R&D IT Info Systems Manager, Technology Lead Clinical DevOps

R&D IT Info Systems Manager, Technology Lead Clinical DevOps
United States - North Carolina - Raleigh

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes 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.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


About Gilead:

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

Specific Responsibilities & Skills:

The R&D IT group within IT department is responsible for working with functional business partners in the design, build, deployment, and support of business applications globally. For large, enterprise-wide programs, Technology personnel work in conjunction with the DevOps Lead and Capability manager against project objectives and have measured outcomes- typically leading the applications-related technical workstreams. R&D IT group also works closely with other cross-functional groups within IT namely Security, Worldwise Infrastructure Operations, and Enterprise Platform teams in the delivery of these capabilities leveraging Systems Life cycle (SLC) methodologies. This provides the mechanism for ensuring consistency and repeatability in how applications are delivered across the enterprise. This role specifically requires strong management and leadership experience to work with capability managers and functional business partners in the design, deployment, and support of business applications supporting the Clinical space within the Development Organization.

The Technology Lead, a primarily delivery-focused role, is responsible for the technical integrity of delivering application projects while providing technical guidance to business customers and IT project team members. This role has day-to-day lead accountability and leads the project delivery and Operations from a technical solution perspective supporting Clinical functional areas and works with IT DevOps Lead, Domain Architecture, PMO/other cross-functional groups within IT to perform evaluations and feasibility reviews of business need and/or technology solutions.

Essential Duties & Job Functions:

• Partner with capability manager, global capability lead and Portfolio lead to create the business case and Deliver the Projects to support Business strategy.
• Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope and timelines, SLAs and KPIs.
• Partner with the capability manager to capture, analyze and document functional requirements Specifications
• Translate business requirement to functional requirements and communicate them to technical teams
• 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.
• Works with the Project Manager, BPO, IT Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
• Partners with Quality Assurance (QA), IT Compliance and Validation resources Create/update and review system related documents including validation deliverables
• Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role
• Accountable for working with Business Process Owner, IT Compliance (for non-GxP systems) or QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable 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 ensure that the creation of project-specific documentation such as technical specifications are produced
• Communicates proactively with the Project Manager and project team regarding project status
• Participates in the creation of Request for Proposals (RFP) from a technical perspective.
• Work as the primary technical and delivery lead with Clinical systems (GILDA (CTMS), WinNonLin, Gilead Virology Database, etc. )
• Provide 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
• Defines technical strategies by performing evaluations, proof of concepts and assessments on the various technical aspects of the proposed project solution
• 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
• Ensures formal technical and technical performance reviews are conducted and provides feedback and suggestions
• Ensures that training design documentation and delivery from a technical perspective are in place
• On-site escalation point for technical issues related to Clinical systems.
• Ensures that project knowledge transfer occurs between project engineers and operational support staff
• Facilitates creation of control for all non-GxP and GxP change requests to meet compliance requirements
• Works with the project software vendor(s) technical teams to ensure adequate solution design
• Provides technical consulting and mentorship to coach, train and guide new or junior IT staff, such as to suggest training course options
• Serves as an advocate and endorses and enforces technological best practices in collaboration with solution architects
• Facilitates and coordinates technical guidance to IT senior staff, working closely with solution architects and engineers
• Ensures that technical delivery is in compliance with architecture and technical standards
• Keeps abreast of industry trends and advancements in relevant technology
• Work as the primary technical and delivery lead for Clinical systems
• Provide technical guidance to local support team as well as work with Managed Services partner for sustainment related activities
• Responsible for vendor management and leading external implementation resources partnering with Gilead towards the delivery of serialization and/or other commercial manufacturing projects.
• Responsible for drafting/reviewing high-level design and functional requirements for enterprise serialization systems and integration to packaging execution systems
• Support Validation/QA teams on ensuring GxP compliance of serialization and other commercial manufacturing systems with the corporate standard for IT change management and IT SOPs following 21 CFR Part 11 and Annex 11 requirements.

Knowledge, Experience & Skills:

• Must have demonstrated implementation experience of Clinical systems in a Bio-pharmaceutical industry.
• Laser-focused and strong delivery experience managing large, complex projects.
• Must think ahead strategically and must be able to weigh and decide between implementing new functionality by configuration vs assessment of new technology.
• 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
• Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
• Good understanding of GxP compliance and 21 CFR Part 11 requirements.
• Ability to drive continuous improvement across the team
• Ability to operate in a cross-functional / matrix environment
• High level of personal integrity consistent with Gilead's core values
• Ability to analyze complex business problems and evaluate solutions
• Ability to translate complex technical issues into business terms.
• Excellent analytical, problem-solving, and troubleshooting skills
• Excellent interpersonal, communication, and business partnering skills

Education & Experience:

• Typical candidates will possess 5+ years of relevant experience and BS in Computer Science or related fields or equivalent experience, or an MS and 5+ years of relevant experience.
• Experience in general pharmaceutical R&D area business processes covering Research to Release (R&D, PDM/Tech. Ops)
• Experience working on various Clincal area systems like Oracle Siebel, Phoenix WinNonLin, etc.
• Experience working with Computer System Validation in a GxP regulated area
• Experience with Agile, Scrum methodologies and DevOps, Cloud certification is a plus
• Professional written, verbal communications and interpersonal skills
• Ability to multi-task effectively & work independently
• Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
• Have the ability to support mission-critical business solutions using IT as a tool.
• Experience working with SaaS applications and monitoring service levels and deployment schedules
• Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
• Bridges gap between business and IT, for small/ simple IT systems and projects
• Track record working in a fast-paced, highly iterative environment
• Strong Listener: Be able to patiently listen to understand the business needs

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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