Immune Design

Sr. Manager/Associate Director, Clinical Supply Management

US-CA-South San Francisco
2 months ago(10/27/2017 10:42 AM)
ID
2017-1040
# of Openings
1

Overview

The Manager/Associate Director, Clinical Supply Management is responsible for implementing and managing all aspects of the clinical supply chain in support of Immune Designs’ and its partners’ clinical needs. This position will act as the interface between the Supply Chain, Clinical Operations, Medical Affairs, Manufacturing, and Quality to ensure timely availability of finished drug products, combination products, comparator products, and matching placebos for use in global clinical studies. This role will oversee shipment and drug return logistical activities as well as over-labeling by interacting with internal and external customers and suppliers to accomplish project objectives. This role will represent Supply Chain in all relevant Clinical and CMC meetings and work with Clinical Operations to help develop investigational medicinal product (IMP) forecasts, distribution, and return drug plans. The Clinical Supply Chain Manager also monitors clinical site inventory levels and provides feedback to the Clinical Operations team regarding expiry and re-supply. This role may also assist in the set up and management of an Interactive Response Technology (IRT) system for drug supply management. The candidate for this position will be expected to have Global Clinical Supply Management experience, working closely with internal and external parties to develop budgets and timelines as well as maintaining supplier and partner relationships.

 

Responsibilities

The Manager/Associate Director, Clinical Supply Management is responsible for implementing and managing all aspects of the clinical supply chain in support of Immune Designs’ and its partners’ clinical needs. This position will act as the interface between the Supply Chain, Clinical Operations, Medical Affairs, Manufacturing, and Quality to ensure timely availability of finished drug products, combination products, comparator products, and matching placebos for use in global clinical studies. This role will oversee shipment and drug return logistical activities as well as over-labeling by interacting with internal and external customers and suppliers to accomplish project objectives. This role will represent Supply Chain in all relevant Clinical and CMC meetings and work with Clinical Operations to help develop investigational medicinal product (IMP) forecasts, distribution, and return drug plans. The Clinical Supply Chain Manager also monitors clinical site inventory levels and provides feedback to the Clinical Operations team regarding expiry and re-supply. This role may also assist in the set up and management of an Interactive Response Technology (IRT) system for drug supply management. The candidate for this position will be expected to have Global Clinical Supply Management experience, working closely with internal and external parties to develop budgets and timelines as well as maintaining supplier and partner relationships.

 

    • Ensure continuous reassessment of project needs
    • Interface with members of Clinical Operations to provide and obtain information to ensure on-time delivery of products
  • Identify, specify and manage IRT systems (includes but not limited to):
    • Provide details, such as inventory levels, unit buffers, shipment quantities, and distribution strategies, for the support of building the specification documents
    • Day-to-day support of the IRT, including shipment accuracy and tracking, shipment strategy changes, and shipment errors
    • Ensure communication between the IRT & distribution CMO
    • Release of initial and re-supply materials and inventory monitoring 
  • Responsible for daily IMP fulfillment needs across all clinical trials, including ISTs
  • Collaborate with Manufacturing and Quality to regularly monitor drug re-test/expiry, and the appropriate inventory re-supply strategy
    • Provide timely updates to Clinical Trial Managers
  • Collaborate with Manufacturing on sourcing of placebo as needed
  • Develop the clinical supplies packaging designs and labeling artwork to coincide with the protocol(s), regulatory requirements, blinding/randomization concerns and ease of handling by the sites / patients
  • Administer vendor management process including
    • Vendor selection process
    • Request for Proposals (RFP), and Statements of Work (SOWs) with vendors
    • Creating purchase requests and collaborating with Finance to monitor purchase orders, process invoices, and regularly review budget and spending
    • Collaborate with vendors to generate inventory reports, and review regularly budget and spending
  • Develop and support the governance process with vendors
  • Write and/or revise SOP’s covering clinical supplies, meeting industry and regulatory standards
  • Support regulatory filings including IND submission information and audits from all health agencies
  • Coordinate with Quality on IMP investigations
  • Design, implement and oversee return and destruction of IMPs from sites
  • Oversee temperature excursion and resolution during transportation and coordinate with Quality on any investigations
  • Comply with company regulatory, safety and compliance procedures and practices
  • May be assigned other projects and duties as required

     

    SUPERVISOR RESPONSIBILITES:
  • Directs and controls the activities of a broad functional area typically, but not always, through several department managers.
  • Has overall control of planning, staffing, budgeting, managing expense priorities, and recommending and implementing changes to methods.

Qualifications

  • Bachelor’s degree (BA/BS)
  • 6 to 10 years’ experience in Supply Chain/Clinical Supply Chain or relevant experience in CMC or CMC Project Management.
  • Ability to effectively interact with all levels of internal and external management, including CROs
  • Demonstrated excellence in project management and managing, tracking, and measuring project progress
  • Clinical Supply management experience using CMOs
  • Strong understanding of the US, CA, and EU clinical supply regulations. Knowledge of other global clinical supply requirements are a plus.
  • Working knowledge of regulations relating to clinical labeling, packaging and distribution activities (cGMP, GCP)
  • A track record of successfully managing multiple projects within a GxP related environment
  • Ability to manage timelines and prioritize task execution based on business need
  • Possesses excellent organizational, project management, technical, problem solving and communication (written & verbal) skills
  • Ability to think both strategically and tactically with exceptional attention to detail
  • Demonstrated ability to manage multiple high-priority projects concurrently in an ever-changing environment
  • Able to work with a range of technically and culturally diverse people, influencing them to get the job done, and delivering value-added business results that meet high quality requirements within a tight schedule

 

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