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Senior Manager, Enterprise Data and Analytics - R&D

Employer
Gilead Sciences, Inc.
Location
Raleigh, NC
Start date
Sep 21, 2022

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Discipline
Science/R&D, Research
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work
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Job Details


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.


Basic Qualifications:

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 Experience

Preferred 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.



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.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

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

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

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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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States
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