Assoc Director, Clinical Operations-Early Phase

Responsibilities

• Lead execution of complex early-phase studies and/or multiple studies within a program, 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, resource planning, and execution planning.
• Accountable for study and program financial management, including forecasting, budget oversight, and resource allocation.
• Partner with Clinical Development, Clinical Pharmacology, Research, Regulatory, Biometrics, and other functions to align and deliver program objectives.
• Lead CRO/CRU/vendor selection, contract negotiations, and ongoing performance management.
• Influence program and organizational decision-making through operational expertise and data-driven insights.
• Lead or contribute to cross-functional and organizational initiatives, including transformation, change management, and continuous improvement efforts.
• Serve as a subject matter expert or Business Process Owner for Clinical Operations processes, SOPs, tools, and systems.
• Proactively identify study and program risks and implement mitigation strategies.
• Ensure compliance with global regulatory requirements, including FDA, EMA, ICH-GCP, and internal SOPs.
• Demonstrate leadership through influence across internal and external stakeholders.
• people manager responsibilities apply :
• Lead, mentor, and develop clinical operations staff, fostering a high-performance and inclusive culture.
• Provide coaching, feedback, and career development planning aligned with organizational goals.
• Empower teams through clear goal-setting, accountability, and removal of operational barriers.
• Oversee inspection readiness and support audit activities as needed.

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.
• 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 broader business objectives.
• Demonstrated experience with process improvement, innovation, or operational transformation initiatives.
• Excellent communication, collaboration, and stakeholder management skills.
• Ability to manage complexity, prioritize competing demands, and deliver results in a fast-paced environment.
• When needed, ability to travel.
• People Leader Accountabilities:
• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving

Benefits

Additional Information

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 The Associate Director, Clinical Operations is a key leadership role responsible for strategic planning, execution, and oversight of complex early-phase clinical trials and/or programs. This individual is accountable for operational delivery, financial stewardship, quality, compliance, timelines, and budget performance. This role operates at the program level, influencing cross-functional strategy, advancing operational innovation, and driving excellence across Clinical Operations. The position may include direct people management responsibilities or operate as a senior individual contributor, depending on business needs.

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