Senior Manager, Clinical Trial Supplies

Role Overview

• Develop and lead end-to-end clinical supply strategies for multiple clinical programs and phases (Phase I–IV)
• Design optimized supply models, including labeling, packaging, distribution, and inventory strategies
• Assess and mitigate supply risks, including demand uncertainty, enrollment variability, and manufacturing constraints
• Manage clinical trial supply lifecycle activities, including forecasting, demand planning, packaging, labeling, distribution, returns, and destruction
• Ensure uninterrupted supply of investigational and comparator products to global clinical sites
• Manage Interactive Response Technology (IRT) system builds, UAT testing, supply strategies and reconciliation activities
• Partner closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors as required to ensure alignment on study timelines and deliverables
• Serve as the clinical supply representative on study teams and governance forums
• Influence study design decisions to optimize supply chain efficiency and patient experience
• Lead selection, contracting, and performance management of external vendors (CMOs, depots, couriers, IRT providers)
• Develop and manage clinical supply budgets, vendor quotes, proposals, and timelines
• Drive cost optimization while maintaining quality and compliance
• Confirm production plans and shipping schedules; develop depot/site resupply strategies and coordinate packaging schedules with third-party provider(s) to support clinical demand changes
• Work with third-party providers to develop detailed project plans and timelines for the packaging, release, and distribution of clinical supplies
• Coordinate the review and approval of provider documentation (distribution instructions, label proofs, packaging specifications and methods, packaging batch records, etc.)
• Plan and oversee the implementation of expiry date extensions
• Coordinate the assessment of and track temperature excursions during storage, receipt, or transit to clinical sites or depots
• Support the transportation and disposition of returned/unused materials, as needed
• Manage activities needed to source comparators and ancillary products. Plan supply strategies, labeling and distribution activities
• Support the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, disposition of returned/unused materials, etc.
• Support CMC team as needed
• Other duties as assigned.

Requirements

• Minimum of a Bachelor’s in life sciences, nursing, business or related field with at least 12 years of related technical experience
• Alternatively, a Master’s degree with 8 years of experience (an equivalent combination of experience and education may be considered)
• Previous experience in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination
• Previous experience in rare diseases/oral solid dosage forms is a plus
• Import and export management of drug substance and drug product
• Understanding of CGMP and CGCP requirements, compendia testing, and ICH and regulatory guidelines including stability data requirements
• Excellent interpersonal and communication skills (written and oral)
• Experience with preparation of regulatory documents is desired
• Excellent ability to work in a goal and team-oriented setting and to handle competing priorities
• Flexibility within a rapidly changing environment and high attention to details
• Well-developed organizational skills and the ability to thrive under pressure
• Well-versed in industry trends, emerging business processes and technologies.

Benefits

• discretionary annual target bonus
• stock options
• ESPP
• 401k match
• top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
• 20 days of PTO
• 10 paid holidays
• winter company shutdown