Associate Director, Connect Process

Gilead Sciences•Foster City, CA

23h

About The Position

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.

Requirements

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
Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies
Fluency with Microsoft Office suite, including MS Visio and Project
Strong interpersonal and negotiation skills
Awareness of change management strategies being implemented across cross-functional teams
Synthesizes inputs from various stakeholders into coherent deliverables and outputs
Collaborates flexibly with virtual and remote team members and colleagues
Directs multiple projects in alignment with overall business objectives
Communicates complex datasets and findings to relevant stakeholders
Strong leadership presence with demonstrated ability to lead without authority and influence programs, projects and/or initiatives.

Nice To Haves

Project Management Fundamentals
Navigates projects amidst ambiguous situations and changing priorities
Manages multiple projects while monitoring quality work product from self and team
Aligns stakeholders, manages project scope, and drives teams to achieving timelines
Analyzes problems and logically structure problem-solving strategies to resolve identified/anticipated
Strong change champion with a good understanding of change management strategies

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