Gilead Sciences, Inc. is hiring an Associate Director, Clinical Data Science Compliance Oversight

At our organization, we're dedicated to creating a healthier global environment. For over three decades, we've confronted significant health challenges like HIV, viral hepatitis, COVID-19, and cancer – working persistently to develop transformative therapies and ensure worldwide accessibility. We remain committed to addressing global health issues through collaborative, determined efforts. Every team member at our organization plays a crucial role in pioneering scientific innovations. Our workforce represents our most valuable asset as we pursue ambitious goals, seeking passionate individuals ready to create meaningful impact. We firmly believe exceptional leadership is fundamental to employee experience. People Leaders are instrumental in evolving organizational culture and establishing environments where individuals feel included, developed, and empowered to achieve their potential. Join us in creating extraordinary possibilities. The Associate Director, Clinical Data Science Compliance Oversight will be accountable for designing, implementing, and optimizing quality capabilities supporting Clinical Data Science to foster continuous improvement and heighten awareness regarding quality management system accountability. This position requires comprehensive understanding of Good Clinical Practices and regulatory requirements governing clinical trials. The role involves partnering with key stakeholders to enhance trial portfolio quality, address compliance challenges, and implement risk management strategies. Job Responsibilities: - Spearhead quality strategy development and implementation supporting Clinical Data Science objectives - Supervise quality review of clinical trial documentation, workflows, and outputs ensuring regulatory compliance - Conduct trend analysis to identify process improvements and corrective action opportunities - Drive quality-focused initiatives based on emerging insights and observations - Provide expert compliance guidance to study teams - Collaborate with audit and inspection management teams on internal reviews and regulatory interactions - Coordinate with business experts to resolve audit outcomes and manage corrective actions - Serve as Change Champion for quality management system communications - Analyze regulatory updates with emphasis on Good Clinical Practices - Cultivate quality commitment across organizational ecosystem Basic Qualifications: Bachelor's Degree and Ten Years' Experience OR Masters' Degree and Eight Years' Experience OR PhD and Two Years' Experience Preferred Qualifications: - Extensive experience advising pharmaceutical industry functions on quality and compliance requirements - Comprehensive background in quality and compliance activities - Proven track record of cross-functional project participation - Familiarity with Quality Management Systems - Demonstrated expertise in clinical trial and drug development processes Knowledge & Requirements: - Comprehensive understanding of regulatory guidelines - Thorough knowledge of drug development processes - Strong analytical capabilities - Strategic relationship-building skills - Ability to provide senior leadership guidance on compliance matters People Leader Accountabilities: - Foster inclusive team environments - Develop individual employee potential - Empower teams through strategic alignment Salary Range: $165,495.00 - $214,170.00, with compensation determined by experience, qualifications, and geographic location. Potential additional benefits include annual bonus, stock incentives, comprehensive insurance plans. Our organization is committed to equal employment opportunities, celebrating diverse perspectives and creating an inclusive workplace free from discrimination. We welcome individuals from all backgrounds and provide reasonable accommodations as needed.