Associate Director, Global Clinical Supply Chain

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and implement the comprehensive project delivery by coordinating CMC efforts across CMC, Supply Chain, Legal, Procurement, Regulatory, Clinical Development, and Clinical Operations.

• Offer insights on packaging design, distribution, and blinding strategies.

• Organize and oversee initial supplies and resupplies for designated studies.

• Create and execute plans to supply study drugs for complex global clinical trials.

• Formulate and implement inventory management strategies for clinical sites and depots.

• Analyze clinical synopses and protocols to generate clinical forecasts.

• Collaborate with Clinical Operations to execute supply chain inventory management.

• Identify potential supply chain challenges, evaluate them, and propose solutions.

• Conduct study closeout tasks, including reconciliation of returned goods, processing of inventory destruction, and archiving of files.

• Oversee inventory and shipment logistics for Immunovant products and related samples.

• Ensure compliance with temperature excursion protocols as required.

• Communicate with suppliers to manage relationships, facilitate rapid startups, address issues, and answer CMC project inquiries.

• Review and modify IRT strategy and settings to enhance supply chain operations.

• Utilize IRT inventory management features to oversee studies.

• Execute all necessary actions to guarantee efficient clinical supply chain operations for assigned trials.

⛳️ Requirements

• Bachelor's degree in science, engineering, or a related field; advanced degree is preferred.

• More than five years of relevant experience in the pharmaceutical or biotech industry.

• Familiarity with global pharmaceutical or biotech development and manufacturing operations for development-stage biologics, including upstream/downstream process development, formulation development (pre-filled syringe), analytical development, and device development.

• Experience overseeing diverse project activities with contract CMO facilities across various global locations.

• Background in clinical supply management.

• Exceptional project management capabilities; proven track record of working independently, prioritizing tasks, and managing multiple responsibilities simultaneously.

• Proficient in computer skills, including MS Office and SmartSheets.

• Practical, hands-on approach with a strong sense of urgency and a results-driven attitude.

• Proven communication, problem-solving, leadership, and decision-making abilities.

• Capacity to think creatively and challenge conventional practices.

• Innate entrepreneurial spirit with unwavering commitment to achieving results.

• Enthusiasm for working in a dynamic and innovative environment.

• Natural collaborator who enjoys participating in a cross-functional team.

🏝️ Benefits

• Equity and other compensation options may be included as part of the overall compensation package.

• Medical benefits.

• Dental benefits.

• Vision benefits.

• 401k.

• Unlimited paid time off.

• Parental leave.

• Flexible work environment.