Associate Director, Clinical Operations

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $177.9k - $230.2k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1987

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Gilead Sciences is a leading biopharmaceutical company that focuses on discovering, developing, and delivering innovative therapeutics for patients with life-threatening diseases. The company is highly recognized for its contributions in virology, particularly HIV and hepatitis, and is actively expanding its therapeutic reach into fields like oncology and inflammation. Gilead has a strong pipeline of medicines, with over 25 products available globally and 50 clinical programs. Known for its commitment to health equity, the company also actively funds HIV research and causes. Gilead's dedication to scientific innovation and health equity aims to tackle the world's most pressing health challenges, improving patient lives globally.

📋 Description

• Provide input into strategic and operational short- and long-range therapeutic or functional area plans • Provide leadership, guidance, oversight and therapeutic expertise for clinical trials • Provide strategic, operational and financial oversight of assigned programs • Develop, implement, manage and complete clinical trials within designated budgets and timelines • Set the strategic vision for assigned clinical trials and programs • Assess, onboard and manage CROs and other vendors, including RFPs and selection processes • Contribute to Clinical Development Programs as a member of the Clinical Sub-Team and potentially the Global Development Team • Lead cross-functional Study Management Teams and influence stakeholders • Analyze project status and issues and implement risk mitigation strategies • Anticipate obstacles and implement solutions to achieve project goals • Address national and international regulations, guidelines and investigator interactions • Communicate project status and issues to stakeholders • Track, oversee and communicate program status using available tools • Contribute leadership input to study-related documentation, including protocols • Manage affiliate Clinical Operations activities required by local regulations or usual practice • Initiate, author or contribute to SOP development, implementation and training • Ensure team work complies with established practices, policies, processes and regulatory requirements • Hire, develop and retain diverse talent; set expectations; coach direct reports and support development of people leaders

🎯 Requirements

• Bachelor's Degree and Ten Years' Experience OR Master's Degree and Eight Years' Experience OR PhD/PharmD and 2 Years' Experience • Prior oncology clinical trials experience with at least 3+ years’ experience in the design and delivery of Phase 1 first-in-human (FIH) oncology clinical trials • Relevant clinical or related experience in life science • Typically a minimum of 6 years’ cross-functional study management or related leadership experience in life sciences • Multiple years’ experience managing study management or project teams • Experience developing RFPs and selection and management of CROs or other vendors • Proven ability to manage clinical studies within designated program budgets and timelines • Expertise in authoring clinical study and regulatory documentation and SOPs

🏖️ Benefits

• Discretionary annual bonus • Discretionary stock-based long-term incentives • Paid time off • Company-sponsored medical insurance • Company-sponsored dental insurance • Company-sponsored vision insurance • Company-sponsored life insurance