Risk Advisor, Risk Based Quality Management

Job Description

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 Risk Advisor, RBQM will act as a process manager 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.
• Contribute to the development and revision of 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.

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 8 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 6 or more years of clinical research experience
• Minimum of 3 years of experience in risk-based quality management, risk-based monitoring, or central monitoring, preferred
• 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, preferred
• Strong negotiation and conflict resolution skills
• 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