We bring breakthrough pioneering therapies to patient with life threatening diseases
Celyad is a biopharmaceutical clinical-stage company, specialized in the development and engineering of CAR-T therapies. Our ambition is to develop a unique platform to offer new treatment options to cancer patients, addressing multiple targets, optimizing the signaling domain, and weaponizing the T-Cell.
Celyad unites passionate people who keep on pushing the boundaries of innovation, leveraging unique scientific know-how from Research & Development to Phase III clinical trials, as well as a strong expertise in cell manufacturing and logistics.
Based in Europe and in the U.S., Celyad offers a stimulating working environment built around teams of highly motivated experts. Our Company surrounds itself with the best industrial and academic partners to explore the full potential of our technological platform.
At Celyad, we know that every second counts for the patients and their families, and that is what drives us in our work every single day. Ready to take up this challenge?
Celyad is looking for an enthusiastic:
Clinical Scientist (M/F)
The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the Medical Director located in Belgium.
Role & Responsibilities
- Support the Clinical Development Leader in effective implementation, conduct and oversight of global clinical trials, including day to day interactions with other central functions, study centers and external partners (CROs);
- Contribute to development of clinical development plan, briefing documents, regulatory documents, protocols, ICF, CRF, end of study reports, etc. and analysis of the data in support to the Clinical Development team;
- Contribute to ensuring the highest clinical research standards and adherence to all internal and external policies, rules and regulations;
- Serve as primary point of contact for clinical studies inquiries from site staff, CRO’s and site monitors regarding the study protocols, modifications to informed consent and patient-specific questions;
- Closely collaborate with Data Manager for case report form (CRF) design, instructions for unique CRF’s and data quality plans;
- Participate in tracking and analysis of any potential safety events within a given trial and across trials for assigned programs;
- Together with Biostatisticians and Medical Directors, review appropriate analysis and reporting documents (e.g. clinical study reports, analysis plans, and so forth);
- Collect and communicate medical/scientific information within the disease and product area (internal data, medical/scientific publications, congresses, etc.) in collaboration with the Clinical Development and Market Access Teams;
- Contribute to the preparation and follow-up of IDMC, steering committees, and advisory boards in support to the CRDL;
- Participation of internal meetings (study team and project team meetings, etc.) and external meetings (investigators meeting, advisory boards, monitors meeting, etc.) becoming a Clinical R&D representative if required;
- Participate to the development of long term strategic plans for the assigned programs;
- Participate in Health Authority interactions and present at external forums when appropriate;
- In collaboration with Medical Director, create and review clinical slides for internal and external meetings (e.g. Investigator Meetings, CTA & CRA trainings, Advisory Boards, Scientific Meetings, and so forth);
- Give advice on study analytical strategy and data strategy;
- Provide input for regulatory filings and other appropriate documentations;
- Conduct clinical data reviews.
Qualifications & Experience
- MD or PhD in life sciences or scientific field
- Proficient in computer skills (Microsoft Office)
- Minimum 3 years of pharma/biotech industry experience, preferably 5, in clinical research
- Fluency in English and French or Dutch, any other language is an asset
- GCP training
Skills & Competencies
- Ability to write and check content/quality of scientific documents
- Outstanding communication skills with a broad range of stakeholders (KOL’s, PI’s, Scientific Community, and so forth)
- Drive and hands on attitude
- Good organizational skills
- Team spirit
- Strong business presentation skills
- Pro-active and assertive
- Effective decision making and sound judgement
- Result driven
- International travel might be required (<30%)
For more information about this position or about the Company, please contact us by email at firstname.lastname@example.org