Director, Drug Product & Supply Chain

Role Summary:

The Director, Drug Product Clinical Supply Chain is a senior leadership role within Technical Operations responsible for the end-to-end strategy, execution, and continuous improvement of clinical drug product supply across global development programs. This role ensures uninterrupted, compliant supply of drug product from formulation through packaging, labeling, release, and distribution, while building scalable capabilities to support clinical development towards commercial launch.

The Director serves as the primary drug product supply chain leader for one or more global clinical programs and partners closely with CMC, Quality, Regulatory, Clinical Operations, Finance, and executive leadership, as well as external CMOs and vendors.

Key Responsibilities:

Strategic Drug Product Supply Leadership

• Own the global clinical drug product supply strategy for assigned programs, ensuring alignment with clinical development timelines, regulatory requirements, and corporate objectives.
• Lead end-to-end clinical supply planning and execution to ensure uninterrupted, on-time, and compliant delivery of drug product throughout global clinical trials.
• Provide strategic direction for scaling drug product supply capabilities from Phase 2 through Phase 3 and commercial readiness.

Clinical Supply Chain & Operations Oversight

• Direct all clinical drug product supply chain activities, including demand forecasting, supply planning, IRT support, labeling strategy, packaging and labeling operations, release, distribution, inventory management, expiry strategy, and cold chain oversight.
• Establish and maintain robust processes, systems, and controls to ensure compliance with GMP, GDP, and global regulatory requirements.
• Perform short-, medium-, and long-term supply forecasting and oversee monthly forecasting and production planning cycles.

Drug Product Technical Operations

• Provide senior technical oversight of drug product formulation, manufacturing, packaging, and labeling activities conducted by external CMOs.
• Evaluate and implement new technologies, systems, and delivery approaches to improve supply robustness, efficiency, and scalability.
• Ensure technical and supply chain readiness for regulatory submissions and inspections.

Vendor & Partner Leadership

• Lead CMO and vendor strategy, including selection, contracting, performance management, change control, and issue resolution across all outsourced drug product supply activities.
• Oversee procurement of comparator drug products and matching placebo, as required.
• Build strong, performance-driven partnerships with external vendors to support clinical and future commercial needs.

Quality, Compliance & Continuous Improvement

• Provide leadership oversight of quality-related activities impacting clinical drug product supply and participate in quality improvement initiatives.
• Serve as a senior subject matter expert in clinical supply GMP, GDP, and related business processes.
• Proactively identify risks, trends, and opportunities for continuous improvement across drug product technical operations and supply chain processes.

Documentation, Budget & Cross-Functional Leadership

• Author, review, and approve clinical and technical documentation, including clinical labels, packaging batch records, protocols, pharmacy manuals, and regulatory submissions (IND, IMPD, NDA).
• Own clinical drug product supply budgets for assigned programs, ensuring accurate cost forecasting and alignment with inventory and demand strategies.
• Act as a key cross-functional leader, providing clear communication, decision-making, and guidance to internal teams and senior management.
• Other duties as assigned

Ideal Candidate:

• Bachelor’s degree or advanced degree in a scientific, engineering, or related discipline.
• 10+ years of experience in pharmaceutical or biotech drug product technical operations and clinical supply chain, with demonstrated leadership responsibility.
• Proven experience leading global clinical drug product supply for complex Phase II/III randomized, I&I and/or IBD clinical trials.
• Strong working knowledge of GMP, GDP, GCP, and global import/export regulations related to clinical drug product supply.
• Demonstrated success managing complex, outsourced drug product supply chains and CMO relationships.
• Strategic mindset with strong analytical, problem-solving, and decision-making capabilities.
• Excellent communication and leadership skills with the ability to influence cross-functional teams and senior stakeholders.
• Experience in a small or emerging biotech environment 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 $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.