Director, Risk Based Quality Management

Getting Hired; United States; Remote; USD 191,000 - 248,000; Full time

Job summary

A leading biotech company is looking for an experienced leader in Risk-Based Quality Management (RBQM). This role requires over 12 years of clinical research experience and a strong track record in managing global programs. The successful candidate will oversee collaborations, ensure compliance with regulations, and promote operational excellence. A Bachelor's degree is required, with strong leadership and analytical skills necessary for success. Competitive salary package with benefits offered.

Benefits

Discretionary annual bonus

Paid time off

Company-sponsored medical, dental, vision insurance

Qualifications

• 12+ years of clinical research experience in biotech or pharma.
• Minimum of 5 years in RBQM and central monitoring.
• 1+ years as a Clinical Research Associate or Study Coordinator.

Responsibilities

• Serve as a Lead Subject Matter Expert and Process Owner.
• Lead collaborations with CRO partners for RBQM.
• Manage RBQM activities and support inspections.

Skills

Leadership presence

Expertise in RBQM strategies

Strong negotiation skills

Analytical skills

Effective communication

Education

Bachelor’s degree

Master’s/Doctoral degree

Tools

Microsoft Office

Job description

Overview

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.

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.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. 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. Join Gilead and help create possible, together.

Job Description

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide.

Responsibilities

RBQM Leadership and Partnerships

• Serve as a Lead Subject Matter Expert and Process Owner for assigned areas, processes, and technologies.
• Lead collaborations with CRO partners to ensure continuous improvement and alignment with Gilead’s RBQM framework, including representing RBQM in governance committees.
• Provide oversight of vendors performing RBQM activities, ensuring effective, high quality, and timely delivery of portfolio requirements.
• Support inspection-readiness and participate in audits and regulatory inspections, serving as a point of contact for RBQM.

Study Risk Assessment and Mitigations

• Provide expert guidance, training, and support on RBQM in clinical trials, ensuring adherence to ICH GCPs, regulatory requirements, and internal processes.
• Advise study teams throughout risk management activities, fostering cross-functional collaboration, and promoting excellence in risk management.
• Contribute to the development of new central monitoring tools to address risks and support study oversight, contribute to the identification and definition of Quality Tolerance Limits, risks, thresholds, mitigations, performance indicators, and develop the study’s Central Monitoring plan.
• Participate in determining monitoring strategies and mitigation plans aligned with study and site risks, including authoring the Central Monitoring Plan.
• Facilitate cross-functional risk review meetings with study teams, collaborating in risk signal interpretation and triage, ensuring effective communication and resolution of issues.
• Oversee timely resolution of risk signals and issues identified through central monitoring, ensuring appropriate escalation and documentation.

Operational Excellence

• Lead the development, enhancement, and implementation of RBQM processes, systems, templates, tools, and training materials to support operational efficiency and scalability.
• Manage RACT libraries, driving consistency across programs and therapeutic areas.
• Lead or actively contribute to cross-functional committees, projects and workstreams focused on continuous improvement and innovation.
• Develop and analyze RBQM performance metrics to assess compliance, effectiveness, and areas for optimization.
• Serve as a champion for change initiatives by fostering an innovative mindset, bridging RBQM knowledge across functions, and promoting new ideas, best practices, and modern ways of working.
• Build and maintain strong partnerships with service providers, influencing strategic relationships and ensuring high-quality deliverables.
• Represent Gilead in industry-wide collaborations, contributing thought leadership and sharing best practices.
• Stay current with RBQM-related regulations, trends, and industry standards to continuously improve the RBQM framework, processes, technologies, oversight, and compliance.

Team Leadership

• May manage a team of direct and indirect reports, supporting the recruitment, development, and retention of diverse top talent.
• Provide coaching and mentorship to direct reports, aligning performance feedback with individual development goals and career aspirations.
• Establish goals and expectations for direct reports, regularly reviewing performance and ensuring team deliverables adhere to internal processes and regulatory requirements.
• Oversee workload distribution and productivity across assigned staff, ensuring projects are appropriately resourced and staffing needs are proactively identified.
• Monitor and support staff retention efforts, ensuring turnover rates remain within expected thresholds.
• Ensure timely completion of required training for assigned staff and promote a culture of continuous learning and compliance.

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 12+ years of clinical research experience in the biotech or pharmaceutical industry (e.g., clinical development, site management, site monitoring, clinical operations, or data management) or a Master’s/Doctoral degree with 10+ years of clinical research experience Or 8 years of relevant experience with a PhD.
• Minimum of 5 years of experience in RBQM and central monitoring
• Minimum of 1 year of experience as a Clinical Research Associate or Study Coordinator
• Minimum of 2 years of line management experience
• Demonstrated experience across multiple phases of clinical development and therapeutic areas
• Proven ability to collaborate effectively across multiple functional areas

Skills/Competencies

• Strong leadership presence with the ability to lead without authority and influence stakeholders across functions, cultures, and geographies
• Deep expertise in RBQM strategies, processes, tools, and implementation
• Proven success in managing large-scale global programs and projects
• Strong negotiation and conflict resolution skills
• Demonstrated ability to hire, manage, and develop diverse top talent
• Effective in proactively managing organizational change and driving innovation
• Expert-level proficiency in Microsoft Office applications
• Excellent verbal, written, and presentation communication skills
• Fluent in English, both written and spoken
• Strong interpersonal skills and understanding of team dynamics; able to build and maintain strong relationships
• High cross-cultural competency and global collaboration experience
• Strategic thinker with strong analytical and problem-solving skills; highly attentive to detail and skilled in data analytics
• Ability to quickly absorb study design and therapeutic area knowledge; think critically to identify risks, interpret data trends, and manage issues
• Outstanding organizational and time management skills; able to work independently, manage competing priorities, and deliver results on time and within budget

Knowledge & Other Requirements

• Thorough knowledge of national and global regulations and guidelines governing clinical research
• Deep understanding of Phase I-IV clinical studies, clinical operations, and the roles of cross-functional study team members
• Advanced expertise in RBQM, including risk-based monitoring, central monitoring methodologies, quality-by-design principles, risk and issue management, and root causes analyses
• Strong knowledge of RBQM-related IT systems and data flows across clinical and operational applications and databases
• High aptitude for data analytics and a solid understanding of basic statistical concepts
• Ability to travel as needed

People Leader Accountabilities

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Compensation and Benefits

The salary range for this position is: $191,250.00 - $247,500.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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.

For more information about equal employment opportunity protections, please view the Know Your Rights poster.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinions. Our environment respects individual differences and recognizes each employee as an integral member of our company.

Please apply via the Internal Career Opportunities portal in Workday if you are a current Gilead employee or contractor.