Assoc Director, R&D Information Systems

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

This position in Clinical Systems provides technical solutions data and analytics to support business needs across R&D. The roleis responsible forpartnering with stakeholders to deliver and continuously enhance Clinical Systems platforms applications integrations and analytics capabilities. This includes contributing to technology strategy overseeing system implementation and support activities and ensuring solutions meet business quality compliance and operational requirements.

Clinical Systems designs develops testsvalidates maintains and improves technology solutions supporting clinical operations including the preparation and delivery of user training management of technical documentation enhancement of system capabilities and collaboration with cross-functional teams. Responsibilities include supportingGxP-compliant system validation activities user acceptance testing and participation in regulatory inspections and internal audits as needed.

The Associate Director will work directly with business stakeholders vendors and technical teams to understand business needs and translate them into scalable and sustainable technology solutions. This role oversees multiple projects manages a team of professionals and/or consultants and drives execution of strategic initiatives while contributing to the long-term Clinical Systems roadmap.

The ideal candidate combines strong technical and business acumen with leadership capabilities a customer-focused mindset and a passion for improving R&D processes through innovative technology and data solutions.

Responsibilities

As an Associate Director R&D Information Systems you will:

• Lead end-to-end Clinical Systems migration initiatives (Eg: CTMS eTMF study startup and related ecosystem applications) from strategy planning and due diligence through implementation cutover stabilization and decommissioning of legacy platforms.

• Drive acquisition merger and divestiture system integration activities including assessment of acquired clinical data study portfolios operational processes system landscapes and migration strategies to ensure business continuity and regulatory compliance.

• Lead cross-functional data migration programs including data profiling mapping transformation reconciliation remediation validation and archival activities ensuring data integrity traceability and inspection readiness across the clinical trial lifecycle.

• Provide executive leadership for large-scale modernization programs (like CTMS) managing multiple vendors CROs business stakeholders and technical teams while overseeing migration risks dependencies cutover planning operational readiness and post-go-live support.

• Partner with business stakeholders to understand operational challenges and deliver technology solutions that support Clinical Operations and broader R&Dobjectives.

• Lead the strategy implementation enhancement support and continuous optimization of Clinical Systems data integrations and analytics capabilities.

• Drive and oversee CRO integrations by partnering with cross-functional stakeholders and external vendors to ensure seamless data exchange and operational alignment.

• Lead cross-functional efforts for data migrations including acquisitions collaborative studies andsystem modernization initiatives;facilitatediscussionson data transformation quality and remediation activities with system and business leaders to ensure successful outcomes.

• Manage multiple concurrent projects and workstreams balancing priorities resources timelines and budgets to ensure successful delivery.

• Contribute to the development and execution of Clinical Systemsdata andtechnology roadmaps aligned to business strategy and organizational priorities.

• Partner with cross-functional stakeholders and technical teams to drive solution design architecture development validation and infrastructure activities ensuring the successful delivery of scalable reliable and compliant Clinical Systems solutions.

• Manage and develop a high-performing team of employees and/or contractors providing coaching performance feedback and career development support.

• Oversee system lifecycle activities including requirements gathering design testing validation deployment and ongoing support.

• Ensure delivery of high-quality solutions that meetGxP regulatory security and data integrity requirements.

• Partner with Quality and Validation teams to support system validation audit readiness and inspection activities.

• Drive continuous improvement initiatives to improve business processes system adoption operational efficiency and user experience.

• Collaborate with vendors and external partners to ensure successful delivery and support of technology solutions.

• Monitor project risks dependencies and issues proactively implementing mitigation strategies whereappropriate.

• Support the development of budgets resource plans and investment proposals for Clinical Systems initiatives.

• Promote data-driven decision-making through effective reporting analytics and operational insights.

• Ensure adherence toestablishedpolicies processes and technology governance standards.

Basic Qualifications

• MS/MA/MBA degree and significant relevant experience

Preferred Qualifications

• Significant years of experience supporting clinical pharmaceutical biotechnology or healthcare technology environments. Experience leading technology projects or programs supporting clinical development or R&D organizations.