Associate Director, Clinical Operations

🔥 14 hours ago

🇺🇸 United States – Remote

💵 $177.9k - $230.2k / year

⏰ Full Time

🟠 Senior

🏥 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

• Lead teams of direct and indirect reports and manage talent development • Provide input into strategic and operational therapeutic-area and 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 budgets and timelines • Set strategic vision for clinical trials and programs through cross-functional collaboration • Assess, onboard, and manage CROs and other vendors, including RFPs and selection processes • Contribute to Clinical Development Programs as a Clinical Sub-Team member and potentially Global Development Team member • Lead cross-functional Study Management Teams and influence stakeholders • Analyze project status and issues and implement risk mitigation strategies • Solve problems involving national and international regulations, guidelines, and investigator interactions • Communicate project status and issues to stakeholders • Track, oversee, and communicate program status • Contribute leadership input to study documentation, including protocols • Oversee affiliate Clinical Operations activities required by local regulations or practice • Initiate, author, contribute to, implement, and train on SOPs • Ensure team compliance with practices, policies, processes, and regulatory requirements • Create inclusion, develop talent, and empower teams

🎯 Requirements

• Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD/PharmD and Two Years' Experience • Minimum of 6 years’ cross-functional study management or related leadership experience in life sciences (preferred) • Experience developing RFPs and selecting and managing CROs or other vendors • Multiple years’ line management experience • Experience managing clinical studies within designated program budgets and timelines • Expertise authoring clinical study and regulatory documentation and SOPs • Meets all requirements for Clinical Program Manager (CPM) grade 29 position with demonstrable proficiency • Expert knowledge of one or more disease or therapeutic areas • Complete knowledge of full-cycle study management, from start-up to close-out • Advanced knowledge of study management best practices and tools • Thorough knowledge of FDA, EMA, applicable national regulations, ICH guidelines, and GCP • Strong financial acumen for clinical trial budget management • Strong leadership, interpersonal, communication, organizational, negotiation, and conflict resolution skills • Demonstrated ability to lead without authority and influence programs, projects, and initiatives • Demonstrated capabilities in hiring, managing, and developing diverse talent • Demonstrated effectiveness in proactively managing change • Ability to travel when needed

🏖️ 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