Associate Director, Clinical Data Science Compliance Oversight

Description

Job Responsibilities :

• Lead in the development and implementation of quality strategy and associated capabilities to support the CDS objectives
• Manage quality review of clinical trial documents, workflows, and outputs within the CDS organization to ensure clinical trials are conducted in compliance with Gilead procedures, GCP and applicable global regulations
• Analyze trends to identify process gaps, improvement opportunities and areas requiring corrective / preventive actions
• Lead new quality focused initiatives focused on new learnings, findings, and observations to continuously improve CDS quality practices and methods
• Work closely with Gilead CDS study team to provide expert advice on compliance issues and risk mitigation actions
• Collaborate with the audit, inspection and CAPA management team within Gilead R&D Quality on internal audits, regulatory agency inspections, risk assessment, deviations and CAPA activities
• Liaison and coordinate with business experts and stakeholders to support resolution of audit outcomes which require further action or response. Partner closely with business units to lead, track and manage corrective actions or risk mitigation activities
• Serve as a Change Champion for Gilead QMS-related communications to the CDS organization consolidating and channeling just-in-time information and resources to prepare the organization for change
• Analyze new regulations and polices with emphasis Good Clinical Practices (GCP) and partner with business experts and stakeholders to update internal documentation and practices accordingly based on areas of impact
• Foster a commitment to quality in individuals and a culture of quality across the CDS organization and with CDS related service providers

Basic Qualifications :

Bachelor's Degree and Ten Years’ Experience

OR

Masters' Degree and Eight Years’ Experience

OR

PhD and Two Years’ Experience

Preferred Qualifications :

Knowledge & Other Requirements :

People Leader Accountabilities :

The salary range for this position is :

Bay Area : $182,070.00 - $235,620.00.Raleigh : - .

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 :

For jobs in the United States :

Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, 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 for assistance.