Supply Chain Manager, Distribution & Logistics-Clinical

Location
San Francisco, CA, United States
Posted
May 22, 2021
Ref
1079
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
SUPPLY CHAIN MANAGER, DISTRIBUTION AND LOGISTICS

Position Summary:

This position is an individual contributor responsible for managing distribution and logistics activities to ensure timely and continuous Investigational Medicinal Product (IMP) supply to global clinical studies for GBT development programs. This role will be the Subject Matter Expert in global import and export requirements and coordination of importation readiness for GBT study drug. In this role, the incumbent will work closely with Clinical Operations, Regulatory Affairs, Technical Operations, other members of the Clinical Supply Chain team, and logistics and transport providers to ensure continued drug supply for clinical studies to successfully meet clinical and development program goals.

Essential Duties and Responsibilities:

  • Distribution and Logistics - Set up, manage and monitor global distribution networks based on study requirements
  • Develop Finished Good kit distribution and depot strategies in partnership with Supply Chain Clinical Study Managers
  • Provide input and guidance to depots on distribution instructions. Partner with packaging and logistics team as required to maximize efficiencies in distribution activities
  • Import/Export - consolidate and manage IMP global import/export requirements internal documentation. Coordinate and manage country specific Import License applications for all clinical studies
  • Shipment coordination, shipment track & trace (monitor in process shipments and involvement to ensure proper and timely delivery of products), interface with contracted carriers and depots as required. Manage logistics issue resolution, including any requiring quality investigations
  • Reverse Logistics - coordinate, setup and oversee study drug return and destruction programs at contracted vendors/facilities
  • Management and proper storage of related GxP documentation such shipment temp data and IMP returns and destruction documents
  • Systems - knowledgeable on Interactive Response Technologies (IRT) supply strategies as well as eTMF (Electronic Trial Master Files)
  • Vendor management - effective distribution and logistics vendor oversight ensuring timelines are met. Manage external vendor relationships from a business and operations perspective. Subject Matter Expert in reviewing contracts and applicable rates
  • Manage distribution forecasts and projections, review and approve distribution invoices
  • Participate in Clinical Study Execution (SET) meetings as Supply Chain Subject Matter Expert as required
  • Procedures - develop and establish Standard Operating Procedures (SOP's) as required. Manage and/or support process improvement initiatives
  • Monitor performance of distribution and logistics providers. Prepare Key Performance Indicators (KPI)'s and management reports
  • Other tasks as assigned may include, support in management of global depot inventories supplying clinical studies and assist in the review and tracking of vendor quotes, purchase orders, and invoices


Qualifications:

  • BS/BA or MBA degree
  • Typically requires 5+ years of experience in clinical or commercial supply chain management
  • Working knowledge of cGXP's, familiar with US, EU regulations applicable to investigational drugs and drug development process
  • Working knowledge of global distribution and transport providers
  • Able to influence colleagues and partners via persuasive and effective arguments. Great communication skills - Communicates in clear and concise manner. Listen actively and ask relevant questions as needed in order to deepen understanding
  • Good organizational skills, effective project and time management skills, and able to meet tight timelines. Excellent interpersonal skills
  • Customer Service oriented, collaborative and self-starter
  • Proficient in Microsoft Outlook, Word & Excel. Excel modeling capabilities a plus
  • Good knowledge of Customs and Trade Practices
  • Experience with managing global clinical distribution networks and managing global import licensing programs
  • Experience with pharmaceutical cold chain distribution and temperature control management, as well as experience in exporting to non-traditional geographical markets
  • Vendor management experience, specifically with global Clinical Packaging and Distribution vendors
  • Clinical and/or commercial supply chain, planning or materials management, inventory management, and business process facilitation
  • Experience with supplying global randomized, blinded studies
  • Some travel may be required (< 10%)


Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity


NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.

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