Skip to main content

This job has expired

You will need to login before you can apply for a job.

Sr. Clinical Supply Manager

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Dec 4, 2021

View more

Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

Sr. Clinical Supply Manager
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 #CreatingPossible


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 Sr. Clinical Supply Manager is a leader that inspires teams while providing expertise for Gilead's global clinical trials. They work collaboratively with Clinical Supply Chain Management team, Pharmaceutical Development and Manufacturing Teams to develop strategies, meet project deliverables, solve business problems. The position includes all elements of the clinical supply chain from the protocol design through manufacturing to distribution and inventory management of clinical supplies at clinical sites globally.

Specific Job Requirements:
  • Responsible for managing supplies for dynamic clinical studies associated with multiple clinical development programs across the lifecycle of the programs (Phase 1, 2, 3 and Late Phase).
  • Leads end -to-end clinical supply responsibilities including but not limited to protocol interpretation, demand planning, supply planning, distribution, inventory management, label generation and planning and execution of labeling operations at partner contract manufacturing organizations (CMOs).
  • Works collaboratively with Clinical Operations, Formulation Process Development, Device Development and Clinical Package Engineering, Quality Assurance, Regulatory, Outsourced Manufacturing and Project Management partners to develop optimal supply strategies and ensure on time delivery of clinical supplies to initiate and resupply studies with investigational medicinal product (IMP).
  • Collaborate with Logistics management and other members of CSCM, PDM, and external partners to resolve shipping related issues; Escalates to senior leadership as needed
  • Partners with Quality Assurance to resolve quality-related issues with labels/labeling/distribution vendors in a timely manner and develops holistic corrective actions to prevent recurrence
  • Keeps abreast of all incidents related to shipment and reports trending to Quality Assurance and supports the resolution of CAPAs
  • Partner with Regulatory to ensure labels meet global regulatory requirements and filings accurately reflect the global supply chains.
  • Oversees labeling/distribution contractor activities and relationships and participates in vendor selection, onboarding, management, issue resolution and continuous improvement
  • Shapes the future of the clinical supply chain management department by participating in recruitment, training, performance management and staff development.
  • Provides clear vision and direction to the staff while actively mentoring them in their growth and development. Listens to staff concerns and develops action plans to meet long-term objectives.
  • Engages the clinical supply chain management team to meet company goals including providing clinical supplies, developing organizational capabilities and continuously improving processes and systems.
  • Stays current with industry trends and best practices with respect to clinical supply management as well as changes in the regulatory landscape that would impact clinical supply chain.
  • Revise and author SOPs and Work instructions with manager direction and support
  • Obtain and review quotes, approves purchase requisitions and invoices.
  • Examines functional issues from a broader organization perspective.
  • Can lead two or more specific components of departmental strategic initiatives.
  • Responsible for maintaining GDP, GMP, and global trade compliance
  • Implement and carry-out vision and direction
  • Ensures priorities are being met and creates clear work plans for staff; communicates progress regularly
  • Typically recruits, onboards, develops, retains, and supervises staff; sets clear goals for individuals


Knowledge:
  • Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations.
  • Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.
  • Be able to manage the resources and timelines for programs of high complexity
  • Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.
  • Possesses solid experience in managing comparator drugs and other co-meds for clinical studies
  • Mature knowledge of the FDA, cGMP, GCP standards and regulatory guidance documents such as CFR, Annex 13.
  • Possess strong clinical supplies management experience/ knowledge in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution including cold chain, import/export, reverse logistics, CMC and GXP regulations
  • Possesses strong collaboration, influencing and negotiation skills to work effectively with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs.
  • Leads through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines


Specific Education and Experience Requirements:

Requires a Bachelor's degree preferably in a science-related field

8+ Years with BA/ BS 6+ Years with MA/ MS or MBA

2+ Years with PHD or PharmD

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

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 careers@gilead.com 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. 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' 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.




jeid-e9e763b4fa834042b25309d92f0cf7a7

Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert