Posted to MedZilla on 2/16/2020

Takeda Pharmaceuticals

US-MA, Sr. Clinical Supplies Specialist SR0045271-MZ


Under the direction of the Clinical Supplies (CS) Lead, the Clinical Supplies Senior Specialist

develops strategy and manages the supply and distribution of clinical material to investigators by interacting with both internal Clinical Supply project managers and external customers and suppliers in order to accomplish project objectives.

  • This person will play a critical role in collaborating with external clinical manufacturing, distribution and comparator ourcing vendors.

    - This role will have an opportunity to gain increasing knowledge and responsibility in managing clinical supply activities supporting critical studies
  • Collaborates with Takeda Clinical Supplies project managers to develop IMP distribution and return drug plans and monitors contractor adherence, in conjunction with using established electronic systems for supply, inventory management, and returns.
  • Monitors inventory levels and provides feedback to project manager regarding expiry and re-supply, if required. Leads and participates in Takeda Global Clinical Supplies group initiatives.
  • Support Clinical Supply Chain team in planning and executing the manufacture and global distribution of clinical material to clinical trial sites
  • Oversight and coordination of vendor activities supporting the packaging/labeling and distribution of clinical supplies to investigators
  • Managing the the Procure to Payment process for Clinical Supply Vendor activities including oversight of the purchase order creation through support of the invoice payment process
  • Participate and organize vendor collaboration meetings and facilitate the communications between the vendors and various internal and external stakeholders involved in the process


  • Demonstrates proficiency in utilization of appropriate internal Clinical Supply databases, such as the ClinApps suite of software to facilitate the supply and distribution of clinical material to investigators and return from same.
  • Interacts with contractors and internal Takeda customers to monitor progress and to troubleshoot when required.
  • Leads distribution and return projects by collaborating with CS managers and by interfacing with Clinical Supplies Technologies Team to understand Takeda Interactive Response Technology (IRT) and internal database standards and requirements.
  • Provides project based input into (IRT) design and development for return functionality if used and leads user acceptance testing efforts.
  • Facilitates transfer and reconciliation of returned clinical supply drug from investigational sites using the appropriate internal database software or IRT service.
  • Interacts with contractors and internal Takeda customers to monitor progress and to troubleshoot when required.
  • Maintains Clinical Supply IMP project binders and product specification files in an audit-ready state ensuring inclusion of essential documentation and archiving of interim working notes. Coordinates pre-audit/inspection review.
  • Utilizes the internal database to manage Clinical Supply inventory for projects assigned. Compares periodically to vendor inventory to ensure accuracy and that final product reconciliation is accurately completed.
  • Support the development and execution of clinical supply chain manufacturing orders and distribution setups
  • Manage shipping logistics issues and temperature excursions for clinical materials en route or at the clinical site
  • Provide data entry support for inventory transactions
  • Support inventory reconciliation, documentation management and other key activities required for inspection readiness
  • Communicate with and provide direction to clinical supply vendors
  • Ensure that quotes are entered into Ariba and facilitate the process through Purchase Order approval
  • Work closely with vendors to help troubleshoot invoice/payment issues and support the study manager/leads in reviewing and approving invoices
  • Provide tools for the study leads/managers to assess study budgets and purchase order needs and help ensure these are routinely reviewed

Education and Experience Requirements:

  • Bachelor's degree preferred in Scientific, business or supply chain (or significant progress toward achieving a degree) preferred.
  • Three five years of related Pharmaceutical Industry or contract Provider experience and applicable Clinical Supplies experience
  • Ability to organize and manage multiple priorities at the same time is extremely important.
  • Ability to effectively communicate and maintain positive relationships with vendors and stakeholders is citical to success for this role.
  • Ability to learn and master key systems (supply chain management as well as procurement systems) is required.

Key Skills, Abilities, and Competencies:

  • Previous exposure to one or more of the following: GXPs, Clinical trial management, Supply Chain principles will be extremely helpful for this individual to be successful

  • Excellent communication and organizational skills.This person will be communicating and collaborating with multiple stakeholders from different functional groups and organizations that will have competing priorities and hence needs to be diplomatic and adept at influencing others
  • Ability to lead team projects and interact effectively between customers and suppliers to manage and resolve issues.
  • Troubleshoots supply and return issues in-progress, proposes corrective action for implementation, and monitors conformance.
  • Must be aware and compliant to DEA regulations and requirements for functioning under GMP, GCP, and GDP s and Annex 13 and EU CT Directive, as required.

Complexity and Problem Solving :

This person will support the entire range of our clinical portfolio so a basic understanding of the types of modalities and their impact on supply management is useful.

  • Understanding the business drivers and practices of our key vendors will be required to be successful in managing these vendor relationships.
  • Requires some supervision and oversight but with minimal repeat of requirements.
  • Work is routinely reviewed by CS managers and with supervisor during periodic project review meetings.
  • Communication between customers and suppliers is freely conducted as required for project need with update to supervisor and relevant project managers periodically.
  • Seeks innovative solutions to complex problems
  • Decisions affecting supplies form, delivery, and timing are done in collaboration with responsible CS manager or supervisor
  • Position has budgetary responsibility up to established DOA

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

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Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

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