Associate Director, Clinical Operations

🔥 15 hours ago

🇺🇸 United States – Remote

💵 $177.9k - $230.2k / year

⏰ Full Time

🔴 Lead

🏥 Clinical Operations

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Gilead Sciences

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $3.5M Post-IPO Debt - Gilead Sciences on 2024-11

Healthcare • Biotechnology • Pharmaceuticals

Gilead Sciences is a global biopharmaceutical company focused on researching, developing, and commercializing medicines primarily in virology, oncology, and inflammation. The company advances transformative therapies, runs extensive clinical programs and research collaborations, and supports access, global health, and community funding initiatives. Gilead also emphasizes corporate responsibility, sustainability, and inclusion while maintaining a broad pipeline of therapies and patient access programs.

📋 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 • Manage 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 the strategic implementation of 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 complex obstacles and implement solutions • Address national and international regulations, guidelines and investigator interactions • Keep stakeholders informed about project status and issues • Track, oversee and communicate program status using available tools • Contribute leadership input to study-related documentation, including study protocols • Oversee Clinical Operations activities conducted by the affiliate to support clinical trials • 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 on performance, development and career interests

🎯 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 • 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