- 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.
- 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.
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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Director, Comparator Sourcing, Global Clinical Supply Chain - Foster City, United States - Gilead Sciences, Inc.
Description
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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.
We empower our leaders to step up, share ideas, listen, learn, and lead.We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged.
We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
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.
Join Gilead and help create possible, together.Job Description
Gilead Sciences, Inc.
is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.
The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer.
Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.Director, Comparator Sourcing, Global Clinical Supply Chain (GCSC)
KEY RESPONSIBILITIES:
Director, Comparator Sourcing, GCSC is responsible for providing leadership over the comparator sourcing strategy and timely delivery management.
Effectively manages relationships with vendors and Procurement as needed and acts as point escalation for the planning organization on issues for comparator provision.
A key contributing member of the GCSC Leadership Team (GCSC LT) and ensures strategic alignment to Gilead's development portfolio and strategic goals.
Builds 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.
Has an expert working knowledge of supply chain best practices and experience working with a GxP environment. Has strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.FOCUS AREA:
QUALIFICATIONS:
The salary range for this position is: $205, $266, Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
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*.For additional benefits information, visit:
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce.
Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws.
In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.NOTICE:
EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
