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R&D IT Capability Sr Manager, Product Owner - Patient Safety & Medical Affairs

Employer
Gilead Sciences, Inc.
Location
Raleigh, NC
Start date
Oct 1, 2022

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Job Details

R&D IT Capability Sr Manager, Product Owner - Patient Safety & Medical Affairs
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 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.

Job Summary:

The R&D IT group within IT department is responsible for working with functional business partners to the design, build, deploy, and support business applications in R&D area globally. R&D IT group also works closely with other cross-functional groups within IT such as Project Management Office, Enterprise Architecture, Security, Worldwide Infrastructure Operations, and Enterprise Platform teams to ensure capabilities are delivered leveraging Gilead's Systems Life cycle (SLC) methodologies. This provides the mechanism for ensuring consistency and repeatability in how technology is delivered across the enterprise.

Gilead is seeking a product owner who has the ability to deliver global capabilities to market for the Patient Safety (Pharmacovigilance) and Medical Affairs domains. Product owner will work with the business partners to develop strategic capability roadmaps with focus on driving business value. Product owner will be responsible for developing business cases, financial estimates, return on investment metrics for projects and ensure projects are launched on time. Furthermore, product owner is required to understand changes in the industry, perform market scans for capability with a focus on innovation. Product owner also supports evaluations and feasibility reviews of business need and/or technology solutions in partnership with business and R&D IT delivery group.

This role specifically requires strong management and leadership experience to work with delivery teams and business partners in the design, implementation, deployment. For large, enterprise-wide programs, product owner typically co-leads the business workstreams with business process owners. Ultimately, the product owner is accountable for the value a project, or an initiative provides for the business.

Specific Responsibilities and Skills:
  • Proactively seeks out opportunities, actively monitors and identifies capability gaps and proposes potential solutions through research internally and externally.
  • Act as a thought leader in Patient Safety (Pharmacovigilance) and Medical Affairs domains ensuring the team continues to innovate and delivers business value & efficiency.
  • Document process workflows and frameworks to facilitate discussions with business stakeholders.
  • Participates in requirements discussions and design review of systems.
    • Prepare business requirement documents (BRD).
  • Develops business cases for new projects & initiatives to support business strategy.
    • Business cases are developed with clear objective, business value justification and return on investment metrics.
    • Ensures timely project approval submissions occur following both quarterly and annual cycles by working with IT project management office.
    • Assists in identification of project deliverables, project time estimations and resource level estimations.
    • Prepares financial estimates by working the cross functional IT and business teams.
  • Responsible for keeping capabilities maps associated with relevant technologies up to date for Patient Safety (Pharmacovigilance) and Medical Affairs.
  • Participates in the Request for Approval (RFP), reviews statement of work and license agreements.
  • Manages strategic relationships with product vendors, holds periodic review sessions to ensure Gilead business needs are prioritized.
  • Ensures clear communication occurs among cross functional teams, sets clear expectations, and serves as an escalation account manager for the business.
  • Partners with Validation and QA teams to ensuring GxP assessments and Validation scope for projects are well understood.


Knowledge, Experience and Skills:
  • Must have demonstrated system implementation and management experience of Pharmacovigilance and Medical Affairs systems areas 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 of existing technology vs assessment of new technology.
  • Has a strong working understanding of installed systems, is aware of integration and data flow points with other enterprise systems.
  • Demonstrates proficiency with one or more technology environments, with the ability to learn and apply new and emerging concepts very quickly.
  • Excellent interpersonal, communication, and business partnering skills
  • Strategic mindset with strong analytical foundation
  • Ability to analyze complex business problems and evaluate solutions
  • Ability to translate complex technical issues into business terms.
  • Good understanding of GxP compliance and 21 CFR Part 11 requirements.


Minimum Qualifications:
  • Associate's Degree and 12 years' experience OR Bachelor's Degree and 10 years' experience OR Master's Degree and 8 years' experience OR PhD and 2 years' experience


Preferred Qualifications:
  • Experience in general pharmaceutical R&D area business processes covering Patient Safety (Pharmacovigilance) and Medical Affairs
  • Experience working on various Pharmaceutical R&D systems for Patient Safety (Pharmacovigilance) and Medical Affairs like Argus, Eclipse, Safety Reporting System, IRMS, Veeva Vault (MedDocs/PromoMat), iEnvision, etc.
  • Experience working with Computer System Validation in a GxP regulated area
  • Experience with Agile, Scrum methodologies and DevOps, Cloud certification is a plus
  • Experience with Salesforce Apps is a plus.
  • Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
  • 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



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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., Canada, Australia, Singapore, and Hong Kong 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:


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






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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.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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