Sr Manager, Supply Chain

Gilead Sciences • Foster City, CA

5d • $157,590 - $203,940

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Requirements

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

Nice To Haves

• Degrees in the sciences preferred.
• Project management experience preferred.

Responsibilities

• 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.
• Has end-to-end leadership and accountability for clinical secondary packaging and labeling activities supporting investigational medicinal products (IMP) across multiple studies and programs.
• 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.
• May have people leadership accountabilities, including recruiting, onboarding, developing, retaining, and managing staff.
• 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.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Manager