Senior Clinical Data Management Technology Manager

Senior Clinical Data Management Technology Manager
United States - California - Foster City

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

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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

Sr. Clinical Data Management Technology Manager:

POSITION 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 a small to mid-size team of direct reports and may manage other people leaders. You will be responsible for overseeing CDM Technology project teams to execute assigned activities. You will ensure appropriate consultation with study/management teams on CDM technical solution systems and processes, as well as associated deliverables. You may act as CDM technical lead for multiple projects/workstreams. You will act as a subject matter expert (SME) to study/management teams on CDM technical solution systems and processes. 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.

EXAMPLE 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.
• 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.
• May serve 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 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.
• Leads evaluation of project deliverables and timelines for assigned technology / related solutions support teams.
• Leads and/or oversees CDM technology support 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 quality checks.
• Participates in or oversees team's support in study, relevant project, and/or other team meetings and may act a lead CDM Technology representative to these teams /projects.
• 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.
• May author process, procedural, or other key documentation that transcends or otherwise pertains to multiple activities across CDM Technology.
• May act as system administrator for systems managed by CDM (Medidata Rave, TrialGrid, Jira, Confluence, etc.).
• 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.
• Leads special projects, such as new or updated technologies, tools, policies, procedures, or processes.
• Adheres to regulatory requirements, industry standards and Gilead SOPs and ensures the same across own team.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Degree(s) in computer science, health science, or related field preferred.
• Some relevant years' 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.
• Experience leading special projects and initiatives, such as new or updated technologies, policies procedures, processes, standards, or other key capabilities.
• Experience contributing to the technical strategy for CDM or a related function in biopharma.

Knowledge & Other Requirements

• Demonstrated effectiveness coaching, guiding, and directing the work of others, effectively managing performance of others, and developing team capabilities.
• Demonstrated strong track record of consistent achievement of project goals, deliverables and meeting expectations for quality, timelines, and budget.
• Where applicable, demonstrates advanced proficiencies in multiple programming languages or supporting technologies.
• 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.
• Demonstrated effectiveness in examining complex CDM technical issues from various perspectives using appropriate CDM technologies, concepts, and resources.
• 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.
• Demonstrates the ability to organize and manage projects using systems such as Azure DevOps, Jira, etc.
• 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.
• Understands Risk Based Quality Management concepts and their applications regarding efficient data cleaning.
• 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.

The salary range for this position is: $165,580.00 - $214,280.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. 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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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 ApplicantAccommodations@gilead.com for assistance.

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For Current Gilead Employees and Contractors:

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






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