Director, Distribution & Logistics - GDP1
London, England, United Kingdom
Location: Field Based – Europe
Reporting to: Vice President – Global Distribution & Patient Access Support Services
Orchard Therapeutics is a fully integrated commercial-stage biopharmaceutical company dedicated to transforming the lives of patients with serious and life-threatening rare disease through innovative gene therapies.
Orchard currently has offices in the U.K. and the U.S., including London, San Francisco and Boston
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 and manage the effort of working with treatment sites to ensure Orchard specific patient navigation programs are in place.
- Interact and partner with Medical Information and other regional personnel as appropriate.
- Lead the coordination of the SOC qualification process and manage timings for new site implementations
- 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.
- 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)
- Substantial experience, as listed above, in the pharmaceutical/biotech industry
- Travel is required. This potential employee would be required to be in the London site frequently.
- Must speak fluent English. Multiple languages preferred
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
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.