KEY RESPONSIBILITIES:

Sr. Manager, Global Clinical Supply Chain is a leader who carries out leadership vision and direction while providing expertise for Gilead's global clinical trials. Works collaboratively within the department and with cross-functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDM Product Strategy teams, GSC, etc.) to develop strategies, meet project deliverables, and solve business problems. This position has end-to-end leadership and accountability for clinical secondary packaging and labeling activities supporting investigational medicinal products (IMP) across multiple studies and programs. This role manages complexity, assesses risks, drives decisions, and prioritizes executable work plans to ensure on-time, in-full, and compliant delivery of packaged and labeled investigational medicinal products for global clinical studies.

The role may have people leadership accountabilities, including recruiting, onboarding, developing, retaining, and managing staff.

Has mature working knowledge of clinical secondary packaging and labeling operations and experience working within a GxP environment. Has strong cross-functional, multicultural awareness and communication skills in a fast-paced, global company. Demonstrates the ability to influence across functions, navigate ambiguity, and lead through operational complexity.

FOCUS AREAS:

• Interprets clinical study protocols and/or dosing schema and translates the information into secondary packaging and labeling requirements, including packaging configurations, label text requirements, and country- or study-specific needs.

• Develops and executes packaging and labeling strategies and plans in alignment with study timelines, IMP requirements, and overall clinical supply objectives.

• Partners closely with Clinical Supply Planning, Quality, Regulatory, internal labeling sites, and external partners to ensure packaging and labeling execution plans enable timely and compliant global delivery of IMP.

• Leads secondary packaging and labeling activities to support study start-up, enrollment changes, protocol amendments, resupply, and ongoing trial execution, while balancing competing priorities across programs.

• Supports quote reviews related to packaging and labeling activities, as well as purchase order and invoice reconciliations, as applicable.

• Oversees secondary packaging and labeling activities at internal and external sites to ensure compliant, high-quality, and timely execution.

• Ensures label content, booklet labels, randomization-related labeling requirements, and packaging designs are aligned with protocol, regulatory, and operational requirements.

• Identifies, reports, and escalates clinical supply incidents and issues related to packaging and labeling, and investigates root cause, as appropriate.

• Performs tasks in Gilead systems (e.g., SAP, IQS, GPLM, QMS, etc.) to enable compliant and efficient progression of IMP through packaging and labeling operations.

• Manages relationships with internal and external packaging and labeling sites to ensure services, timelines, quality, and deliverables meet study and business requirements. Monitors vendor performance, resolves issues, and partners cross-functionally to drive effective execution and continuous improvement.

• Leads business and process improvement initiatives, as applicable, to enhance operational efficiency, drive sustainable process improvements, and strengthen execution across packaging and labeling activities.

• Authors SOPs and business process work instructions as directed and supported by leadership.

• Supports regulatory filings and inspections related to packaging and labeling activities.

• Maintains compliance of clinical supply deliverables for trial master file (TMF).

• Maintains compliance with required training.

• May provide leadership, coaching, and day-to-day guidance to less experienced staff and contribute to building team capability and continuity.

BASIC QUALIFICATIONS:

• Bachelor’s degree with 8+ years of industry experience

OR

• Master’s degree with 6+ years of experience

OR

• PhD or PharmD degree with 2+ years of experience.

PREFERRED QUALIFICATIONS:

• Bachelor’s degree with 8+ years of industry experience

OR

• Master’s degree with 6+ years of experience

• Must have experience in clinical secondary packaging and labeling operations and working within a GxP environment.

• Degrees in the sciences preferred.

• Strong working knowledge of clinical secondary packaging and labeling operations including, but not limited to, packaging execution, label development and coordination, and operational planning.

• Strong working knowledge of clinical study designs, blinding practices, and global trials, from Phase 1 first-in-human to late phase.

• Strong working knowledge of GxP requirements and compliance considerations related to clinical secondary packaging and labeling.

• Ability to collaborate, influence, and negotiate effectively with cross-functional teams and external suppliers to meet clinical study timelines and patient needs.

• Demonstrated ability to apply sound judgment, manage ambiguity, and assess trade-offs in a complex clinical development environment.

• Excellent verbal, written, and interpersonal communication skills. Ability to write clear and concise documents and presentations.

• Strategic, enterprise thinking with the ability to connect complex operational business needs to practical process solutions.

• Ability to manage cross-functional resources and timelines for complex clinical studies, programs, initiatives, or projects. Project management experience preferred.

The salary range for this position is:

Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.