Associate Director, Clinical Operations-Early Phase

Responsibilities

• Lead the execution of complex early-phase studies and programs from planning through closeout
• Provide operational oversight to ensure delivery against timelines, budgets, quality standards, and regulatory requirements
• Drive program-level strategy, including study design input, feasibility, risk mitigation, and resource planning
• Manage study and program finances, including forecasting, budget oversight, and resource allocation
• Partner with cross-functional teams such as Clinical Development, Clinical Pharmacology, and Regulatory to align objectives
• Lead CRO/vendor selection, contract negotiations, and ongoing performance management
• Ensure compliance with global regulatory requirements, including FDA, EMA, and ICH-GCP
• Mentor and develop clinical operations staff, fostering a high-performance and inclusive culture

Requirements

• Bachelor's degree (or RN) with 10+ years of relevant clinical research or life sciences experience, OR
• Advanced degree (MS, MA, PharmD, PhD, MBA) with 8+ years of relevant experience
• Demonstrated experience leading complex clinical trials and/or programs
• Strong knowledge of global clinical regulations (FDA, EMA), ICH-GCP, and clinical trial processes

Preferred Qualifications

• Experience in early-phase clinical development
• Proven ability to lead cross-functional teams and influence without authority
• Experience with CRO/vendor sourcing and oversight
• Strong strategic thinking and ability to connect operational execution with business objectives
• Experience with process improvement, innovation, or operational transformation initiatives

About the Company

Gilead is a research-based biopharmaceutical company that has tackled diseases such as HIV, viral hepatitis, COVID-19, and cancer for more than 35 years. We work relentlessly to develop therapies that improve lives and ensure global access to life-changing scientific innovations.