Manager Clinical Operations - CO1


Full-time

London, England, United Kingdom

Clinical Operations

The Company:

Orchard Therapeutics is a leading global, fully integrated, commercial-stage biotech dedicated to transforming the lives of patients with rare diseases through innovative gene therapies.


Partnering with world-leading research institutions in gene therapy, Orchard’s portfolio of autologous ex vivo gene therapy programs has demonstrated sustained clinical benefit in over 150 patients across five disease areas. These programs include Strimvelis®, the first autologous ex vivo gene therapy approved by the EMA in 2016, 3 programs in advanced registrational studies in MLD (metachromatic leukodystrophy), WAS (Wiskott Aldrich syndrome) and ADA-SCID (adenosine deaminase severe combined immunodeficiency), 2 other clinical programs in X-CGD (X-linked chronic granulomatous disease) and beta-thalassemia, as well as an extensive preclinical pipeline

Orchard is a publicly traded company (NASDAQ: ORTX) with offices in the UK and the US, including London, San Francisco and Boston.

The Role:

Reporting to the Director of Clinical Operations, the Clinical Operations Manager will be accountable for managing the clinical operation activities for 2 to 3 clinical studies. This person will be key in driving the clinical studies day to day activities, ensuring on time delivery of main clinical milestones, as well as respect of GCP.

Responsibilities

  • Lead, manage and co-ordinate the conduct of assigned clinical trials from study start-up to close out in accordance with ICH-GCPOversees the quality of the clinical operations for the studies he/she is in charge of
  • Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
    • Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
    • Manages data management and statisticians ensuring data base maintenance, interim and final database locks.
    • Manages clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
  • Planning, management and reporting of clinical studies through oversight of cross-functional study activities, identification and resolution of issues, and communication of study timelines/deliverables
  • Ensuring implementation and conduct of studies in accordance with ICH-GCP guidelines
    • Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
    • Manages CRFs creation, implementation, collaborating closely with data management for the study activities
    • Ensures accurate maintenance and archiving of study records
    • OverseesTMF
  • Management of study budget and timelines
  • Management of vendors, including a CRO, to the required standards

Requirements

  • Experience & knowledge of clinical project management
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Understanding of regulatory environment, GCP/ICH
  • Experience working in an academic environment is a plus, as well as experience in orphan disease field

Education & skills

  • BsC in life sciences
  • Msc/PhD in life sciences is a plus
  • Excellent organisational and communication skills;
  • ‘Can-do’ attitude and willingness to be flexible

Benefits

The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plan. Orchard Therapeutics offer a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time.

Orchard Therapeutics is an equal opportunity employer.

For further information on this role do not hesitate to email HR@orchard-tx.com

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.