Clinical Development Scientist - LE-CS2
London, England, United Kingdom
The Clinical Development Scientist role at Orchard Therapeutics 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, size of the team and flexibility of the Orchard Therapeutics structure. 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 project planning, including tracking timelines, activities, critical path and milestone activities, and budget
- Write clinical study documents, including protocols, regulatory documents, clinical study reports and journal publications
- Plan, review and support the deliverables of clinical studies
- Help project leaders and medical directors with the day to day activities in clinical development
- Help project leaders and medical directors in clinical study data review and analysis
- Support the project team with up to date 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
- Manage vendors (CROs and consultants)
- Any other duties as required by the VP Clinical Development or the company
- 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)