Gilead Sciences, Inc.
Overview
Sr Director, Global Clinical Supply Chain – United States, New Jersey – Parsippany. Regular status. Gilead is focused on developing therapies to address HIV, viral hepatitis, COVID-19 and cancer, with a mission to improve lives and ensure global access. We seek a senior supply chain leader who will drive end-to-end clinical supply planning in a fast-paced biopharmaceutical environment and collaborate across Global Supply Chain (GSC) and other Gilead functions. We value leaders who foster an inclusive culture, empower employees, and drive performance in a collaborative environment. Responsibilities
Provide end-to-end clinical supply planning leadership from protocol design through manufacturing to distribution and inventory management of clinical supplies at sites worldwide.
Lead development and execution of overall clinical supply strategy for clinical development programs, including management of investigational medicinal product (IMP) for global trials.
Oversee and support clinical study planners in a matrix environment; facilitate issue and risk identification, mitigation, resolution and communication.
Drive cross-functional decision-making with ClinOps, PDM sub-teams and other functions to support long-term vision.
Identify, manage and mitigate supply risks at the program level and drive process improvements and organizational initiatives.
Author, revise and review SOPs, work instructions and business policies; maintain accountability for clinical supply budgets and approvals of SOWs, POs and invoices.
Influence or lead program allocations with partners and CMOs; participate in strategic initiatives within GCSC, GSC or PDM.
Knowledge and Skills
Ability to develop complex concepts, techniques, and standards; solutions to complex problems with ingenuity and innovation; experience in EU and international cGMPs.
Effective cross-cultural communication and collaboration across multinational agencies, sites and organizations.
Strong regulatory acumen with knowledge of FDA GxP standards and regulatory guidance (e.g., CFR, Annex 13, EU CTR); ability to support inquiries.
Excellent written and verbal communication; ability to write clear, concise, error-free documents and present to all levels.
Strong computer, database and organizational skills; ERP, planning systems and project management experience preferred.
Ability to manage resources and timelines for multiple studies with varying complexity; manage departmental and cross-functional projects.
Minimum Education & Experience
14+ years of relevant experience with a BS/BA; OR 12+ years with MA/MBA; OR 8+ years with PhD or PharmD.
Academic preference for science-related fields; MS, PharmD or MBA desirable.
Prior experience in complex oncology trials is highly preferred.
Experience in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution (including cold chain), import/export, reverse logistics, CMC and GXP regulations.
Strong collaboration, influencing and negotiation skills with internal and external stakeholders; ability to meet aggressive timelines.
Experience with clinical blinding practices in global studies (Phase 1 to late phase).
Experience sourcing and managing comparator drugs and co-medications for clinical studies; comparator sourcing strategy.
Expert knowledge of FDA GxP standards and regulatory guidance; ability to support regulatory inquiries.
Ability to lead through ambiguity and align options with Gilead culture and timelines.
Proficient in written and oral communication; ability to present to all levels.
Strong computer, database and organizational skills; ERP/planning systems experience a plus.
Ability to manage resources and timelines for multiple teams and studies with varying complexity.
Compensation and Benefits
The salary range for this position is: $221,000.00 - $286,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision and life insurance plans. For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to terms and conditions of applicable plans. Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants, fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or other protected characteristics. Reasonable accommodation requests can be made to ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Current Gilead Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047665 Full Time/Part Time: Full-Time Job Level: Director Click below to return to the Gilead Careers site
#J-18808-Ljbffr
Sr Director, Global Clinical Supply Chain – United States, New Jersey – Parsippany. Regular status. Gilead is focused on developing therapies to address HIV, viral hepatitis, COVID-19 and cancer, with a mission to improve lives and ensure global access. We seek a senior supply chain leader who will drive end-to-end clinical supply planning in a fast-paced biopharmaceutical environment and collaborate across Global Supply Chain (GSC) and other Gilead functions. We value leaders who foster an inclusive culture, empower employees, and drive performance in a collaborative environment. Responsibilities
Provide end-to-end clinical supply planning leadership from protocol design through manufacturing to distribution and inventory management of clinical supplies at sites worldwide.
Lead development and execution of overall clinical supply strategy for clinical development programs, including management of investigational medicinal product (IMP) for global trials.
Oversee and support clinical study planners in a matrix environment; facilitate issue and risk identification, mitigation, resolution and communication.
Drive cross-functional decision-making with ClinOps, PDM sub-teams and other functions to support long-term vision.
Identify, manage and mitigate supply risks at the program level and drive process improvements and organizational initiatives.
Author, revise and review SOPs, work instructions and business policies; maintain accountability for clinical supply budgets and approvals of SOWs, POs and invoices.
Influence or lead program allocations with partners and CMOs; participate in strategic initiatives within GCSC, GSC or PDM.
Knowledge and Skills
Ability to develop complex concepts, techniques, and standards; solutions to complex problems with ingenuity and innovation; experience in EU and international cGMPs.
Effective cross-cultural communication and collaboration across multinational agencies, sites and organizations.
Strong regulatory acumen with knowledge of FDA GxP standards and regulatory guidance (e.g., CFR, Annex 13, EU CTR); ability to support inquiries.
Excellent written and verbal communication; ability to write clear, concise, error-free documents and present to all levels.
Strong computer, database and organizational skills; ERP, planning systems and project management experience preferred.
Ability to manage resources and timelines for multiple studies with varying complexity; manage departmental and cross-functional projects.
Minimum Education & Experience
14+ years of relevant experience with a BS/BA; OR 12+ years with MA/MBA; OR 8+ years with PhD or PharmD.
Academic preference for science-related fields; MS, PharmD or MBA desirable.
Prior experience in complex oncology trials is highly preferred.
Experience in forecasting, demand/supply planning, IRT systems, inventory management, clinical labeling, distribution (including cold chain), import/export, reverse logistics, CMC and GXP regulations.
Strong collaboration, influencing and negotiation skills with internal and external stakeholders; ability to meet aggressive timelines.
Experience with clinical blinding practices in global studies (Phase 1 to late phase).
Experience sourcing and managing comparator drugs and co-medications for clinical studies; comparator sourcing strategy.
Expert knowledge of FDA GxP standards and regulatory guidance; ability to support regulatory inquiries.
Ability to lead through ambiguity and align options with Gilead culture and timelines.
Proficient in written and oral communication; ability to present to all levels.
Strong computer, database and organizational skills; ERP/planning systems experience a plus.
Ability to manage resources and timelines for multiple teams and studies with varying complexity.
Compensation and Benefits
The salary range for this position is: $221,000.00 - $286,000.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary by role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision and life insurance plans. For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to terms and conditions of applicable plans. Equal Employment Opportunity
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants, fostering an inclusive work environment with diverse perspectives, backgrounds, and experiences. Employment decisions are made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, disability, genetic information or other protected characteristics. Reasonable accommodation requests can be made to ApplicantAccommodations@gilead.com. For more information about equal employment opportunity protections, please view the Know Your Rights poster. Current Gilead Employees and Contractors
Please apply via the Internal Career Opportunities portal in Workday. Job Requisition ID R0047665 Full Time/Part Time: Full-Time Job Level: Director Click below to return to the Gilead Careers site
#J-18808-Ljbffr