Sr. Director, RWE Business Operations

Job Description

Sr Director, RWE Business Operations

Specific Responsibilities:

Gilead Sciences is currently seeking an RWE Business Operations lead to serve as a thought partner to the RWE leadership team to help design and implement initiatives for business planning, strategic development and operational excellence in direct support of the growth of the RWE function.  This role coordinates efforts towards development of the Gilead RWE ecosystem and champions continuous improvement activities.

This role will be responsible for working with stakeholders across RWE, CDS, Development, Research, Commercial, and other organizations to help develop and operationalize such initiatives.  The candidate will have a proven success record of collaborating across drug development functions to define and implement policies, processes and best practices that enable evidence generation to support internal and external program decisions.
 

Specific responsibilities include:

• Coordinate efforts to develop the RWE ecosystem addressing expertise, organization, processes, resources, data and technology platforms
• Defines and implements the operating and cost models to enable RWE strategic goals and establish RWE capabilities
• Facilitates definition and implementation of metrics to monitor RWE value and results
• Partners with RWE LT on resource planning and budget management
• Partners with RWE team and program governance processes to operationalize RWE studies and deliverables
• Enables definition and implementation of the engagement model to request and deliver RWE analysis, method and data expertise
• Collaborates with RWE, Bridge and other subject matter experts to define operational processes and procedural documents (SOPs, WRKs, etc.) to support implementation of RWE studies, deliverables and services
• Collaborates with Bridge and other stakeholders on development and delivery of training plans and materials
• Supports RWE teams in defining and managing end-to-end data lifecycle processes
• Partners with Development Systems and other stake holders to implement systems, platforms and technologies to manage real-world data (RWD) and analyses
• Ensures development, implementation and ongoing enhancement of data governance processes
• Facilitates data governance forums to support decision making around data acquisition, data usage and data sharing
• Ensures new regulations are interpreted and incorporated into processes and procedural documents
• Drives standardization and best practices to optimize cross-functional RWE processes and deliverables
• Defines and implements effectiveness and efficiency metrics for performance monitoring and oversight
• Monitors operations and drives continuous process improvement in partnership with RWE, Bridge, CDS and other stakeholders

• Triages program/process-level gaps and issues, and works on risk mitigation with the RWE team

Knowledge, Experience, and Skills:

• BA/ BS with 14+ years’ relevant process, scientific or relevant experience in the biopharma industry, or 12+ years’ relevant experience with MA/MS/MBA or PhD/PharmD, or 6+ years’ relevant experience with MD
• Knowledge of biopharma industry drug development and governance processes
• Experience with process optimization and data management best practices
• Significant experience leading or co-leading large-scale, highly complex cross-functional process development and process optimization initiatives. 
• Proven effectiveness in leading and managing change management programs
• Ability to align diverse stakeholders and drive teams to achieve a common goal
• Ability to navigate complex, ambiguous situations and changing priorities to deliver results
• Ability to synthesize inputs from various stakeholders into coherent deliverables and outputs
• Line management (direct reports) experience; ability to collaborate flexibly with virtual and remote team members and colleagues

About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.