Gileadhot
Sr Clinical Trials Manager
United States - California - Foster City · Senior
Sponsorship not specified$158k-$204kDetected 27 days ago
GCPLogisticsProcess ImprovementClinical TrialsFDA RegulatoryLeadershipCommunicationCollaboration
About the role
- Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations.
- We believe every employee deserves a great leader.
- People Leaders are the cornerstone to the employee experience at Gilead and Kite.
Responsibilities
- Lead all aspects of assigned clinical studies within a program, including Study Management Team leadership as applicable.
- Develop, implement, and oversee study plans, timelines, logistics, budgets, and resourcing.
- Identify study risks and proactively drive mitigation and issue-resolution strategies.
- Lead CRO and vendor selection, oversight, deliverable management, and relationship management as applicable.
- Partner with cross-functional stakeholders to align on study objectives, priorities, timelines, and deliverables.
- Mentor and support the development of less experienced colleagues.
- Clinical Operations leads the global execution of Phase I-IV clinical trials across therapeutic areas, ensuring studies are conducted in compliance with SOPs, company policies, and regulatory requirements while delivering timely, high-quality data to support registration and commercialization.
- The Senior Clinical Trials Manager leads studies within a program, provides direction to Clinical Operations team members, and is accountable for execution against timelines, budgets, and quality standards.
- This role develops study operational strategies and may contribute to cross-functional or organizational initiatives.
- Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
Requirements
- BA/BS with 6+ years of relevant clinical or related life sciences experience
- or MA/MS with 4+ years of relevant clinical or related life sciences experience.
- Comprehensive knowledge of FDA, EMA, other applicable national regulations, ICH guidelines, and GCP requirements governing clinical studies.
Nice to have
- Advanced degree such as MA/MS, PharmD, or PhD in a life sciences or related field.
- Experience leading clinical studies and cross-functional project teams.
- Clear, concise communication skills and strong interpersonal effectiveness.
- Proven ability to work successfully in a team-oriented, highly matrixed environment.
- Strong knowledge of full-cycle study management, from start-up through close-out.
- Advanced knowledge of study management best practices and tools, with demonstrated ability to improve study efficiency and effectiveness.
- Ability to travel as needed.
- People Leader Accountabilities:
Compensation
- $157,590.00 - $203,940.00.
- Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location.
- These considerations mean actual compensation will vary.
- This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Benefits
- include company-sponsored medical, dental, vision, and life insurance plans*.
- Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
- We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
Company info
- At Gilead, we're creating a healthier world for all people.
- Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact.
- As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations.
Equal opportunity
- In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance.
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