many other companies around the globe, providing them with innovative and scalable solutions.
We are operating in 10 countries across 3 continents, bringing together over 1000 talented professionals dedicated to make a positive impact in the life sciences industry.
We have been part of ALTEN Group since 2014 and are continuously exploring new opportunities to expand our activity worldwide.