Sr. Manager Data Science - Clinical Data Management

Job Description

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 advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Job Overview

Clinical Data Management (CDM) supports drug discovery, development, and marketed products across Gilead by ensuring accurate and timely acquisition, analysis and reporting of clinical data. CDM Technology provides technical services in support of CDM and cross-functional teams, including data collection standards, analysis and reporting, lab data management, Electronic Data Capture (EDC), and new technology/solution evaluation, implementation, and management activities, as needed. Given the nature of their work, CDM Technology works closely with internal CDM colleagues, as well as other partner organizations involved in drug development, including study and relevant project teams, Gilead IT, and various external vendors.

You will lead projects to evaluate and advance CDM and/or cross-functional team productivity, effectiveness, and capabilities. You will typically represent CDM Technology on departmental and cross-functional strategic initiatives and projects. You will demonstrate advanced capabilities in anticipating and communicating potential technical/process challenges which may impact study/management teams and/or related projects. You will act as a subject matter expert (SME) to study/management teams on CDM technical systems and processes, as well as associated deliverables.

Example Responsibilities:

• Serves as a lead for CDM technology and other solutions support, which includes study-related activities as well as other initiatives, and overseeing the work performed by one or more teams of other internal colleagues and/or contract resources. Dependent upon area of assignment, may have CDM technology responsibilities for multiple studies or other projects across a therapeutic area or other key workstream for CDM.
• Leads CDM technology activities of considerable complexity across multiple projects concurrently, which may include clinical/business data analytics, reporting, and/or technical design of study or other project elements as well as associated administration and quality checks.
• Uses a variety of programming languages, software, and techniques; including Python, Groovy, SQL, etc. as necessary to support analysis of operational data for CDM and cross-functional stakeholders.
• Generates dashboards and data visualizations to support analyses of business processes.
• Defines and implements technological infrastructure from Database to ETL processes in support of data pipeline projects.
• Leverages Cloud Development operation systems, such as AWS and Azure DevOps, to support data repository and reporting projects.
• Builds, implements, tests, deploys and maintains innovative data solutions to improve business operations, including machine learning and natural language processing where applicable.
• Leads special projects, such as new or updated technologies, tools, policies, procedures, or processes.
• Acts as a consultant and specialist advisor to CDM and cross-functional leaders and teams on the short- and long-range CDM technical direction for multiple studies or other projects in one or more therapeutic areas and/or key workstreams.
• Typically contributes to the short- and long-range CDM Technology strategy that may influence the direction of one or more therapeutic areas.
• Leads evaluation of project deliverables and timelines for assigned technology / related solutions support teams.
• Participates in study, relevant project, and/or other team meetings and acts a lead CDM Technology representative to these teams/projects.
• May play a leadership role in determining internal and/or external resourcing requirements to support assigned projects and other work, including determining the appropriate allocation of such resources. May work with vendors to negotiate and confirm contract resources in financial and non-financial areas, such as resourcing, adherence to timelines, productivity, and quality.
• Responsible for ensuring work performed across assigned deliverables and team(s) is consistently complete, correct, accurate, and in alignment with all requirements and business/timeline expectations.
• Typically authors process, procedural, or other key documentation that transcends or otherwise pertains to multiple activities across CDM Technology.
• On-boards, trains, and mentors less experienced colleagues. Trains internal, external, and/or vendor partners on CDM technologies, policies, procedures, processes, or other related matters.
• Ensures assigned work complies with established Gilead practices, policies, and processes, as well as regulatory or other requirements.

Minimum Education & Experience:

• Degree(s) in computer science, health science, or related field preferred.
• Some relevant experience with PhD. 4 years’ relevant experience with PhD is preferred.
• 6+ years’ relevant experience with MA / MS.
• 8+ years relevant experience with BA / BS.
• Significant experience in EDC programming or CDM or other data analytics / data management experience, including experience leading increasingly complex projects and project teams responsible for technical support for biopharma clinical studies and related projects.
• Significant experience leading special projects and initiatives, such as new or updated technologies, policies, procedures, processes, standards, or other key capabilities.
• Experience implementing and training others in CDM technologies, data management and governance, or related practices, standards, processes, and tools.

Knowledge & Other Requirements:

• Demonstrates advanced proficiencies in multiple programming languages or supporting technologies.
• Experience utilizing data lakes, data warehouses and big data storage and platforms.
• Demonstrates advanced business and technical expertise, as evidenced by the ability to act independently, contribute to short-and long-range CDM Technology strategies, and act as the CDM technical lead for multiple or all projects in a therapeutic area or key workstream that impacts multiple CDM teams.
• Demonstrates advanced knowledge of FDA / EMA / etc. regulations, IND/NDA/BLA and other regulatory requirements, and EDC/CDM systems, including advanced knowledge of submission requirements and standard industry formats for clinical data.
• Has strong project and risk management skills, including demonstrated ability to work within budget constraints while using resources efficiently and in a fiscally responsible manner.
• Has knowledge of CDM or general data analytics and data management best practices and tools and has shown ability to apply this to improve decision-making effectiveness and efficiencies.
• Demonstrated effectiveness in examining complex CDM technical issues from various perspectives using appropriate CDM concepts and resources.
• Demonstrated strong track record of consistent achievement of project goals, deliverables and meeting expectations for quality, timelines, and budget.
• Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.
• Demonstrated ability to be a fast learner.
• Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
• Strong communication and organizational skills.
• Ability to lead and influence programs, projects and / or initiatives.
• When needed, ability to travel.

Gilead Core Values:

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