Job Description

Assoc Director, Supply Chain

United States - California - Foster City Process/Product Development & Operations Regular

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Associate Director, Global Clinical Supply Chain is a leader who 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 sub-teams, GSC, 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.

Focus Areas:

Supports the development of supply strategy while working collaboratively to oversee supplies for clinical developmental portfolio and ensure on time delivery of investigational medicinal product (IMP) to initiate and resupply clinical studies (e.g., GCSC Rep in PDM team);

Influence decision-making at cross-functional teams (Clin Ops, PDM teams); GCSC rep for typically (1+) developmental programs- able to take on programs of greater complexity.

Collaborate other GCSC, PDM leaders and external vendors & partners to resolve shipping relate issues and implement long term solutions/changes.

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 to required training.

Specific Job Responsibilities:

Works on problems of moderate to advanced complexity where analysis of situations or data requires an evaluation of intangible variables.

Provides leadership, direction and management of a team, to support execution of the Supply Chain strategy.

Provides supervision, training, guidance and performance management to department personnel.

Creates and maintains a positive working environment to ensure high productivity, employee engagement and performance.

Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.

Develops and implements policies and procedures for the operation of Supply Chain activities, ensuring all relevant regulatory requirements are met.

Develops and implements strategies and goals for specific products or projects.

Creates and effectively communicates supplier, subcontractor and/or vendor agreements and opportunities to the organization.

Implements and maintains material and production control systems, policies, processes and procedures ensuring that a controlled flow of approved materials timed to meet production requirements.

May serve as liaison between the company and the various governmental agencies and/or audit agencies as required.

Reviews, and/or implements changes to controlled documents as needed. May author sections of regulatory documents.

Negotiates large contracts involving substantial financial amounts. Monitors cost, schedules and performance aspects of major contracts. Drives cost savings through direct negotiation and other sourcing methods.

May execute supplier agreements in conjunction with Legal and internal clients to ensure contracts terms and conditions are in compliance with corporate and purchasing guidelines.

Conducts formal business reviews with key suppliers, subcontractors and/or vendors to discuss performance on a regular basis. Manages against contract performance to ensure that agreed upon cost, service, quality, schedule and flexibility goals are met.

May manage outsourced manufacturing activities.

Compiles information from periodicals, catalogs, and other sources to keep informed on relevant market and competitor information.

May be responsible for coordinating multiple production schedules.

Knowledge and Key Skills:

Able to develop solutions to a wide range of complex problems, which require the regular use of ingenuity and innovation.

Exceptional verbal and written communication skills. Able to create written communication that is properly structured providing clear, concise messages that draw well supported conclusions.

Good organizational and time management skills, including working knowledge of basic project management tools and techniques.

Ability to interact effectively with senior management.

In depth understanding and application of relevant principles, concepts, practices, and standards, along with an in-depth knowledge of industry practices.

Solid working knowledge of relevant regulatory guidance, including pharmaceutical GMPs and ICH Q7A.

Able to apply established organizational policies, and interpret, execute, and recommend modifications to department policies and procedures as needed.

May require familiarity with the technologies, strengths, and weaknesses of a wide variety of fine chemical and pharmaceutical manufacturers worldwide.

Demonstrates an in-depth understanding of the financial aspects of Supply Chain operations.

Demonstrates in-depth knowledge and proficiency across multiple practices within Supply Chain department, to understand, coordinate and communicate across the competing demands of each.

Specific Education & Experience Requirements:

10+ years relevant experience in related field and a BS or BA; OR 8+ years of relevant experience and a MA/MBA.

Experience in pharmaceutical operations/cGMP environment highly desirable.

Experience in pharmaceutical operations/cGMP environment highly desirable.

May require experience purchasing custom chemicals, planning pharmaceutical development activities, and managing the third-party synthesis of intermediates/Active Pharmaceutical Ingredients

Job Description

At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gileads 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 were 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

Associate Director, Global Clinical Supply Chain is a leader who carries out leadership vision and directions while pr]]> <

Job Tags

Full time, Contract work, For subcontractor, Worldwide,

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