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.
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.
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.
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.
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.
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.

Requirements

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.

Benefits

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.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical supply planningdemand forecastingsupply planninginventory managementcold chain oversightdrug product formulationpackaging operationsregulatory submissionscost forecastingclinical documentation

Soft Skills

leadershipcommunicationdecision-makinganalytical skillsproblem-solvinginfluencingcross-functional collaborationstrategic mindsetperformance managementrisk identification