Job Details

Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC)

Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC)

United States - New Jersey - Parsippany, United States - California - Foster City Manufacturing Operations & Supply Chain Regular

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 Gilead's 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 cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.

Focus Areas:

Oversees the collaboration with CSPM and other cross-functional 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 Gilead's 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 execution 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

Master's Degree and 10+ years of supply chain experience in the biotech/pharmaceutical industry OR

Bachelor's Degree and 12+ years of supply chain experience in the biotech/pharmaceutical industry

Preferred Qualifications:

Bachelor's degree in Supply Chain, Business, Science, or Engineering discipline. Master's 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 multi-disciplinary 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 cross-functional and multi-cultural teams.

Gilead Core Values

Integrity (Doing What's Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

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Job Requisition ID R0045026

Full Time/Part Time Full-Time

Job Level Director

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