Senior Director, Global Clinical Supply Chain

Senior Director, Global Clinical Supply Chain United States - New Jersey - Parsippany, United States - California - Foster City Manufacturing Operations & Supply Chain Regular

Job Description

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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. 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.

Senior Director, Global Clinical Supply Chain

Senior Director, Global Clinical Supply Chain is an end-to-end clinical supply planning leader that provides relevant expertise in a fast-paced biopharmaceutical environment. The Senior Director works internally with other members of Global Supply Chain (GSC) and other Gilead functions – e.g., Clinical Development, Clinical Operations, Product Development & Manufacturing (PDM), Quality Assurance, Regulatory, and Project Management Office - to develop and formulate supply chain strategies, meet project deliverables, solve business problems and create competitive advantage. This position includes all elements of the clinical supply planning from the protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide. This leader will have expert working knowledge of clinical supply chain best practices and experience working with a GxP environment. The Senior Director, Global Clinical Supply Chain also has strong cross-functional and multi-cultural awareness as well as exceptional communication skills to lead in a fast-paced, global company.

Focus Areas

Serves as the clinical supply lead on PDM sub-teams especially for complex development programs – e.g., late phase, acquisition, partnership/alliance, new modality, etc.).

Leads the development and execution of overall clinical supply strategy and management for clinical development program(s), including management of investigational medicinal product (IMP) for assigned global trials.

Often in a matrix environment, oversees and supports clinical study planners. Facilitates issue and risk identification, mitigation, resolution and communication.

Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.

Identifies, manages and mitigates supply risks at clinical development program level. Leads and drives visible, impactful process improvements, change business and organizational imperatives.

Authors, revises and reviews standard operating procedures (SOPs), work instructions and business policies.

Accountable for clinical supply budget of assigned clinical development program(s).

Reviews and approves statement of work, purchase orders and invoices.

Influences, at times drives, program allocations at partners, contract manufacturing organizations (CMOs).

The position may have people leadership accountabilities, which include and are not limited to:

Leads clinical planning function within an assigned therapeutic area (TA)

Sets priorities and creates clear work plans for direct reports. Provides regular and timely communications as well as progress updates.

Develops direct reports. Recruits, onboards, develops and retains staff while contributing to department succession planning.

Sets clear goals and delivers consistently. Contributes to setting and rollout of department goals. Continuous improvement, operational excellence mindset.

Recognizes gaps in internal policies and procedures to new pending regulations. Mobilizes team to develop plans to close gaps. Influences cross functionally to implement industry best practice and identifies opportunities for process improvement.

Basic Qualifications

PhD or PharmD and 12+ years of supply chain management experience OR

Master’s and 12+ years of supply chain management experience OR

Bachelor’s and 14+ years of supply chain management experience

Preferred Qualifications

Requires a bachelor’s degree and highly preferable in a science-related field; MS, PharmD, or MBA desirable.

Prior experience in complex, oncology trials is highly preferred.

Expertise in clinical supply 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

Proven strong and effective collaboration, influencing and negotiation skills to work successfully with internal cross-functional group and external suppliers to meet the aggressive clinical study timeline and patient needs. Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.

Possesses experience with clinical blinding practices in global study, from Phase 1 to Late Phase.

Possesses expert experience in sourcing and managing comparator drugs and other co-meds for clinical studies, and, in comparator sourcing strategy.

Expert knowledge of the FDA GxP standards and regulatory guidance documents such as CFR, Annex 13, EU CTR. Able to support regulatory inquiries both face-to-face and with appropriate responses.

Expert in leading through ambiguity, can assess options quickly and efficiently implement the best option in alignment with Gilead's culture and expectations for clinical timelines.

Excellent verbal, written and interpersonal communication skills are required. Must have the ability to write clear, concise and error free documents/presentations. Must be a confident communicator and presenter to all organizational levels.

Strong computer, database and organizational skills required. ERP, Planning System, and Project management experience is a plus.

Ability to effectively manage resources and timelines for multiple teams with studies of different complexities. Ability to manage departmental and cross-functional projects.

Gilead Core Values

Integrity (Doing What’s Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)