About Celyad

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 Development Director (M/F)

The successful candidate will be based in Mont-Saint-Guibert (Belgium) and will report into the VP Head Global Clinical Development and Medical Affairs located in Belgium.

Role & Responsibilities

  • Provide leadership and medical expertise to Company’s clinical development programs including pivotal studies
  • Build effective relationships with site investigators and KOL’s
  • Write clinical study protocols in collaboration with the CMO
  • Review and provide medical/safety input of periodic benefit risk evaluation report, periodic safety update report, clinical expert statement, and so forth
  • Effectively communicate with clinical operations/development staff, project management, IT, clinical QA, legal and other internal and external (CRO) staff and support as appropriate
  • Support regulatory submissions including NDA
  • Lead the development of clinical strategies for the innovative new drug candidates and drive successful implementation of such strategies
  • Responsible for drafting clinical development plans, writing clinical trial protocol synopses and study protocols; leading discussions and revisions of study design with internal stakeholders and external experts/consultants
  • Key physician contact for sites and investigators during site start-up and study execution:
    • act as a liaison between the company and clinical investigators,
    • develop credible relationships with opinion leaders
    • participate in the medical review,
    • conduct safety/pharmacovigilance reviews,
    • interpretation and reporting of the results of the research, including submissions to health authorities
  • Contribute to INDs, IMPDs and other regulatory submissions, and play an important role in the required regulatory interactions with the FDA, EMEA and other regulatory authorities
  • Evaluate scientific information and new ideas to assist in identifying new research and development opportunities
  • Perform all job responsibilities in accordance with standards of Good Clinical Practice (GCP)
  • Support regulatory strategies and interactions with global regulatory authorities
  • Reviews all protocols prior to acceptance at the site for feasibility
  • Reviews Investigator's Brochure prior to performing any study related activities
  • Delegate study responsibilities as appropriate to trained study staff (clinical operations, clinical development and translational science)

Qualifications & Experience

  • MD or PhD in life sciences or scientific field
  • Immuno-oncology experience and/or certification is a must
  • Extensive experience in early-stage development (focus on human clinical trial design and translational medicine)
  • Thorough understanding of medical coding (MEDRA)
  • Thorough knowledge of basic and clinical cancer research and its application to cancer drug development
  • Proficient in computer skills (Microsoft Office)
  • Pharma/biotech industry experience in clinical research is a must
  • Fluent in English, any other language is an asset
  • GCP training

Skills & Competencies

  • 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%)

Download the PDF file linked to the position

Celyad respects and recognizes your privacy. The information that you provide to us will be used solely for the purposes of processing your application. This information may be shared with Celyad’s affiliates and partners. For more information about how Celyad uses your data, see the terms of use.

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