Sr Manager, Supply Chain

职位描述

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 OR 6+ Years with MA/ MS or MBA OR

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