Clinical Scientist

About the company

JCR Pharmaceuticals Co., Ltd. is a fully integrated specialty Biopharmaceutical company focusing on the treatment of rare diseases including growth hormone deficiency, anemia, graft-versus-host disease, Fabry Disease and Mucopolysaccharidosis Type II. Founded in 1975 and headquartered in Ashiya, Hyogo prefecture, JCR has around 900 employees, with biomanufacturing sites and research centers in Kobe (Japan), and overseas subsidiaries in San Diego (USA), Leiden (Netherlands), and Sao Paulo (Brazil).

What We Do

For many years JCR has been developing a technology (J-Brain Cargo®) to transport biotherapeutics across the blood-brain-barrier to address neurologic symptoms in children affected with rare genetic diseases (lysosomal storage diseases). In 2021, JCR was the first company to successfully submit the first molecule based on this technology (IZCARGO®) to regulatory approval for the treatment of MPS II (Hunter Syndrome) in Japan. The molecule is currently in global phase 3 clinical development to bring this innovation to patients across the world. Helping these individuals fulfill some of their hopes and dreams through the medicines we develop gives us a deep sense of purpose.

Applying this technology, JCR has built an industry-leading development portfolio of 16 potentially game-changing programs in lysosomal storage diseases, all of them addressing a unique unmet medical need. While three programs are currently in clinical trials, several others are expected to enter the clinic in the next years. JCR Pharmaceuticals has an oursourced study delivery model.

Job description

 The Clinical Scientist role at JCR is a key support for the Clinical Development leaders and their assigned projects. The successful candidate would have the opportunity to take part and contribute to project planning, clinical research documentation and key activities of clinical development. This is a unique role to the industry because of the innovative therapy area and size of the team. In addition to this the successful candidate will be able to have input in all stages of clinical development process, from preclinical to registration.

Some of the main activities of the role are:

• Provide up to date clinical project planning, including tracking timelines, activities, critical path and milestone activities, and budget
• Write / input clinical study documents, including protocols, regulatory documents, clinical study reports and journal publications
• Plan, review and support the deliverables of clinical studies
• Work with Project Leaders and Medical Monitors with the day to day activities in clinical development
• Work with Project Leaders and Medical Directors in clinical study data review and analysis
• Support the Project Team with uptodate literature and literature research relevant to the projects
• Support Project Leaders and Medical Directors in preparation of expert subject documents and presentations
• Help with preparation of meetings, project team meetings, add-hoc meetings, and produce meeting minutes.
• Support clinical operation team in the quality conduct of the clinical studies
• Help to plan and prepare/present investigators meetings
• Help to prepare presentations for scientific conferences
• Help to prepare clinical documents for regulatory submissions
• Manage vendors (CROs and consultants)
• Any other duties as required by the Head of Clinical Development

REQUISITIONS

• Life science degree
• Previous experience in the rare disease field
• Experience in protocol writing, clinical trial management, and report writing
• Must possess excellent written and verbal communication skills in order to successfully liaise with and influence internal/external stakeholders, and communicate critical aspects of ongoing project activities
• Proficiency with computer and standard office software programs is required.
• Must be fluent in English both verbal and written (technical)

The position is based in Europe. We do have an office in Leiden, but remote working is also possible.

Contact email: alice@hrjcreurope.onmicrosoft.com