Director Clinical Operations - P19-14


London, England, United Kingdom

Clinical Operations

Please note that this post will close on July 23rd 2019

  • Lead and co-ordinate the conduct of the clinical operations at program level, providing leadership on execution, from implementation of study design to close out at a global level in accordance with ICH-GCP.

  • Oversee the quality and scientific integrity of clinical operations for studies at a global level


  • Collaborates with cross functional stakeholders to ensure timely and on budget execution of clinical trial deliverables
    • Coordinates medical writing activities with Clinical Sciences/external vendors. Coordinates medical writing and all the activities necessary for delivering of documentation: publishing, QC, etc
    • Coordinates at program leveldata management and statistics activities ensuring data base maintenance, database lock, etc
    • Oversees clinical sites and academics institutions, ensures adherence for keeping clinical records, source documents, data entry, manages clinical trial logistics, applications (IRB, local agencies)
    • Primary point of escalation for all significant issues encountered on the performance of the studies

  • 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 study(ies) in the program accordance with ICH-GCP guidelines
    • Ensures team development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
    • Oversees CRFs creation, implementation, ensuring data management is properly for the study activities
    • Oversees accurate maintenance and archiving of study records

  • Management of study budget, timelines and resources within your programs, FTEs as well as out of pocket expenses
  • Escalation point for management of vendors to the required standards
  • Interact with clinical investigators and key opinion leaders

  • Travel as required to support the execution of clinical studies as required.

Requirements

Experience Required

  • • Demonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key opinion leaders, and investigators
    • Demonstrated ability to work well in teams in a cross functional manner
    • Ability to think critically, and demonstrated troubleshooting and problem solving skills
  • Excellent experience & knowledge of clinical project management
  • Experience in oversight of external vendors (e.g. CROs, central labs, etc.)
  • Experience in managing budgets
  • Understanding of regulatory environment, GCP/ICH
  • Experience working in an academic environment is a plus, as well as experience in orphan disease field
  • BsC in life sciences
  • Msc/PhD in life sciences is a plus
  • Excellent leadership, organisational and communication skills;

Education & skills

Comfortable in a fast-paced biotech environment,able to adjust workload based upon changing priorities and self driven

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.

Benefits

Orchard Therapeutics offers a competitive Salary with a complete benefits package that includes:

  • Medical Insurance for the employee and dependents
  • Dental Insurance for the employee and dependents
  • Optical Insurance for the employee and dependents
  • Life insurance
  • Private pension
  • Long Term illness cover