Global Clinical Supply Chain Manager

Gilead Sciences•Parsippany, NJ

1d•$123,930 - $176,440

About The Position

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come The Global Clinical Supply Chain Manager is a leader who carries out leadership vision and directions while providing expertise for Gilead's global clinical trials. They’ll work collaboratively within the department and with cross-functional colleagues (e.g., Regulatory, Clinical Operations, Quality, PDM sub-teams, GSC, etc.) to develop strategies, meet project deliverables, and solve business problems

Requirements

Bachelor's Degree and Six Years' Experience
Masters' Degree and Four Years' Experience

Nice To Haves

Strong working knowledge and experience in clinical supply management including and not limited to forecasting, demand / supply planning, distribution strategies, IVRS and ERP systems.
Working knowledge of clinical study designs, blinding practices, global trials, from Phase 1 first in human to late phase. Working knowledge of Clinical Demand and Operations Planning (CD&OP).
Experience with managing comparator drugs and other co-meds for clinical studies.
Ability to collaborate, influence and negotiate to work effectively with cross-functional teams and external suppliers to meet clinical development timelines and patient needs.
Works effectively with ambiguity. Ability to devise, assess and implement best options in alignment with Gilead's core values and functional expectations.
Excellent verbal, written, and interpersonal communication skills. Ability to write clearly and concise documents/presentations.
Strong computer skills (e.g., email, word processing, spreadsheet creation and management, online search, etc.). Ability to efficiently adopt systems and databases used at Gilead.
Ability to manage the resources and timelines for complex clinical study and programs. Project management experience is a plus.

Responsibilities

Interprets clinical study protocols and/or dosing schema. Translates the information to IMP demand and supply planning requirements, distribution strategies including depot inventory management.
Performs demand and/or supply forecasting and planning with planning horizon of 9 to 18 months.
Translate forecasts into clinical packaging and labeling (CPL) execution plans.
Supports contract/quote reviews and purchase order and invoice reconciliations.
Develop and implements depot and clinical site seeding and resupply strategies.
Carries out operational/logistics strategies and works with Quality Assurance, and other functional groups to execute strategies that ensure on time and safe delivery of all clinical shipments.
Collaborate with Logistics management and other members of GCSC, PDM and external partners to resolve shipping related issues. Escalates to senior leadership as needed.
Supports clinical development and PDM strategies working collaboratively within GCSC, Quality and other functional groups to develop clinical supply strategies and plans with the focus on delivering compliant, quality IMP to clinical trials globally on time in full.
Ensures accurate inventory and records at depots through timely reconciliation. Keeps abreast of clinical supply incidents and issues.
Reports and escalating issues as well as investigating root causes as appropriate.
Perform tasks in Gilead systems (e.g., SAP, IVRS, QMS, etc.) to enable compliant and efficient progression of IMP through the supply chain. Authors SOPs and business process work instructions as per leadership direction and support.
Supports regulatory filings and inspections.
Maintains compliance of clinical supply deliverables for clinical study reports (CSR) and trial master file (TMF).
Keeps abreast of all incidents related to shipment and reports trending to Quality Assurance and assists in creating CAPAs. Responsible for maintaining GDP, GMP, and global trade compliance.
Maintains compliance with required training.
Obtain and review quotes, approve purchase requisitions and invoices.
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem