Manager, Global Clinical Supply Chain Planning

About the role

Responsible for developing end-to-end supply plans for innovative medicines in clinical development. The Manager, Planning Lead will attend clinical project meetings to gather relevant information, translate clinical trial protocol information into a study supply plan, forecast study product requirements, and interact and negotiate with key project stakeholders to provide delivery timelines and budget.

Maintains an enterprise view of the 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.

Responsibilities

• Primary interface between clinical supply stakeholders, including Clinical Operations, Pharmaceutical Sciences (PS), GSQ, Clinical Supplies operations, and Quality Assurance.
• Interfaces with Pharmaceutical Sciences group to ensure trial supplies are appropriately supported, stability programs are in-progress, and appropriate expiry dating exists.
• Works closely with Logistics function to proactively 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.
• Develops Operational Supply Plans for a portfolio of development products, both internal and acquired through external partnerships.
• Oversees forecast planning and inventory management of all relevant investigational medicines and comparators for the portfolio, leading in a matrix of SMEs spanning Takeda supply chain, Takeda pharmaceutical sciences organizations, and external partners.
• Leads 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.
• Develops and maintains detailed clinical supply models for supply scenarios, providing a study baseline to monitor assumptions and inventories of finished goods in ongoing clinical trials.
• Leads establishment of an enterprise approach to supply/demand modeling, risk identification, and scenario planning for the clinical supply chain; leads cross-functional planning teams to respond to unplanned events.
• Develops supply options, facilitates decision-making, and communicates updated manufacturing and supply plans to all impacted stakeholders.
• Responsible for execution of the Operational Supply Plan throughout the development lifecycle, identifying leading indicators of supply risk and escalating through PS Lead and GPL to course correct.
• Liaises 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 SmartSignals software to request packaging/labeling/distribution jobs, manage inventory, and shipments.
• Provides input into Interactive Response Technology (IRT) design for randomization, supplying drug to depots and sites.
• Contributes to process improvements.

Requirements

• Degree in Engineering, Management, Pharmacy, or other scientific/technical degree, or significant job-related experience.
• 4+ years of relevant Pharmaceutical Industry and/or Contract Provider experience; completion of a 2-year Post-PharmD Fellowship or MBA is preferred.
• Experience with Medical Devices is a plus.
• Basic understanding of GxP principles and/or ability to learn key GxP methodology.
• Proficiency in computer software applicable to IRT and Excel; MS Project or equivalent project management software is a plus.
• 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.
• Must be aware of and compliant with regulations and requirements for functioning under GMP, GDP, GCP’s, Annex 6, EU CT Directive, and DEA or local controlled-substance regulations as required.

Skills

• Good communication, organizational, and team collaboration skills.
• Ability to work effectively with global work associates.
• Ability to interact effectively at high levels between customers and suppliers, manage and resolve issues, and provide effective feedback.
• Ability to handle multiple projects simultaneously while maintaining high-quality results.
• Ability to recognize potential conflict and escalate when necessary.
• Strong presentation skills; ability to give professional and concise presentations at internal and external meetings.

Pay

For Location: Boston, 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 qualifications, 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.

Benefits

• Eligibility for short-term and/or long-term incentives.
• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.

Schedule

Full time, exempt position.

Location: Boston, MA.