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.
Job Description
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.
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: $157,590.00 - $203,940.00. 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.
For jobs in the United States:
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' (https://www.eeoc.gov/employers/eeo-law-poster) poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT (http://www.dol.gov/whd/regs/compliance/posters/eppac.pdf)
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
