Executive Director, Global Clinical Supply Chain (GCSC)

Gilead Sciences•Parsippany, NJ

48d

About The Position

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. The Executive Director, Global Clinical Supply Chain (GCSC) is responsible for leading the clinical planning function within an assigned therapeutic area (TA). This role is an end-to-end leadership position that inspires and motivates teams while guiding the overall strategy supporting the GCSC function. The incumbent provides subject matter expertise on a diverse portfolio of development programs and different therapeutic modalities, including small molecules, biologics, and cell gene therapy for Gilead’s global clinical trials. The Executive Director collaborates internally with members of GCSC and other functions, including but not limited to Development Operations, Clinical Operations, and Process Development and Manufacturing (PDM), to develop strategies, meet project deliverables, solve business problems, and create competitive advantage. This position encompasses the end-to-end elements of clinical planning and execution, from protocol design through manufacturing to the ultimate distribution and inventory management of clinical supplies at clinical sites worldwide.

Requirements

16+ Years of relevant industry experience with BA/BS. OR 14+ Years with MA/MS or MBA PHD or PharmD.
Expert working knowledge of clinical supply chain best practices.
Experience working with a GxP environment.
Strong cross-functional, multi-cultural awareness and communication skills to lead in a fast-paced, global company.
Demonstrated hands-on end-to-end clinical supply knowledge and experience with clinical trials in the therapeutic area of oncology while maintaining elevated, strategic oversight at the portfolio level.

Nice To Haves

Degree in a science-related field; MS, PharmD, or MBA desirable.
Strong 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.
Prior experience in complex Oncology trials is highly-preferred.
Proven strong and effective collaboration, influencing, and negotiation skills to work successfully with internal cross-functional groups and external suppliers to meet aggressive clinical study timelines and patient needs.
Demonstrated ability to collaborate and build strategic relationships with internal and external stakeholders.
Possesses experience with clinical blinding practices in global studies, 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 lead or manage TA, department-level, and cross-functional projects.

Responsibilities

Establishes strategies to ensure uninterrupted clinical supply for the overall development portfolio, including clinical development programs and studies at all phases, as well as managed access programs.
May lead large complex projects within the department and represent GCSC in cross-functional projects.
Leads, develops, and manages the team, which includes recruitment, onboarding, and succession planning.
Drives excellence and is accountable for setting clear goals and consistently delivering.
Accountable for setting team goals in alignment with department and enterprise goals.
Responsible for developing and maintaining a culture of continuous improvement.
Mobilizes teams to develop plans, works cross-functionally within PDM and at the enterprise level to identify and implement best practices.
Performs sponsor roles as requested.
Champions clinical demand and operation planning (CD&OP), interfacing with leaders from Clinical Operations and PDM sub-teams.
Manages across enterprise functions and partners to ensure on-time, in-full delivery of investigational medicinal product (IMP).
Ensures efficient and robust resource allocation for PDM sub-teams and clinical study teams.
Partners across several PDM functions and with other enterprise functions to ensure the on-time, in-full (OTIF) delivery of IMP to initiate and resupply clinical studies.
Responsible for decision-making and directing the long-term vision of optimal supply chain strategies, including labeling and distribution activities.
Responsible for risk balancing by allocating work.
Identifies and champions areas where process improvements are imperative.
Drives resolution of complex issues, through partner sponsors as needed.
Responsible for planning SOPs, Work Instructions, business policies, and procedures to ensure GxP compliance.
Influences cross-functional SOP content and reviews/approves as required.
Oversees and supports clinical study planners.
Facilitates issue and risk identification, mitigation, resolution, and communication.
Serves as the PDM sub-team for RFD assets, leads supply management for first-in-human (FIH) clinical trials.
Drives decision-making at cross-functional teams (ClinOps, PDM sub-teams) supporting the long-term vision.
Responsible for the departmental budgeting process – forecasts clinical supply spends, estimates headcount requirements, as well as department-related expenses (contractors, consultants, recruitment, project expenses, etc.).
Leads TA-level allocations decisions and influences and negotiates partner performance.