Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to pursuing scientific invention to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.
You will be part of a team that is helping millions of people live healthier, more fulfilling lives. We are a close community where every individual matter and everyone has a chance to enhance their skills through ongoing development. Inclusion is one of our core values, which means we are creating and fostering a work environment where our differences are valued, and everyone feels respected and empowered to bring their authentic selves to work. By joining Gilead, you will further our mission to discover, develop and deliver innovative therapeutics for people with life-threatening diseases.
The Gilead Business Services center in Raleigh's Research Triangle region will be home to some of the company's critical shared service teams in North America, including Information Technology, Global Financial Solutions, HR Operations and Procurement Services Desk. These functions provide the necessary support to ensure Gilead's business runs effectively and efficiently. The center will also be a catalyst for standardization of processes, digital transformation and technology optimization.
The Senior Manager, Enterprise Data and Analytics - R&D will be responsible for leading enterprise data and analytics initiatives in R&D. Individual will be responsible for maturing and extending analytical solutions, data management, data engineering, metadata management and master data management solutions in R&D organization. By combining a strong technical background with a solid understanding of domain knowledge, the individual will architect, design and deliver projects and enhancements across for R&D.Essential Duties and Job Functions
- Partners with Enterprise Data & Analytics R&D/PDM and Deliver the Projects to support Business strategy.
- Partners with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.
- Partners with the capability manager to capture, analyze and document functional specifications
- Translates business requirement to functional requirements and communicate them to technical teams.
- Acts as System Manager and create/update, review system related documents including qualification/validation deliverables in primary business areas of focus.
- Develops subject matter expertise within junior IT staff in overall Advanced Analytics space.
- Provides support for technical implementation activities during functional requirements and design, cost and timeline estimation, and assist in the management and communication to Gilead's stakeholders.
- Accountable for working with Business Process Owner, IT Quality Assurance (QA) and/or Regulatory Compliance (RC) to identify the appropriate System Life Cycle model based on applicable regulatory requirements before presenting estimates for input to new system business case or change implementation plans.
- Leads or assists with scoping, identification of project deliverables, project time estimations, resource level estimations and ensures that the creation of project-specific documentation such as technical specifications are produced.
- Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution.
- Owns the delivery of the overall technical workstream or one or more technical modules of the project under development by leading and managing the technical delivery team.
- Understands the end-to-end technical architecture for the solution being developed. Acts as a point of technical escalation and resolution during the project lifecycle as related to technical decisions.
- Determines and provides the necessary level of technical documentation during requirements gathering, based on technical services standards and procedures and discussions with the project team and technical vendors.
- Partners with Project Managers (PMs) to develop the technical delivery work plan and schedule and ensures that appropriate technical delivery staffing resources are assigned, and effectively utilized.
- Partners with IT QA, Compliance and Validation resources to consult and review test plans and validation plans and ensures that issues are properly assigned, fixed, and regressed.
- Ensures that training design documentation and delivery from a technical perspective are in place.
- Facilitates creation of control for all GxP change requests to meet compliance requirements.
- Partners with external business partners to meet the technical project needs as appropriate.
- Works with the project software vendor(s) technical teams to ensure adequate solution design.
- Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects.
- Responsible for vendor management and leading external implementation resources partnering with Gilead towards the delivery of SAS, R and Python based systems and/or other Advanced Analytics Solutions.
- Supports Validation/QA teams on ensuring GxP compliance of R&D Analytics systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.
- Supervises a team of technical professionals, with full responsibility for performance management.
High School Degree and Twelve Years Experience OR Associate's Degree and Ten Years Experience OR Bachelor's Degree and Eight Years Experience OR Master's Degree and Six Years ExperiencePreferred Qualifications:
- Experience in general Pharmaceutical industry in R&D area business processes.
- Hands on experience with implementation of SAS, R and Python.
- Hands on experience in managing roadmap execution including tech transfer/scale-up, process implementation and validation.
- Detailed understanding of Advanced Analytics Landscape in R&D.
- Working knowledge of regulatory requirements in biopharmaceutical and good understanding of GxP compliance and 21 CFR Part 11 requirements.
- Has a strong working understanding of installed systems, with the ability to troubleshoot and resolve any problems on the existing system(s) supported and is aware of integration points with other systems.
- Experience working with Computer System Validation in a GxP regulated area.
- Deep understanding of Clinical Trials business processes like study management, protocol development, site management, needs of different trial phases, clinical site constraints, manufacturing and CMO constraints, etc.
- Experience working with SaaS applications and monitoring service levels and deployment schedules.
- Strong communication skills, written, verbal, & interpersonal skills are a must.
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