Director, Distribution & Logistics - GDP2


Full-time

Boston, Massachusetts, United States

Commercial

Location: Field Based – United States
Reporting to: Vice President – Global Distribution & Patient Access Support Services

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, Boston and the Bay Area, California.


Job summary

The Director of Distribution will be responsible for implementing and managing a compliant, high-performing logistics programs and orchestrating such to allow gene therapy for individual patients. This person will be held accountable for having keen Knowledge of hospital operations, management of logistics providers, 2°-8° and liquid nitrogen shipper vendors and chain of custody programs. In-depth knowledge of the flow of money, relevant customs duty, good practices (GxP), throughout the entire distribution stream are essential. Must be experienced in leading teams and poses the ability to drive the team to achieve department and company goals.

Key Elements and Responsibilities

  • Assist in designing, implementing and managing an orchestrated logistical program that encompasses all aspects of the Cellular/Gene treatment for individual patients including;
  • The harvest, packaging and collection of each patient’s bone marrow or peripheral blood (cells) at the designated hospitals/site of care (SOC).
  • Safe storage and delivery of cells to the designated manufacturing facility which can be outside the country of origin.
  • The on-time delivery of the gene therapy drug product (DP) in a cryopreserved state, from the manufacturing facility to the designated (SOC) for the scheduled patient administration.
  • Coordinate the scheduled patient administration date and the manufacturing date with the SOC and Orchard Supply Chain Team.
  • Work with vendors and internal cross functional partners to develop and implement resource tools such as CRM and chain of custody programs.
  • Close interaction with clinical team to ensure near team potential patient requirements are understood as clinical programs transition to commercially approved products.
  • Partner with internal and external stakeholders to understand the Cellular Supply Chain and to assess the potential impact to patient administrations.
  • Lead the coordination of the SOC qualification process and manage timings for new site implementations.
  • Partner with Patient Support leadership to establish relationships with all treatment sites and create Orchard specific patient navigation programs and ensure treatment site compliance with the program.
  • Interact and partner with Medical Information, Clinical Thought Liaisons and other field personnel as appropriate.
  • Pro-actively assess continuous improvement of the overall processes.
  • Provide out of hours coverage as required.
  • Develop and comply with applicable Standard Operating Procedures (SOPs).
  • Develop and manage the budget for the department.
  • Keep detailed records, generate reports, develop and deliver presentations to senior management for all aspects related to areas of responsibility.
  • Determine and manage logistics KPIs.
  • Develop processes and procedures from scratch as needed.
  • Train and evaluate others.

Requirements

Required knowledge

  • Previous leadership experience, preferably within the rare disease space, in patient specific operations, distribution and logistics.
  • Exceptional knowledge of time sensitive, sometimes lifesaving distribution programs.
  • Experience with launch teams and preparations for rare and orphan drug product launches
  • Experience with managing outsourced vendors.
  • In depth knowledge of specialty product distribution including Good Practices (GxP)
  • 5 to 10 years of experience as mentioned above and in the pharmaceutical/biotech industry.
  • Travel is required, sometimes with little notice

Education

Advanced degree or relevant work experience

Orchard Therapeutics is an Equal Opportunity, Affirmative Action employer. Minorities, women, veterans, and individuals with disabilities are encouraged to apply.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify

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.