Director, Global Supply Chain

Kailera is seeking a Director, Global Supply Chain to join their team, committed to developing therapies for obesity and related conditions. This role reports to the Senior Director, Global Supply Chain and requires a strong understanding of clinical supply management, global regulatory requirements, and project management. The Director will partner with internal groups to ensure uninterrupted supply of Investigational Medicinal Product (IMP) for clinical studies and inventory of commercial drug products, contributing to Kailera's mission in a collaborative and inclusive environment.

Must Have

• Manage drug product supply and logistics activities (demand forecasting, supply planning, IRT start-up, label generation, packaging, release, distribution, expiry extension, cold chain management, inventory management)
• Communicate supply strategies and needs to CMC stakeholders
• Oversee inventory levels throughout clinical trials or commercial product life
• Provide day-to-day oversight of packaging and labeling/distribution vendors
• Contribute to preparation of clinical protocols, pharmacy manuals, batch records, drug labels, shipping documents, destruction certification
• Proactively identify potential issues and develop mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• Oversee execution of multiple clinical trials and identify supply chain issues
• Support clinical study close-out activities (returned goods reconciliation, inventory destruction)
• Manage and execute drug supply delivery by coordinating CMC efforts across project team
• Ensure temperature excursion processes are executed
• Guide IRT System Leads on user requirement specifications and management module(s)
• Leverage IRT inventory management capabilities
• Bachelor’s degree and 10+ years of relevant biopharmaceutical industry experience or advanced degree with 8+ years
• 8+ years of experience in clinical supply management
• Experience with global pharmaceutical development and manufacturing operations
• 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
• Domestic or international travel up to 20% is required

Good to Have

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Perks & Benefits

• Comprehensive health coverage
• Flexible time off
• Paid holidays
• Year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Tuition reimbursement
• Commuter benefits
• Disability and life insurance
• Annual bonus opportunities
• Equity grants

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 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 or San Diego, CA (hub-based, onsite 3-4 days per week)

Responsibilities:

• Managing drug product supply and logistics activities, including, but not limited to, demand forecasting and supply planning, IRT start-up and maintenance, 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 identify potential issues, notify management in a timely manner, and develop mitigating actions
• Interpret clinical synopses and protocols to create clinical IMP demand forecasts
• 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:

• 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
• Experience with global pharmaceutical development and manufacturing operations for development-stage and/or commercial products, including formulation development (pre-filled syringes, solid oral dosage forms, etc.), analytical development, and device development
• 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 high sense of urgency and drive for 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%)

Preferred Qualifications:

• Experience with pharmaceutical development and manufacturing operations for development-stage clinical products
• Experience with combination product device(s)

Education:

• Bachelor’s degree in pharmaceutical science, engineering, life sciences, or another relevant field. Advanced degree preferred.

Salary Range

$175,000 - $230,000 USD

This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants—because your well-being and future matter to us.