Senior Manager, Global Clinical Supply Chain

Senior Manager, Global Clinical 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.

Key Responsibilities

Senior Manager, Global Clinical Supply Chain is a leader that carries out leadership vision and directions 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, Information Technology, etc.) to develop strategies, meet project deliverables, and solve business problems. The position has end-to-end leadership and accountability for clinical supply management. Prioritizes and creates executable work plans to ensure on time in full, safe delivery of investigational medicinal products (IMP).

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

The role may have accountability for the strategy, implementation and management of digital tools and systems that support Global Clinical Supply Chain. The intent is to bridge gap between supply chain processes and information technology, ensuring the right digital or technology platform is in place to optimize clinical supply planning, inventory management and distribution.

Has mature working knowledge of supply chain and experience working with GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills in a fast-paced, global company

Focus Areas

Interprets clinical study protocols and / or dosing schema. Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management.

Performs demand and / or supply forecasting and planning with planning horizon of 9 to 18 months. Translate forecasts into clinical packaging and labeling (CPL) execution plans. Supports contract / quote reviews and purchase order and invoice reconciliations.

Develops and implements depot and clinical site seeding and resupply strategies.

Supports the clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinical supply strategies and plan with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.

Ensures accurate inventory and records at depots through timely reconciliation.

Keeps abreast of clinical supply incidents and issues. Reports and escalates issues as well as investigates root cause as appropriate.

Performs tasks in Gilead systems (e.g., SAP, IVRS, QMS, etc.) to enable compliant and efficient progression of IMP through the supply chain.

Authors SOPs and business process work instructions as per leadership direction and support.

Supports regulatory filings and inspections.

Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF).

Maintains compliance with required training.

Digital Systems

IVRS support : serves as the primary contact of interacting and collaborating with internal and external partners. These include and not limited to Clinical Vendor Outsourcing, Clinical Operations and IVRS vendors. Provides subject matter expertise for the design, development, configuration and user acceptance testing (UAT) as related to IMP management in accordance with clinical study protocol. Provides troubleshooting support for system issues as they arise.

Enterprise Resource Planning (ERP) support : serves as the business process owner or lead effectively representing GCSC in the design, development, configuration and implementation of system upgrades or cutover to new ERP system. Has good understanding and working knowledge in master data management.

Data and analytics : oversees the use of digital systems to gather, analyze and automate data visualization related GCSC. Uses data to enable department's optimization in demand and supply forecasting, inventory management and supply chain visibility. Must have growth and continuous improvement mindset to ideate and drive initiatives that leverage technologies to automate tasks, reduce human errors as well as increase efficiency and effectiveness of clinical supply chain.

Basic Qualifications

8+ Years with BS / BAOR

6+ Years with MS / MA or MBA

Preferred 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.

Degrees in the sciences preferred.

Strong working knowledge in clinical supply management including and not limited to forecasting, demand / supply planning, IVRS and ERP systems.

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

Strong working knowledge of Clinical Demand and Operations Planning (CD&OP).

Experience with managing comparator drugs and other co-meds for clinical studies.

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

Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functional expectations.

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

Strategic, enterprise thinking with ability to distill complex business problems to technology solutions.

Strong or excellent computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systems and databases used at Gilead.

Ability to manage the cross functional resources and timelines for complex clinical study and programs or initiatives / projects. Project management experience preferred.

People leader accountabilities

Create inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

Develop talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

Empower teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

The salary range for this position is :

Bay Area : $157,590.00 - $203,940.00.

Other US Locations : $143,225.00 - $185,350.00.

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