Senior Director, Supply Chain

Role Summary:

We are seeking an experienced Director, Supply Chain, to join our growing Technical Operations team. You will be responsible for developing and implementing clinical supply chain procedures and infrastructure to support the upcoming pipeline of projects. You will also be responsible for developing clinical supply chain strategies ensuring availability of supply through development and commercial launch, as well as transferring sustaining activities to the appropriate site planning. This individual also ensures uninterrupted supplies throughout the duration of a clinical study program based upon related targets and regulatory requirements in addition to providing CMO vendor oversight.

Key Responsibilities:

• Lead a team to 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, clinical/master batch record, clinical trial protocol, pharmacy manual, IND, IMPD, and NDA
• Lead vendor identification, selection, onboarding, and management for combo agent/comparator sourcing and secondary packaging and distribution
• 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)
• 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. Publishes monthly inventory reports for all products
• Oversees activities relating to the labeling, packaging, and distribution plans for each study based on protocol requirements and factors such as regulatory requirements, blinding concerns, ease of handling by the sites and patients, and patient compliance
• 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 10+ 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
• Strong analytical and critical thinking skills
• Proficient in data analysis tools and software
• Detail-oriented with a knack for identifying trends and anomalies
• Strong leadership skills with experience in managing and mentoring a high-performing team
• Excellent communication skills and the ability to work effectively in a fast-paced environment
• Experience in a small company or start-up environment is preferred

What We Offer

• Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture of our young company, wear multiple hats, 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 year.
• Commitment to growing you professionally and providing access to resources to further your development.
• 100% remote with frequent all team, in-person meetings to build relationships and problem solve.

The expected salary range offer for this role is $210,000 to $235,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.