Job Title: Senior Director, Clinical Trial Supplies

Location: San Diego or Remote U.S.

Job Type: Full-Time

Position Summary

Reporting to the Senior Vice President, Clinical Operations, the Senior Director, Clinical Trial Supplies will provide strategic and operational leadership for global clinical trial supply management across Phase I-Phase III of development. This role is responsible for the end-to-end planning and execution of clinical supply continuity, including forecasting, inventory management, global distribution and reverse logistics, ensuring uninterrupted supply in compliance with regulatory requirements. The position serves as the primary point of contact for clinical supply strategy across internal teams and external vendors/partners.

Essential Job Functions and Responsibilities

• Develop and execute global clinical supply strategies Ph I - III, including demand forecasting
• and inventory optimization
• Lead end-to-end clinical supply operations, including distribution, depot management, site supply and reverse logistics
• Oversee vendor selection, contracting, onboarding, qualification, and ongoing operational management of external logistics partners, specialty couriers, and service providers
• Manage vendor identification, selection, and contracting, in partnership with internal teams for (e.g., Master Service Agreements, Work Orders, and Change Orders)
• Serve as the operational owner for day-to-day patient-specific shipment coordination, aligning constraints and QA release
• Monitor supply chain performance in real-time, resolving risks such as delays, deviations, or temperature excursions
• Establish efficient processes for inventory management and evaluate drug utilization versus forecast to continually enhance optimal execution of Clinical Supply strategy
• Lead the development, authorship, and lifecycle management of Management, and Pharmacy Manuals
• Establish and maintain SOPs, work instructions, and clinical supply documents
• Collaborate cross-functionally on clinical protocols, packaging, labeling, and supply-related documentation
• Manage clinical supply budgets, forecasting, and financial tracking, reconciliation
• Define and track clinical supplies KPIs, metrics, and operational performance to support decision-making and continuous improvement
• Identify, select, and manage IRT vendors
• Serve as subject matter expert (SME) during all inspections and clinical supply audits
• Serve as clinical supplies key point of contact for collaborations and partnerships
• Identify risks to clinical programs and develop improvement plans for clinical supply GMP

Preferred Qualifications

• Bachelor's degree required, advanced medical or life sciences or a related area degree preferred (e.g., MS, PhD) with 12+ years of experience in the life sciences industry or an equivalent combination of academic and industry experience
• 8+ years of team leadership experience, with a proven track record of building effective teams and driving innovation in clinical trial optimization
• Extensive experience managing clinical supply chains and working CMOs in a cGMP environment
• Strong knowledge of drug development, ICH-GCP, and applicable regulatory requirements (including 21 CRF Part 11)
• Ability to influence and lead others in preparing for audits and inspections by identifying potential areas of risk and developing risk mitigation strategies
• Willingness and capability to work effectively in a smaller biotech company (i.e., willing to roll-up your sleeves as necessary to help get the job done)
• Proven ability to handle a high volume of complex tasks within a given timeline
• Self-motivated, independent and results-oriented
• Excellent organizational and problem-solving skills with the capacity to organize assignments, work within multiple deadlines, and change priorities
• Exceptional attention to detail
• International clinical supply experience preferred
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
• Strong analytical and problem-solving abilities, with a strategic mindset
• This position requires periodic/regular travel, including up to 10% of work time, which may include overnight travel

Physical Demands and Work Environment

Physical Demands:

• Constant or continuous use of a computer keyboard, monitor, and mouse to perform a variety of tasks
• Constant or frequent sitting, standing, or walking
• May lift and/or move objects of various weights

Work Environment:

• Remote: Home office; expected to travel to and work from the Company's headquarters in San Diego from time to time
• San Diego-based: On-site requirement (Monday through Thursday)
• Noise level in the work environment is usually moderate
• Fast-paced, time sensitive environment with frequently changing priorities
• Handle multiple projects simultaneously

Reasonable accommodations may be provided to enable qualified individuals with disabilities to perform the essential functions of the position.

Salary Range

The salary range for this position is $265,000 to $275,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include, but are not limited to, the type and years of experience within the job and the industry, education, and skills and certifications.

Benefits

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life and AD&D insurance. Additional benefit programs include short-term and long-term disability insurance, flexible spending accounts, health savings accounts, and voluntary insurance programs, including voluntary life, AD&D accident, and critical illness. Employees will also be able to enroll in the Company's 401(k) plan. In addition, employees will accrue 10 hours of paid vacation time every month and accrue 1 hour of paid sick leave for every 30 hours worked. Employees also enjoy 17 paid holidays each calendar year, including a winter closure, subject to applicable Company policies. All benefits are subject to the terms and conditions of the applicable plan documents and Company policies, which may be amended from time to time.

Other Compensation

The hired candidate will be eligible to receive an annual discretionary bonus and an equity award, subject to the terms of the applicable employment agreement, plan documents, and Company policies.

The information above is intended to provide a general description of benefits and other compensation and is not a substitute for applicable plan documents or company policies.

Applications for this position are anticipated to close on July 31, 2026. For more information about this posting, please contact [email protected].