Senior Manager, Clinical PLM Systems

Senior Manager, Clinical PLM Systems

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. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

Specific Responsibilities:

The Senior Manager, Clinical Drug Product Systems will be the system lead for the Pharmaceutical Development & Technology (PDT) organization. They will be responsible for coordinating efficient master data management systems within an ERP environment, implementation of efficient knowledge management systems and representing PDT system needs. The Senior Manager will partner internally with PDT and externally with IT and Laboratory Information System (LIS) system owners within Pharmaceutical Development & Manufacturing (PDM).

The successful candidate will have detailed knowledge of product lifecycle management, clinical drug product development and building knowledge sharing platforms.

The successful candidate will be required to work across organizational, cultural and geographic boundaries to optimize company strategic results.

Responsibilities:

• Train formulators and engineers on Product Lifecycle Management (PLM) system for clinical drug product master data management
• Act as clinical drug product subject matter expert for PLM system
• Develop centralized knowledge management and communication platform(s) such as SharePoint
• Hands-on management of master data elements to create custom tools and visualizations for clinical drug product development
• Partner with clinical drug product teams to identify areas of improvement and translate these opportunities into deliverable solutions
• Lead the gathering, documentation, and management of system & process requirements
• Use informal management skills to work with cross-functional groups and contractors to ensure successful and timely deliverables
• Support strategy, roadmap management & process mapping to support future state supply chain models and strategic decisions
• Support project management of future state processes & implementation activities
• Ability to organize, define objectives and scope, identify tasks and milestones, build project schedules, identify resource needs, track project execution, & manage risks
• Gain an understanding of the enabling technologies supporting drug product development, single source of data, integrated applications and integrated business processes
• Supports analysis of Gilead policies, procedures, techniques, standards, and systems. Contributes to the development of new business processes and standards.
• Lead the preparation and communication of complex ‘current state' and ‘future state' documents.

Experience and Skills:

• Primary degree in Business, Science or Engineering discipline. Master's degree and/or professional qualifications desired.
• Lean/Six Sigma certification and APICS CPIM and CSCP certifications preferred
• Prefer 8+ years of experience in project/portfolio management role
• Prefer 8+ years of experience in clinical drug product development
• Experience in pharmaceutical operations/cGMP environment highly desirable
• Deep electronic system knowledge with an ability to identify and summarize business problems in the end to end context and pull the key stakeholders together to form cross functional responses
• Experience managing relationships with internal stakeholders and external business partners
• Demonstrates a collaborative mindset, nurtures teamwork and influences cross-functionally
• Excellent verbal and written communication including strong presentation and group speaking skills
• Excellent organizational skills
• Excellent project management skills
• Excellent analytical skills – ability to manage large datasets
• Must have a desire to learn new business operations
• Experience and command of coordinating contract staff

Minimum Qualifications:

• 8+ years of relevant experience in related field and a BS or BA; or 6+ years of relevant experience and a MA/MBA

Gilead Core Values

• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

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.​

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