CDM Technology Manager

Gilead Sciences•Foster City, CA

10d

About The Position

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description 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 serve as the CDM Technology Manager for assigned activities of considerable complexity. You will typically oversee and guide the work of less experienced colleagues, including internal and contract personnel resources. You will typically lead special projects in support of CDM-related business activities. You may author CDM technical process/procedural documentation. You will demonstrate consistent effectiveness in managing complex projects and resolving problems in a multitude of CDM technical/solution domains, while ensuring adherence to quality standards and timelines.

Requirements

Degree(s) in computer science, health science, or related field preferred.
Some relevant years’ experience with PhD.
2 years’ relevant experience with PhD is preferred.
4+ years’ relevant experience with MA / MS.
6+ years relevant experience with BA / BS.
Multiple years’ EDC programming or CDM or other data analytics / data management experience, including experience and proven effectiveness leading small projects and project teams.
Experience implementing and training others in CDM technologies, data management and governance, or related practices, standards, processes, and tools.
Where applicable, demonstrates advanced proficiencies in multiple programming languages or supporting technologies.
Demonstrates ability to act as a SME in multiple standard and non-standard tasks performed by the assigned CDM Technology area, as evidenced by proven abilities to act as the CDM technical lead with increasing independence.
Demonstrated understanding of how CDM impacts product development goals, including understanding of the implications of data collection and handling decisions with cross-functional stakeholders.
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 strong track record of consistent achievement of project goals, deliverables and meeting expectations for quality, timelines, and budget.
Demonstrated ability and effectiveness identifying, communicating and escalating project-level issues, such as processes, timelines, resourcing, performance, etc.
Demonstrates strong facilitation / presentation skills and ability to appropriately delegate tasks to others.
Able to coach less experienced colleagues in solving problems.
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.
When needed, ability to travel.

Responsibilities

Serves as a lead for CDM technology support, which includes study-related activities and other initiatives, as well as overseeing the work performed by other internal colleagues and contract resources when applicable.
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.
Typically leads evaluation of project deliverables and timelines for assigned technology / related solutions tasks.
Typically leads CDM technology activities of considerable complexity, 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.
Typically participates in study, relevant project, and/or other team meetings and acts a lead CDM Technology representative to these teams/projects.
Typically plays an active or otherwise 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.
Responsible for ensuring work performed, whether directly managed or overseen, is consistently complete, correct, accurate, and in alignment with all requirements and business/timeline expectations.
Provides programming or other technology support and/or oversight of resources performing such for additional projects/deliverables as needed.
May author 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.
Typically leads special projects, such as new or updated technologies, tools, policies, procedures, or processes.
Ensures assigned work complies with established Gilead practices, policies, and processes, as well as regulatory or other requirements.

Benefits

This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits include company-sponsored medical, dental, vision, and life insurance plans.
For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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