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Associate Director, Clinical Operations
Gilead Sciences. Provide input into strategic and operational short- and long-range therapeutic or functional area plans .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing oncology clinical trials, including strategic oversight, budget management, and regulatory compliance. Proven leadership in cross-functional team management and vendor selection processes, with a focus on achieving project goals within established timelines.
Highest-signal resume keywords
Oncology Clinical Trials ExperiencePhase 1 First-In-Human (FIH) Trial DesignCross-Functional Study ManagementClinical Study Documentation AuthoringCRO Management and RFP Development
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementBudget ManagementRegulatory ComplianceRisk Mitigation StrategiesSOP DevelopmentProject Status AnalysisStakeholder CommunicationClinical Development ProgramsVendor Selection ProcessesTeam Leadership
Soft Skills
LeadershipCoachingInfluencing StakeholdersProblem-SolvingCommunication
Tools & Technologies
Clinical Operations ToolsProject Management Software
Industry Keywords
Life SciencesClinical DevelopmentTherapeutic Area PlansStudy Management TeamsNational and International Regulations
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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