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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
Director, Clinical Systems
Reporting to the Head of Clinical Systems, the Director, Clinical Systems provides functional leadership and technical oversight for technology solutions in support of Clinical Operations business needs. This role will provide thought leadership and will partner with Clinical Operations, information technology groups to enhance and improve clinical systems and infrastructure. As a manager of direct staff reports, the leader will provide guidance, coaching, project prioritization, and participate in goal performance discussions.
Core Responsibilities:
Partner with the leadership to deliver future-state capabilities which lead to robust, scalable solutions to support clinical trial activities and that align to IT enterprise strategy and cost of ownership.
Manages multiple projects and teams supporting multiple business areas or our largest and most complex technical workstreams.
This role will lead or participate in implementing strategic initiatives in collaboration with Clinical Operations and cross functional technical teams.
As Director of Veeva Clinical Vault owner (CTMS and eTMF) would be responsible for overseeing the implementation, configuration, and ongoing support of Veeva's CTMS and eTMF within life sciences companies, ensuring efficient clinical operations by optimizing system usage and aligning it with regulatory compliance, while collaborating closely with internal and external stakeholders to drive customer success with Veeva's clinical solutions.
Extensive knowledge in clinical trial operations and processes.
Provide technical support during regulatory inspections and internal audits.
Works with cross-functional Therapeutic Areas, R&D IT leaders to develop the short- and long-range technical strategy and roadmap for assigned business areas or key technical workstreams, including liaison with IT to schedule changes and updates
Be a change advocate, by stewarding and pioneering activities which focus on automation, simplification of processes and system design, and seeking methods to ensure strong interoperability amongst the larger clinical ecosystem
Leads definition and design and oversees implementation and execution of multiple initiatives within the assigned area, including appointing project teams and act as a technical leader
Act as the technical leader and spokesperson to cross-functional leaders and teams
Oversees and guides systems applications and other solutions development and configuration, including guiding the technical solution architecture when needed.
Oversees user or processes activities, including refining applications or other solutions to align with business process needs, including the definition and implementation of the short- and long-range technical roadmap for all data science deliverables owned by the team
Ensures business processes are created or updated and maintained to align with business and information systems needs and compliance requirements
Ensures timely, accurate and appropriate development and delivery of technical documentation and business process documentation
Partner with quality and the computer systems validation organization to ensure validation of GxP-related system activities are completed in compliance with regulatory requirements
Travels nationally and internationally as required.
Basic Qualifications:
Bachelor's Degree and Twelve Years’ Experience
OR
Masters' Degree and Ten Years’ Experience
OR
PhD and Eight Years’ Experience
Preferred Qualifications:
Veeva Clinical Vault (CTMS, eTMF, Site Connect, EDC etc.,) expertise.
Minimum of 6 years’ technical project management or other relevant leadership experience in a business environment, including multiple years’ managing project teams.
3+ years’ line management (direct reports) experience.
Demonstrated excellence in complex technical project management and effectively managing multiple projects and priorities
Proven ability to lead multifunctional regionally distributed teams, and to manage and develop employees
Demonstrated excellence in forging and maintaining collaborative, positive and long-lasting partnerships with system stakeholders: functional leaders, end-system user communities, IT, external partners
Experience negotiating and influencing stakeholders with respect to project scope, technology selections, and timelines.
High degree of organizational awareness and knowledge of change management with the ability to help teams anticipate, plan, and adapt to an evolving environment.
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives
Strong interpersonal skills and understanding of team dynamics
Strong negotiation and conflict resolution skills
Strong coaching capabilities to mentor and develop staff
Strong quality-orientation and attention to detail and accuracy
Applied understanding of computer system validation methodology, development, and execution
Proven ability to effectively communicate and present technical and advanced organizational concepts to internal and external customers
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.
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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