Location:                 London, UK

Reporting to:          Director, Clinical Sciences

Job Summary

Orchard Therapeutics is a global biotechnology gene therapy company dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative cell and gene therapies. Orchard has its global headquarters in London and its U.S. headquarters in Boston and is a wholly owned subsidiary of Kyowa Kirin, a Japan-based Global Specialty Pharmaceutical Company.

The Clinical Scientist role at Orchard Therapeutics is a key support for the Clinical Sciences leads for the programs and their assigned projects. The successful candidate will have the opportunity to take part and contribute to project planning, clinical research documentation and key activities of clinical development. This is a unique opportunity to join an agile and progressive team who are working to develop innovative therapies. 

The position will suit a dynamic and motivated individual with prior experience in clinical science, eager to learn and continue developing their skills in the field, and looking for an opportunity to join a collaborative team, where they can apply their curious, problem-solving mindset in a fast-paced, high-impact environment.

Key Elements and Responsibilities

Some of the main activities of the role are:

• Contribute to the authoring and take responsibility for completing updates of clinical study documents (including protocols, regulatory documents, clinical study reports and publications)
• Plan, review and support the deliverables related to clinical studies (such as; annual update of study documents, generation of briefing books for regulatory interactions)
• Help the broader Clinical Science team with:
  • Day-to-day activities in clinical development (e.g. reviewing and maintaining study documents; monitoring trial progress and adherence to study protocol(s), troubleshoot issues, and contribute to problem-solving efforts; preparation of regulatory documents; collaborating with cross-functional teams to ensure smooth execution of clinical studies)
  • Clinical study data review and analysis
  • Preparation of expert subject documents and presentations
  • Up-to-date literature and literature research relevant to the projects
• Help with preparation of meetings, team meetings, ad-hoc meetings, and produce meeting minutes
• Ensure maintenance of the specific program folders
• Provide up to date project planning, including tracking timelines, activities, critical path, milestone activities, and budget
• Support the team in monitoring the quality conduct of the clinical studies
• Support the team to plan and prepare for/present at meetings with investigators and experts in the field and prepare presentations for scientific conferences
• Support the team with management of vendors (CROs and consultants)

Requirements

Required Knowledge

• Experience in protocol writing, clinical trial activities, and clinical study report writing, ideally gained through roles such as Clinical Researcher, Clinical Research Associate (CRA), Clinical Trial Assistant (CTA), or Clinical Scientist.
• Understanding of the regulatory environment, GCP/ICH, which will enable the individual to ensure clinical trials are conducted in compliance with global regulatory standards, maintain high-quality data integrity, and support the preparation of regulatory submissions and documents for ethics committees and health authorities.
• Ideally, previous experience in the rare disease field and/or gene therapy/paediatrics/neurology/metabolic backgrounds, gained through direct involvement in clinical trials, clinical research coordination, or related roles in specialized therapeutic areas.

Skills and Abilities

• Accountable and responsible individual
• Collaborative working style: Able to partner effectively with their colleagues across the organization to seek critical information
• Excellent organizational skills
• ‘Can-do’ attitude and willingness to be flexible
• Able to manage complex data
• Curious and problem-solving mindset
• Able to work in a dynamic environment
• 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)

Education

• Life Sciences degree: BSc / Master’s Degree / PhD

Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.