Senior Manager, Clinical Trial Supplies

This is a fully remote position, open to applicants in California.

📋 Description

• Develop and oversee comprehensive clinical supply strategies for various clinical programs and phases (Phase I–IV).

• Create optimized supply models that encompass labeling, packaging, distribution, and inventory strategies.

• Evaluate and mitigate supply risks, including demand fluctuations, enrollment variability, and manufacturing limitations.

• Manage the lifecycle of clinical trial supplies, including forecasting, demand planning, packaging, labeling, distribution, returns, and destruction.

• Ensure a consistent supply of investigational and comparator products to clinical sites worldwide.

• Oversee Interactive Response Technology (IRT) system builds, user acceptance testing (UAT), supply strategies, and reconciliation activities.

• Collaborate closely with Clinical Operations, Manufacturing, Quality, Regulatory Affairs, Finance, and external vendors to ensure alignment on study timelines and deliverables.

• Act as the clinical supply representative on study teams and governance forums.

• Influence study design decisions to enhance supply chain efficiency and improve patient experience.

• Lead the selection, contracting, and performance management of external vendors (CMOs, depots, couriers, IRT providers).

• Develop and oversee clinical supply budgets, vendor quotes, proposals, and timelines.

• Drive cost optimization while ensuring quality and compliance are maintained.

• Confirm production plans and shipping schedules; develop resupply strategies for depots/sites and coordinate packaging schedules with third-party providers to accommodate clinical demand changes.

• Work with third-party providers to establish detailed project plans and timelines for 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 supervise the implementation of expiry date extensions.

• Coordinate the assessment of and monitor temperature excursions during storage, receipt, or transit to clinical sites or depots.

• Assist with the transportation and disposition of returned or unused materials as needed.

• Manage the activities required to source comparators and ancillary products, including planning supply strategies, labeling, and distribution activities.

• Contribute to the development of Standard Operating Procedures (SOPs) and guidelines related to third-party provider management, inventory management, distribution, transportation, and the disposition of returned or unused materials.

• Support the CMC team as required.

• Perform other duties as assigned.

⛳️ Requirements

• A minimum of a Bachelor’s degree in life sciences, nursing, business, or a related field, coupled with at least 12 years of relevant technical experience.

• Alternatively, a Master’s degree with 8 years of experience (an equivalent combination of experience and education may be considered).

• Prior experience in Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination.

• Experience in rare diseases or oral solid dosage forms is a plus.

• Knowledge of import and export management of drug substances and drug products.

• Understanding of CGMP and CGCP requirements, compendia testing, and ICH as well as regulatory guidelines, including stability data requirements.

• Exceptional interpersonal and communication skills (both written and verbal).

• Experience in preparing regulatory documents is preferred.

• Strong ability to work in a goal-oriented team environment while managing competing priorities.

• Ability to adapt to a rapidly changing environment with high attention to detail.

• Well-developed organizational skills and the capacity to perform well under pressure.

• Knowledgeable about industry trends, emerging business processes, and technologies.

🏝️ Benefits

• Discretionary annual target bonus.

• Stock options.

• Employee Stock Purchase Plan (ESPP).

• 401(k) match.

• Comprehensive health insurance plans for employees (and their families) that include medical, dental, vision, and basic life insurance.

• 20 days of paid time off (PTO).

• 10 paid holidays.

• Winter company shutdown.