Director, Global Supply Chain

At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.
 
We are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.

What You’ll Do:

The Director, Global Supply Chain reports to the Senior Director, Global Supply Chain and possesses a working understanding of commercial and clinical supply management and strategy, global regulatory requirements, and project management practices. The Director, Global Supply Chain partners with relevant internal functional groups to ensure uninterrupted supply of both Investigational Medicinal Product (IMP) for clinical studies as well as inventory of commercial drug products.

Required location: Waltham, MA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Support commercial launch readiness, including vendor management, distribution planning, and leading the Supply and Operations Planning team
• Managing drug product supply and logistics activities including, but not limited to, demand forecasting and supply planning (clinical and commercial), IRT, label generation and approval, packaging and labeling operations, release and distribution, expiry extension, cold chain management, and inventory management
• Communicating supply strategies and supply needs to CMC stakeholders and providing input for developing manufacturing strategies to support those needs
• Providing oversight in monitoring inventory levels throughout the life of a clinical trial or commercial product, including taking preventative actions to avoid potential supply issues
• Providing day-to-day oversight of Packaging and Labeling/Distribution vendors, including relationship management
• Contributing to the preparation of clinical protocols, clinical trial pharmacy manuals, packaging methods, batch records, drug labels, shipping documents, destruction certification, and coordinating the origination, proofing, and translation of clinical study labels and generation
• Proactively identifying potential issues, notifying Management in a timely manner, and developing mitigating actions
• Coordinate the development of the commercial forecast
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts and develop supply plans
• Oversee the execution of multiple clinical trials and proactively identify potential supply chain issues, including providing analysis and recommending solutions with appropriate support from SMEs
• Support clinical study close-out activities, including returned goods reconciliation and inventory destruction
• Manage and execute drug supply delivery through coordination of CMC efforts assigned to the entire project team (including but not limited to CMC, Supply Chain, Legal, Procurement, Commercial, Regulatory, Clinical Development, and Clinical Operations)
• Ensure temperature excursion processes are executed as required
• Guide the IRT System Leads as necessary with regards to user requirement specifications and management module(s) as applicable
• Leverage inventory management capabilities of the IRT to appropriately manage clinical and commercial drug supply

Required Qualifications:

• Experience with global pharmaceutical development and manufacturing operations for development-stage and commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
• Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or an advanced degree with 8+ years
• 8+ years of experience in clinical supply management
• Ability to cross-functionally communicate effectively with a high degree of emotional intelligence
• Deep understanding of IRT systems
• Ability to create a collaborative environment and manage multiple project activities with global contract CDMOs
• Strong computer skills including MS Office
• Hands-on, roll-up-your-sleeves, collaborative approach with a high sense of urgency and personal accountability to drive toward results
• Ability to think outside of the box and challenge the status quo
• Desire to work in a fast-paced, innovative environment
• Domestic or international travel is required (up to 20%)

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