Sr Director, Supply Chain

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Job Description

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.
Has an expert working knowledge of clinical supply chain best practices and experience working with a GxP environment. Has strong cross-functional multi-cultural awareness and communication skills to lead in a fast-paced global company.

FOCUS AREA:

Serves as the supply chain lead on PDM product strategy 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).

Lead or a contributing member to GCSC GSC or PDM strategic initiatives including and not limited to due diligence resource pool global drug delivery community clinical supply integration due to M&A and policy topic member supporting the External Advocacy Steering Team (EAST).

Knowledge:

• Able to develop complex concepts techniques and standards.

• Able to develop solutions to complex problems which require an in depth degree of ingenuity creativity and innovativeness.

• Challenges are frequently unique and solutions may serve as precedent for future decisions which affect the entire organization.

• Recommends organizational objectives and interprets company policies. Must have in-depth expertise in EU and international cGMPs.

• Able to interpret execute and recommend modifications to department policies.

• Demonstrates effective communication skills and the ability to deal across several multi-national agencies sites and organizations.

Minimum Education & Experience Requirements:

• 14 years of relevant experience in related field and a BS or BA; OR 12 years of relevant experience and a MA/MBA OR 8 Years with PhD or PharmD.

• Requires a bachelors degree and highly preferable in a science-related field; MS PharmD or MBA desirable.

• Prior experience in complex oncology trials is highly-preferred.

• 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

• 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 Gileads 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.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

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