Manager, Global Clinical Supply Chain Planning

About the role

The Manager, Planning Lead is responsible for developing end-to-end supply plans for innovative medicines in clinical development. They attend clinical project meetings to gather relevant information, translate clinical trial protocol information into a study supply plan, forecast study product requirements, interact and negotiate with key project stakeholders to provide delivery timelines and budgets. They maintain an enterprise view of the clinical supply chain, connecting CMC, clinical operations, and commercial manufacturing perspectives across the development portfolio.

Responsibilities

• Attends clinical project meetings to gather relevant information and translate clinical trial protocol information into a study supply plan.
• Forecasts study product requirements and interacts with key project stakeholders to provide delivery timelines and budgets.
• Maintains an enterprise view of the clinical supply chain, connecting CMC, clinical operations, and commercial manufacturing perspectives across the development portfolio.
• Develops scenario planning, clinical supply recommendations, and risk mitigation through detailed insight of supply and demand issues for assigned clinical programs.
• Interfaces with Pharmaceutical Sciences group to ensure trial supplies are appropriately supported and appropriate stability programs are in progress, and/or 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 and maintains 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.
• 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.
• 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 the ClinApps Clinical Supplies Management Database (CSMD) to request packaging/labeling/distribution jobs, to manage inventory, and to facilitate shipment.

Requirements

• 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, and to manage and resolve issues.
• Ability to provide effective feedback.
• Ability to handle multiple projects simultaneously while maintaining high quality results.
• Ability to recognize potential conflict and escalate when necessary.

Qualifications

• Education: Degree in Engineering, Management, Pharmacy or other scientific/technical degree, or significant job-related experience.
• Experience: 4+ years relevant Pharmaceutical Industry and/or Contract Provider experience, completion of 2-year Post-PharmD Fellowship experience in, or MBA is preferred.
• Skills: Basic understanding of GxP principles and/or ability to learn key GxP methodology.

Skills

• Communication skills.
• Organizational skills.
• Team collaboration skills.
• Interpersonal skills.
• Problem-solving skills.
• Project management skills.
• Technical skills: Proficiency in computer software applicable to IRT, Excel, MS Project or equivalent project management software.

Benefits

Takeda offers competitive compensation and comprehensive benefits packages. The base salary range for this position is $116,000.00 - $182,270.00. Employees may be eligible for short-term and/or long-term incentives, 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. 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. Takeda is committed 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.