Associate Director, Clinical Operations
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Job Description
Clinical operations leader overseeing oncology clinical trials, budgets, vendors, and cross-functional teams at Gilead. Driving development of therapies for serious diseases.
Responsibilities:
- 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
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