Associate Director, Connect Process

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
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

The Clinical Trial Capabilities (CTC) organization offers infrastructure, support, and solutions enabling the Clinical Operations and Development Organizations with rapid, efficient, and compliant clinical trial execution to deliver transformative medicines to patients. The Connect function within the CTC organization is a centralized process department that specializes in process improvements, procedural documents, and quality and inspection readiness for Clinical Operations.

The Associate Director, Connect Process supports process analysis and documentation for the Clinical Operations organization within a fast-paced and highly regulated environment. In addition, they may have multi-project responsibilities and serve as a project manager as needed on complex initiatives and working groups.

Key Responsibilities:

• Drives assigned initiatives/projects and working groups ensuring progression to achieve timelines.

• Oversees Clinical Operations process management/improvement and associated procedural documentation in collaboration with business process owners, cross-functional stakeholders, and subject matter experts.

• In collaboration with R&D Quality's Process, Documentation & Learning team, provides expert direction to teams to business process owners, cross cross-functional stakeholders, and subject matter experts

• Performs content review and quality control for a portfolio of documents ensuring alignment with Gilead policies, procedures, and best practices

• Proposes and implements plans to resolve organizational process issues and execute process-related corrective actions resulting from inspections/audits

• Determines actions required to achieve team goals and leverage junior staff accordingly and manage junior staff and develop their capabilities in alignment with organizational priorities

• Synthesizes operational/performance/compliance data and present business cases clearly to initiative review committee(s)

• Collaborates with key stakeholders to assess process alignment and prioritize revisions as necessary to ensure continued relevance and applicability of processes and associated procedural documents

• Collaborates with Clinical Operations and/or Development change management leads to ensure appropriate change management strategies are defined and executed

• Collaborates with Connect Learning and advises on the development and delivery of training  

• Collaborates with Connect Quality and implements process changes resulting from audits/inspections

• Drives standardization and the adoption of best practices across the Clinical Operations organization

• Ensures Clinical Operations processes and associated procedural documents are aligned with industry and regulatory expectations/regulations (i.e. 21 CFR, ICH E6 (R2))

• Leads and supports efforts to increase compliance awareness, a culture of compliance and inspection readiness

Basic Qualifications:

• Bachelor's degree and 10+ years of relevant experience; OR

• Masters' degree and 8+ years of relevant experience; OR

• PhD and 5+ years of relevant experience

Preferred Qualifications:

Project Management Fundamentals

• Navigates project