Director, Supply Chain

Role Summary:

We are seeking an experienced Director, Supply Chain, to join our growing Supply Chain team within Technical Operations. You will be responsible for ensuring uninterrupted clinical supply throughout the duration of a clinical study program based upon related targets and regulatory requirements in addition to providing CMO vendor oversight. The role will take leadership for one or more of our global Phase 2 studies and continue to build our supply chain function and processes towards Phase 3 and commercial launch.

Key Responsibilities:

• Plan and deliver on-time, compliant clinical supply per the clinical development plan
• Serve as the clinical supply lead for assigned program(s) and develop/manage the clinical supply plan
• Lead and manage clinical 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
• Author, review, and/or approve related clinical and technical documents, including but not limited to: clinical label text, packaging batch records, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA
• Manage existing clinical supply vendors through quoting, execution, changes, and close out, ensuring high performance delivery across all outsourced activities
• Support new vendor identification, selection, and onboarding for future phases and/or capabilities
• Serve as a subject matter expert and develop continuous improvement plans for clinical supply GMP, GDP, and business processes
• Responsible for oversight of scheduling and delivery of clinical supplies including strategies for creating label and packaging design, randomization, packaging, labeling and distribution in compliance with Good Manufacturing Practices (GMP) regulations
• Performs supply forecast modeling (short, medium and long-term) and supports monthly forecasting and production process
• Ensures product requirements and costs for the budget are complete and in place for assigned projects
• Evaluates the impact of changing the inventory targets, clinical demand, and budget restrictions.
• Manages the procurement of comparator drug products and matching placebo as required
• Other duties as assigned

Ideal Candidate:

• Bachelor's degree or advanced degree in scientific fields with 8+ years of experience in clinical supply chain and logistics
• Strong experience managing clinical supply activities for global phase 3, randomized, I&I and/or IBD clinical trials
• Working knowledge of import and export laws and processes, GMP and GCP requirements related to clinical supply
• Highly organized with the ability to manage many different types of tasks and inputs at once
• Strong analytical and critical thinking skills
• Excellent communication skills and the ability to work effectively in a fast-paced environment
• Proficient in data analysis tools and software
• Detail-oriented with a knack for identifying trends and anomalies
• Experience in a small company or start-up environment is preferred

What We Offer:

• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Unlimited PTO
• Two, one-week company-wide shutdowns each
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $205,000 to $229,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.