Senior Clinical Trials Manager

Responsibilities

• Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership.
• Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
• Ensure studies are delivered on time, within budget, and in alignment with quality, protocol, SOP, and regulatory requirements.
• Identify study risks and proactively drive mitigation and issue-resolution strategies.
• Lead CRO and vendor selection, oversight, deliverable management, and relationship management.
• Partner with cross-functional stakeholders to align on study objectives, priorities, and deliverables.
• Provide guidance, training, and direction to internal team members, CROs, vendors, and investigators.
• Mentor and support the development of less experienced colleagues.

Requirements

• BA/BS with 6+ years of relevant clinical or related life sciences experience; or MA/MS with 4+ years of relevant clinical or related life sciences experience.
• Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.

Preferred Qualifications

• Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
• Experience leading clinical studies and cross-functional project teams.
• Demonstrated ability to lead teams, coach, and mentor less experienced colleagues.
• Strong knowledge of full-cycle study management, from start-up through close-out.
• Proven ability to work successfully in a team-oriented, highly matrixed environment.
• Ability to travel as needed.

About the Company

Gilead is 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.