Posted to MedZilla on 10/13/2019

Takeda Pharmaceuticals

US-MA, Clinical Supplies Sr. Planning Lead SR0040443-MZ


Primary Duties:
The Clinical Supplies Sr. Planning Lead is responsible for providing leadership and direction to facilitate the planning and execution of Clinical Supply Chain activities globally. Under the direction of the Clinical Supplies Director, the Clinical Planning Lead manages Clinical Supply project delivery in support of Takeda Global R&D Clinical Trials and other supportive research or development needs; coordinates, procures and manages drug product supply, packaging, labeling, distribution, return, reconciliation, and destruction activities of Investigational Medicinal Products. Works with both internal and external customers and suppliers in order to develop and communicate clinical supply project budgets and plans and to ensure that all project objectives are met in a timely and compliant manner. The Clinical Supplies Sr Planning Lead may also have personnel management and compensation planning responsibility and contributes actively to cross functional teams as required.


  • Works with Clinical Supplies Planning function to interpret clinical trial drug requests and Clinical Protocols and develops supply packaging strategies, timelines, plans, and budgets.
  • Utilizes the ClinApps Clinical Supplies Management Database (CSMD) for clinical labeling approval, to request packaging/labeling/distribution jobs, to manage inventory, shipments, and drug return activities.
  • Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites, and for return functionality.


  • Coordinates primary and secondary packaging, labeling, testing, IVR, distribution, return drug management activities with contract providers according to approved budget.
  • Ensures that costs are accrued properly, that budget is reviewed periodically and managed appropriately, and that invoices are paid expeditiously. Ensures that activities are performed at contract providers in accordance with expectations, regulations, and quality standards.


  • Works with Clinical Supplies Specialists and/or Coordinators to manage and troubleshoot shipment requests and drug returns when required. Works with them to ensure creation and maintenance of Clinical Supplies IMP documentation and product specification files (where required) according to established procedures and to manage IMP inventory for projects assigned.
  • When required, attends cross functional team meetings for projects assigned.


  • Interfaces with appropriate Takeda Clinical and Regulatory R&D and project teams to design IMP supply strategies in order to successfully accomplishing research needs..
  • Interfaces with appropriate QA personnel to facilitate expeditious release of IMP and/or sites.
  • Interfaces with Product Development group within Pharmaceutical Sciences to ensure bulk IMP supply for research needs, that appropriate stability programs are in-progress, and/or appropriate expiry dating exists.
  • Works closely with Logistics function to pro-actively plan, document, and facilitate global cross-border supply strategies, including requirements associated with controlled substances, compliance to global trade standards, and in-country investigational product regulatory requirements for delivery of product to final destinations.


  • Coaches and mentors less experienced staff.
  • Evaluate current processes, identify, and implement improvement opportunities and implement business processes related to the Clinical Supplies Team as required.

Education and Experience Requirements:

  • Degree in Pharmacy, other scientific/technical degree, or significant job related experience.
  • 8-12 years relevant Pharmaceutical Industry and/or Contract Provider experience is preferred.
  • Experience with Medical Devices a plus
  • Strong understanding of cGMP requirements, Proficiency in computer software applicable to IVRS/IWRS, Excel and MS Project or equivalent project management software is a plus

Key Skills, Abilities, and Competencies:

  • Excellent communication, organizational, and team building skills.
  • Must work effectively with global work associates.
  • Ability to interact effectively at high levels, between customers and suppliers, and to manage and resolve issues and to provide effective feedback.
  • Must be able to handle multiple projects simultaneously while maintaining high quality results.
  • Must provide and implement innovative solutions to unique situations.
  • Must be able to recognize potential conflicts and escalate when necessary.
  • Must be aware and compliant to regulations and requirements for functioning under GMP, GCP s, Annex 13 and EU CT Directive, and DEA or other local controlled-substance regulations, as required.

Complexity and Problem Solving:

  • Ability to work independently on projects assigned, however project work is routinely reviewed by Director. Must translate Clinical research protocol concepts into effective and subject-friendly packaging strategy.
  • Shares information freely with global work group.
  • Communication between customers and suppliers is generally not monitored.
  • Position has responsibility for projecting annual budget for IMP preparation and fulfillment for assigned project.
  • Able to authorize spending up to established DOA.
  • Must refer up when required any decisions impacting agreed upon timelines and/or budget.

Other Job Requirements:

  • Travel to local contractors is required in order to ensure project success.
  • Travel is required to investigator meetings when requested by Clinical research team.
  • International travel may be required in support of project activities.

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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Pay Transparency Policy -

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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