For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. 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.

We empower our leaders to step up, share ideas, listen, learn, and lead. We’re welcoming bright, diverse, and imaginative minds; we’re nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. 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. Join Gilead and help create possible, together.

Job Description

This position is in Foster City, California or may be located Remotely within the United States.

Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely and high-quality clinical data that supports global registration and commercialization of Gilead’s products. Residing within Clinical Operations, Risk Based Quality Management (RBQM) Strategy & Operations is responsible for implementing RBQM and Monitoring Plans in support of the Gilead portfolio.

The Associate Director, RBQM will act as a Risk Advisor for assigned area(s) and execute the RBQM process in clinical trials in adherence to ICH GCPs, regulations, and internal processes. This role will provide subject matter expertise and guidance to support teams with RBQM implementation. The Risk Advisor will contribute to the evolution of RBQM capabilities, lead and/or engage in change initiatives, and encourage an innovative mindset by championing new ideas, ways of working, and best practices.

RESPONSIBILITIES:

Study Risk Assessment

• Provide leadership, guidance, expertise, and training on RBQM in clinical trials.
• Advise study teams through risk planning, promoting cross-functional input and excellence in risk management.
• Provide input during the identification of Quality Tolerance Limits, risks, thresholds, mitigations, performance indicators, and signal interpretation.
• Participate in determination of monitoring requirements and mitigations in alignment with study and site risks.

Operational Excellence

• Manage RACT libraries and help drive consistency within programs and therapeutic areas.
• Manage RBQM processes, systems, templates, tools, and training materials.
• Lead or participate in committees, projects and/or work streams to support continuous improvement efforts .
• Contribute to the development and analysis of metrics to provide insight into RBQM performance and effectiveness.
• Support inspection-readiness and participate in audits and inspections to support requests for RBQM.
• Serve as a change agent, bridging RBQM knowledge across functions, sharing best practices, and developing effective partnerships with internal and external stakeholders.
• Stay abreast of RBQM-related regulations and industry practices.

Team Leadership

• May manage a team of direct and indirect reports, helping to hire, develop and retain diverse top talent. Coach direct reports on their performance, development, and career interests.
• Review workload and productivity for assigned staff, ensuring projects are suitably resourced and staffing needs are identified in a timely manner.
• Set clear goals for direct reports, coach direct reports on their performance and ensure team’s work complies with established policies, procedures, and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Bachelor’s degree with 10 or more years of clinical research experience in biotech or pharmaceutical industry (e.g., development, site management, site monitoring, clinical operations, data management) or master’s/doctoral degree with 8 or more years of clinical research experience.
• Minimum of 3 years of experience in risk-based quality management, risk-based monitoring, or central monitoring
• Minimum of 2 years of line management experience
• Experience across phases of development and multiple therapeutic areas preferred
• Experience successfully collaborating across multiple functional areas

Skills/Competencies

• Strong leadership presence with demonstrated ability to lead without authority and influence stakeholders across functions, cultures, and geographies
• Expert in RBQM strategies, processes, tools, and implementation
• Strong negotiation and conflict resolution skills
• Demonstrated strong capabilities in hiring, managing, and developing diverse top talent
• Demonstrated effectiveness in proactively managing change
• Strong computer skills, including expertise in Microsoft Office applications
• Excellent verbal and written communication and presentation skills
• English language fluency, both written and spoken
• Strong interpersonal skills and understanding of team dynamics, well-developed ability to build strong relationships
• Strong strategic thinking, analytical and problem-solving skills with above average attention to detail and aptitude for data analytics
• Ability to absorb knowledge of study design and therapeutic area and think critically, identifying risks and data trends, and managing issues
• Strong organizational and time management skills, able to work without direct supervision, manage competing priorities and deliver results on time and budget

Knowledge & Other Requirements

• Thorough knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies
• Knowledge of Phase I-IV clinical studies, clinical operations, and the roles of multiple functional areas which compose a study team
• Deep understanding of RBQM, risk-based monitoring, central monitoring methods, quality-by-design, risk and issue management, root causes analyses, and the cross-functional interfaces of RBQM
• Knowledge of RBQM IT systems, data flows across applications, including clinical and operational databases
• Aptitude for data analytics and understanding of basic statistical concepts
• When needed, ability to travel

The salary range for this position is: $168,980.00 - $218,680.00. 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*.

For additional benefits information, visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. 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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For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.