Scientist, Preclinical Development, Early Stage Programs - CR2


Full-time

London, England, United Kingdom

Discovery Preclinical

Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.

The role job offers the successful candidate the opportunity for a broad multi-disciplinary role. involving the next paradigm of transformative gene therapy treatments and provides the opportunity to help define the regulatory study requirements for these treatments. The role will be focused on bringing commercial company expertise and support to a significant and wide-ranging academic collaboration from pre-clinical development to early clinical work.

The successful candidate will be a key stakeholder; influencing the development of Orchard Therapeutics and our academic collaborator’s treatment strategies for the foreseeable future, as well as acting as the preclinical scientific lead for a portion of these programs. As such the ideal candidate will take ownership and lead several of these programmes.

This role is ideal for an experienced professional who is looking to work in a small team with high-level academic collaborators at the top of their field, whilst also working and engaging with the large and highly experienced commercial, manufacturing and pre-clinical teams at Orchard. The role may suit someone with pre-clinical experience gained either in an academic setting, a CRO or clinical-stage cell therapy company.

Requirements

Responsibilities

The candidate should support the Preclinical development of the Orchard therapeutic programs and assist the academic partners in fulfilling their scientific and regulatory objectives, facilitating the development of the therapies through initial proof of concept and into early stage clinical studies and beyond. This will include regulatory, project licence and study design recommendations based on the individuals experience. The advisory role will also include data QC and interpretation review for the preclinical programs along with scientific and regulatory advice.

The role will include regular visits to the academic partners related to the associated programmes to ensure active discussions are held and ensure the academic partners are achieving the regulatory requirements as part of their studies. The role will also include collation of data, for presentation within Orchard (primarily to the Senior Director of Preclinical Development and the Chief Scientific Officer).

As part of the role the successful candidate will also take responsibility for the budgeting requirements for the academic led studies. This will include budget preparation and consultation.

The candidate will also hold a liaison role between Contact Research Organisations (CRO) and academic partners and, on occasion, where the Sponsor status is held by Orchard Therapeutics, (IE in instances where a study is placed within a CRO) the candidate will act as the Study Monitor, providing overview and management of pivotal regulatory studies. This will include Test facility Monitoring visits for key study events and the facilitating Quality Assurance Audits at the test facility to ensure compliance.

The candidate will also assist in the preparation of regulatory documents within Orchard Therapeutics to help support the Clinical Development group, acting as an advisor and scientific lead for the preclinical/non-clinical sections of regulatory documentation, and will on occasion liaise with regulatory authorities as the need arises, this will include the data prepared by the academic groups.

Job requirements

  • The candidate must have a broad scientific background with a minimum of MSc level education in a relevant subject.
  • The candidate must have experience within a regulatory compliant preclinical group within industry (10+ years).
  • The candidate must have a good understanding of EMEA and FDA regulatory requirements.
  • The candidate will ideally currently hold the title of Study Director, Programme Manager or an equivalent title within a large pharmaceutical or CRO.
  • The candidate must be experienced in regulatory study design, data interpretation and report preparation.
  • The candidate must have had prior exposure to regulatory document preparation (ECTD, CTD, BLA, IND preparation), however training can be provided as required.
  • Prior experience with cell and/or gene therapy (particularly with hematopoietic stem cell transplantation or CNS disease models and biology) is highly desirable
  • Experience working with academic groups (either directly or in collaboration) is desirable

Education and skills

  • Educated to a minimum MSc Level within a Scientific discipline.
  • Strong communication skills and computer literacy
  • Presentation skills
  • Attention to detail
  • Ability to confront constructively, to resolve to the maximum benefit of all parties involved.

RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics.  Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.