Gilead Sciences, Inc. Sr. Manager, Clinical Supplies in Foster City, California

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description

The Senior Clinical Supplies Manager is an Enthusiastic leader that inspires teams while providing expertise in a fast paced pharmaceutical clinical supplies environment for Gilead’s global clinical trials. The Sr. Manager, Clinical Supplies works collaboratively with other members of Clinical Supply Chain Management, Pharmaceutical Development and Manufacturing and Development Operations staff to meet project deliverables, solve business problems and create competitive advantage. This role has great exposure to all elements of the clinical supply chain from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at the clinical sites worldwide. Gilead is committed to bringing life-saving drugs to patients in need via small molecules, biologics and cell therapy. Gilead offers a tremendous environment for growth and staff in CSCM have opportunities to work on projects from a wide range of therapeutic areas including Oncology, Liver Disease, HIV, Respiratory and others.

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).

  • 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

  • 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.

  • Authors and reviews SOPs and labeling batch records required for distribution and clinical labeling activities to ensure GMP compliance.

  • Prepares and/or approves purchase orders and supports the budgeting process.

  • Examines functional issues from a broader organization perspective.

  • Can lead two or more specific components of departmental strategic initiatives.

Knowledge:

  • Excellent verbal, written, and interpersonal communication skills are required.

  • Strong computer and organizational skills required. Project management experiences a plus.

  • Must be able to anticipate client obstacles and difficulties and act upon this in order to meet goals.

  • Must have the ability to write clear, concise and error-free documents.

  • Must be able to exercise judgment within defined procedures and policies in order to determine and take appropriate action.

  • Must possess a strong knowledge of the FDA, cGMP, and GCP standards as well as regulatory guidance documents such as Annex 13.

  • Possesses clinical supplies experience/knowledge in forecasting, demand / supply planning, IRT systems, inventory management, clinical labeling and distribution including cold chain, import/export and reverse logistics.

  • Possesses strong 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.

  • Works well with ambiguity, can assess options quickly and efficiently and implement 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 of relevant industry experience (preferably in end to end clinical supply management including clinical labeling)

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) and Accountability (taking personal responsibility).

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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 careers@gilead.com for assistance.

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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.

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercialises 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.

If this is not the right move for you now but remain interested in a career at Gilead Sciences please connect with us via our talent community at http://gilead.avature.net/Gilead