Gilead Sciences, Inc.
* 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.* 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 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.* 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 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. #J-18808-Ljbffr
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. #J-18808-Ljbffr