Director Comparator Sourcing Global Clinical Supply Chain GCSC

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Job Description

The Director Comparator Sourcing Global Clinical Supply Chain GCSC) is responsible for providing leadership over the comparator sourcing strategy and timely delivery management. This Director Comparator Sourcing GCSC will effectively manage relationships with vendors and Procurement as needed and acts as the point escalation for the planning organization on issues for comparator provision. As a key contributing member of the GCSC Leadership Team (GCSC LT) you will ensure strategic alignment to Gileads development portfolio and strategic goals as well as build strong relationships with Gilead functional leadership (including and not limited to Clinical Supply Planning and Management (CSPM) Clinical Operation Regulatory Quality and the rest of PDM) to ensure alignment of the organizations and prompt resolution of critical issues. You are considered an expert with working knowledge of supply chain best practices and experience working with a GxP environment. The Director Comparator Sourcing GCSC has a strong crossfunctional multicultural awareness and communication skills to lead in a fastpaced global company.

Focus Areas:

• Oversees the collaboration with CSPM and other crossfunctional teams to understand the comparator requirements for clinical studies.

• Develops efficient effective and compliant sourcing strategies to deliver the comparators on time in full. The sourcing strategies are measured based on maximizing supply efficiency minimizing waste while identifying risks and developing as well as communicating risk mitigation plans.

• Partners with Procurement Quality and Regulatory for the identification qualification and management of comparator sourcing vendors in support of Gileads portfolio.

• Builds an infrastructure for the collection of comparator information ensuring resident expertise is established for types of comparators on the market including pack sizing.

• Ensures on time responses between the vendors Procurement and CSPM in support of delivery for the required comparators on time.

• Ensures support is provided to CSPM and other key stakeholders in providing supporting documentations for the comparators e.g. SmPC product specs etc.

• Ensures tracking of target of delivery to CMOs support release activities.

• Responsible for investigation of exceptions to determine root causes implement CAPAs and drive closure e.g. time of environment (TOE) temperature excursions etc.

• Responsible for informing and/or escalating market recalls withdrawals and safety alerts as related to sourced comparators.

• Builds strategic relationships with internal functional groups and ensures alignment.

• Participates or leads process improvement initiatives cross functionally with stakeholders contributing to global/regional initiatives or programs.

• Participates in CD&OP reviews presents comparator supply delivery performance and facilitates related discussions as required.

• Ensures robust systems and processes are in place to enable of operational and logistical tasks in a GxP compliant manner.

• Collaborates and authors department policies and procedures.

Basic Qualifications:

• Advanced scientific degree (i.e. PhD) and 8 years of supply chain experience in the biotech/pharmaceutical industry OR

• Masters Degree and 10 years of supply chain experience in the biotech/pharmaceutical industry OR

• Bachelors Degree and 12 years of supply chain experience in the biotech/pharmaceutical industry

Preferred Qualifications:

• Bachelors degree in Supply Chain Business Science or Engineering discipline. Masters degree and/or professional qualifications in Supply Chain Management desired.

• 12 years progressive experience in supply chain preferably within biotech pharmaceutical CRO industry with 5 years in comparator sourcing.

• Experience working in a global complex supply chain organization within the biopharma industry.

• Experience building and leading teams from multidisciplinary departments.

• Strong ability to collaborate and build strategic relationships with internal stakeholders Clinical Operations Quality Regulatory CMC etc.

• Demonstrates advanced knowledge of global clinical trials and the drug development process.

• Experience in vendor oversight and managing external partnerships and relations.

• Experience with comparator sourcing.

• Understanding of IRT system functionality and forecast modeling.

• Awareness of comprehensive global pharmaceutical regulatory requirements (e.g. cGMP ICH/GDP GCP 21 CFR Part 11 and EU CTR Annex VI etc..

• Experience in deviation investigation and CAPA implementation.

• Ability to work effectively in crossfunctional and multicultural teams.

Gilead Core Values

• Integrity (Doing Whats Right)

• Inclusion (Encouraging Diversity)

• Teamwork (Working Together)

• Excellence (Being Your Best)

• Accountability (Taking Personal Responsibility)

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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