Sr Manager, Supply Chain

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.

The Sr. Clinical Supply Manager is a leader that inspires teams while providing expertise for Gilead's global clinical trials. They work collaboratively with Clinical Supply Chain Management team, Pharmaceutical Development and Manufacturing Teams to develop strategies, meet project deliverables, solve business problems. The position includes all elements of the clinical supply chain from the protocol design through manufacturing to distribution and inventory management of clinical supplies at clinical sites globally.

Specific Job Requirements:

· Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3 and Late Phase).

· Leads end –to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).

· Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).

· Collaborate with Logistics management and other members of CSCM, PDM, and external partners to resolve shipping related issues; Escalates to senior leadership as needed

· Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence

· Keeps abreast of all incidents related to shipment and reports trending to Quality Assurance and supports the resolution of CAPAs

· Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.

· Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement

· Shapes the future of the clinical supply chain management department by participating in recruitment, training, performance management and staff development.

· Provides clear vision and direction to the staff while actively mentoring them in their growth and development. Listens to staff concerns and develops action plans to meet long-term objectives.

· Engages the clinical supply chain management team to meet company goal