Manager, Global Clinical Supply Chain Planning

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Job Description

Manager, Global Clinical Supply Chain Planning

OBJECTIVES/PURPOSE:

• Responsible for developing end-to-end supply plan for innovative medicines in clinical development. The Manager, Planning Lead will attend clinical project meetings to gather relevant information, translating clinical trial protocol information into a study supply plan, forecast study product requirements, interacting and negotiation with key project stakeholders to provide delivery timelines and budget.
• Maintains enterprise view of clinical supply chain connecting CMC, clinical operations, and commercial manufacturing perspectives across the development portfolio.
• Responsible for scenario planning, clinical supply recommendations, and risk mitigation through detailed insight of supply and demand issues for assigned clinical programs.

ACCOUNTABILITIES:

• The Manager, Planning Lead will be a primary Interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences (PS), GMS, Clinical Supplies operations and Quality Assurance.
• Interfaces with Pharmaceutical Sciences group to ensure that trial supplies are appropriately supported and 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.
• Develop Operational Supply Plans for portfolio of development products both internal and acquired through external partnerships. Oversee forecast planning and inventory management of all relevant investigational medicines and comparators for portfolio, leading in matrix of SMEs spanning Takeda supply chain, Takeda pharmaceutical sciences organizations and external partners.
• Lead operational feasibility assessment, scenario analysis and risk mitigation for new clinical protocols, representing the clinical supply chain to global PS teams and global program teams.
• Develop and maintain detailed clinical supply models for supply scenarios which provides a study baseline against which to monitor assumptions and inventories of finished goods in ongoing clinical trials.
• Lead establishment of enterprise approach to supply/demand modelling, risk identification, and scenario planning for clinical supply chain, lead cross functional planning teams to respond to unplanned events. Develop supply options, facilitate decision making, and communicate updated manufacturing and supply plans to all impacted stakeholders.
• Responsible for execution of Operational Supply Plan throughout development lifecycle, identifying leading indicators of supply risk and escalating through PS Lead and GPL to course correct.
• Liaise among Clinical Operations, Pharmaceutical Sciences, and Procurement disciplines in planning and managing appropriate levels of CTM and comparator supply in partnership with internal and external stakeholders.
• Utilizes the ClinApps Clinical Supplies Management Database (CSMD) to request packaging/labeling/distribution jobs, to manage inventory, shipments."

CORE ELEMENTS RELATED TO THIS ROLE:

• Good communication, organizational, and team collaboration 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 be able to recognize potential conflict and escalate when necessary.
• Presentation Skills- ability to give professional and concise presentations at internal and external meetings
• Must be aware and compliant to regulations and requirements for functioning under GMP, GDP, and GCP’s and Annex 13 and EU CT Directive, and DEA or local controlled-substance regulations as required.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Degree in Engineering, Management, Pharmacy or other scientific/technical degree, or significant job-related experience.
• 4+ years relevant Pharmaceutical Industry and/or Contract Provider experience, completion of 2-year Post-PharmD Fellowship experience in, or MBA is preferred.
• Experience with Medical Devices a plus.
• Basic understanding of GxP principles and/or ability to learn key GxP methodology
• Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites.
• Proficiency in computer software applicable to IRT, Excel
• MS Project or equivalent project management software is a plus
• Contribute to process improvements
• Ability to influence stakeholders from many technical disciplines and at many levels.
• Ability to apply multiple lenses to analyze and represent complex interdependencies, scenarios, and tradeoffs."

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

Lexington, MA

U.S. Base Salary Range:

$116,000.00 - $182,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.