Sr. Associate, Supply Chain - Clinical Supplies
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossibleFor Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.Job Description
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases. The Senior Associate of Clinical Supply is an enthusiastic individual who works collaboratively with their manager, the Clinical Supply Chain Management (CSCM) team, and the Clinical Operations team to carry out operational activities of the clinical supply chain including protocol design, manufacturing, distribution and inventory management of clinical supplies.Responsibilities include:
Knowledge and Skills:
- Manages supplies for clinical studies.
- Reports quality-related issues with labels/labeling/distribution vendors in a timely manner for resolution.
- Works as part of a team with other members of CSCM to ensure on-time delivery of investigational medicinal product (IMP) to initial and resupply clinical trials.
- Collaborate with external partners and the Logistics team to complete stand-alone and/or project-related tasks to meet clinical study timelines.
- Track regulatory updates related to studies (e.g. country-level approval, filing status, labelling approvals); report challenges to leadership; support regulatory inspections; prepare Clinical Study Report; keep Trial Master File up to date.
- Obtain and review quotes along with approving purchase requisitions and invoices.
Education and Experience:
- Basic knowledge of supply chain principles including GMP regulations.
- Developing collaboration, influencing, and negotiation skills to work effectively with internal cross-functional groups and external suppliers to meet the aggressive clinical study timeline and patient needs.
- Knowledge of clinical blinding practices in global studies, from Phase 1 to Late Phase.
- Developing knowledge of comparator sourcing.
- Developing regulatory knowledge of the FDA, cGMP, and GCP standards.
- Learning to work with ambiguity with the manager's support within Gilead's culture and expectations
- Strong verbal, written, and interpersonal communication skills are required.
- Strong computer, database, and organizational skills required.
- 2+ years of relevant experience and a Bachelor's degree
- 0+ years of relevant experience and a Master's degree
- Degrees in the sciences preferred
We offer you the opportunity to work within a culture of highly motivated, talented individuals who are dedicated to the company's mission. Each job provides wide-ranging responsibilities due to our cross-functional organizational structure and leadership style, which ensures that everyone is engaged, committed and accountable. We are looking for individuals from diverse backgrounds who want to work together and support each other to help make a real difference in the lives of patients - people who thrive on performing well within a challenging and fast-paced environment, living our core values of Integrity (always doing the right thing), Teamwork (collaborating in good faith), Excellence (working at a high level of commitment and capability), Accountability (taking personal responsibility) and Inclusion (Encouraging D
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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 firstname.lastname@example.org
for assistance.Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
For more information about equal employment opportunity protections, please view the 'EEO is the Law'
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For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site
to apply for this job.