Technology Lead - R&D

Location
Raleigh, NC, United States
Posted
Jun 08, 2021
Ref
2285632
Required Education
Bachelors Degree
Position Type
Full time

Technology Lead - R&D
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

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 matters 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.

Specific Responsibilities and Skills

The R&D / PDM 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 / PDM 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 Regulatory 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 Regulatory 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 and Job Functions

General responsibilities for this position will include (but are not limited to) the following:

 

  • Partner with capability manager and 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, 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
  • Create/update and review system related documents including validation deliverables
  • Provide technical guidance to local support team as well as work with Managed Services partner for sustainment related activities
  • Work as the primary technical and delivery lead with Regulatory, Safety, Medical Affairs, and Data Science systems (EPRF, Label Change Tracker, Veeva Vault, RDMS, SPS)
  • On-site escalation point for technical issues primarly related to Regulatory and Safety systems.
  • 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.
  • 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 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 ensure 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 it relates 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. 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
  • Communicates proactively with the Project Manager and project team regarding project status
  • Partners with Quality Assurance (QA), IT Compliance and Validation resources to consult and review test plans and validation plans and ensure that issues are properly assigned, fixed, and regressed
  • 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
  • Participates in the creation of Request for Proposals (RFP) from a technical perspective.
  • 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
  • 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
  • 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
  • Develops, documents and shares technical delivery best practices.
  • Keeps abreast of industry trends and advancements in relevant technology
  • Consultative role on technical support areas, working closely with the System Manager
  • Partner with capability manager, global capability leads and portfolio managers 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, 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
  • Create/update and review system related documents including validation deliverables
  • Work as the primary technical and delivery lead with regulatory systems (EPRF, LCT, Veeva Vault, RDMS, SPS)
  • Provide technical guidance to local support team as well as work with Managed Services partner for sustainment related activities
  • On-site escalation point for technical issues related with R&D systems namely PV / Regulatory area.
  • 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.
  • 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.
  • Excellent interpersonal, communication, and business partnering skills
  • Strategic mindset with strong analytical foundation
  • 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
  • Advises clients/business analysts on discrete technology-related business problems, leveraging appropriate IT colleagues and/or vendors as appropriate. Formulates options including assessing their relative merits and risks, and works with clients/business analysts to determine the best solution.
  • Supervise a team of technical professionals, with full responsibility for performance management.
  • Acts as a technology mentor to team members.

 


Knowledge, Experience and Skills

Must have demonstrated implementation experience of Regulatory Systems, Drug Safety, Medical Affairs and Data Science 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.

 


Basic Qualifications

 

 

 

  • High School Degree and Twelve Year's Experience OR Associates Degree and Ten Years Experience OR Bachelor's Degree and Eight Years' Experience OR Masters' Degree and Six Years' Experience OR Ph.D

 


Preferred Qualifications

 

 

 

  • Experience in general pharmaceutical R&D area business processes
  • Experience working on various Pharmaceutical R&D systems like OpenText Documentum, Generis CARA, Lorenz docuBridge, Veeva Vault, Oracle Siebel, Argus, 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, & 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
  • Strong communication skills are a must
  • Experience in GxP applications (and Good Documentation Practices).
  • 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
  • Experience managing change control processes as a gatekeeper.
  • 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
  • Communication - Should be able to communicate with business stakeholders and be able to communicate complex solutions and value in business terms. Verbal communication skills are critical and the ability to adapt and learn to changing business environment and domains is a must
  • Bachelor's degree in IT, CS, Business Process Management or related discipline or an equivalent number of years of work experience
  • Experience in Life Sciences is a must.

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.

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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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:
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