Associate Director, Connect Process

Gilead Sciences

Associate Director managing process improvements and quality readiness in Clinical Operations for Gilead. Leading initiatives and ensuring compliance with regulatory expectations in a fast-paced environment.

Posted 5/1/2026full-timeFoster City • California • 🇺🇸 United StatesSenior💰 $177,905 - $253,220 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.
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.
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)).

Requirements

What you’ll need

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
Project Management Fundamentals
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

Benefits

Comp & perks

discretionary annual bonus
discretionary stock-based long-term incentives (eligibility may vary based on role)
paid time off
company-sponsored medical, dental, vision, and life insurance plans

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

process managementquality controldata synthesisproject managementcompliance analysis

Soft Skills

interpersonal skillsnegotiation skillscollaborationcommunicationleadership

Certifications

Bachelor's degreeMaster's degreePhDProject Management Fundamentals