Gilead Sciences
Associate Director, Clinical Systems
Gilead Sciences, San Mateo, California, United States, 94409
Associate Director, Clinical Systems
United States - California - Foster City Clinical Development & Clinical Operations Regular Job Description
At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gileads 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 were 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 Associate Director, Clinical Systems Reporting to 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/contractors, the leader will provide guidance, coaching, project prioritization, and participate in 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. 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. 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 CTMS strategic initiatives in collaboration with Clinical Operations and cross functional technical teams. Partner and communicate regularly with other members of the IT organization to facilitate a unified team. Communicate clearly and regularly with the organization on implementations, outages, and changes in tools and processes. Facilitate workshops to collect business requirements, validate and document business requirements. 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 acts 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. Ensures 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 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 Ten Years Experience OR Masters' Degree and Eight Years Experience OR PhD and Two Years Experience Preferred Qualifications: PhD with 6+ years relevant technical support, development or business analysis experience in a business environment. MA/ MS with 8+ years relevant technical support, development or business analysis experience in a business environment BA/ BS with 10+ years relevant technical support, development or business analysis experience in a business environment. Veeva Clinical Vault (CTMS, eTMF, Site Connect, EDC etc.,) is a must. Extensive knowledge in clinical trial operations and processes. Minimum of 5 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.
#J-18808-Ljbffr
United States - California - Foster City Clinical Development & Clinical Operations Regular Job Description
At Gilead, were creating a healthier world for all people. For more than 35 years, weve 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 worlds biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gileads 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 were 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 Associate Director, Clinical Systems Reporting to 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/contractors, the leader will provide guidance, coaching, project prioritization, and participate in 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. 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. 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 CTMS strategic initiatives in collaboration with Clinical Operations and cross functional technical teams. Partner and communicate regularly with other members of the IT organization to facilitate a unified team. Communicate clearly and regularly with the organization on implementations, outages, and changes in tools and processes. Facilitate workshops to collect business requirements, validate and document business requirements. 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 acts 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. Ensures 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 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 Ten Years Experience OR Masters' Degree and Eight Years Experience OR PhD and Two Years Experience Preferred Qualifications: PhD with 6+ years relevant technical support, development or business analysis experience in a business environment. MA/ MS with 8+ years relevant technical support, development or business analysis experience in a business environment BA/ BS with 10+ years relevant technical support, development or business analysis experience in a business environment. Veeva Clinical Vault (CTMS, eTMF, Site Connect, EDC etc.,) is a must. Extensive knowledge in clinical trial operations and processes. Minimum of 5 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.
#J-18808-Ljbffr