Director, Process Development, Clinical Data Science Bridge

Director, Process Development, Clinical Data Science Bridge
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

For Current Gilead Employees and Contractors:

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

Job Description

Director, Process Development, Clinical Data Science Bridge

The Bridge team provides operational support for the Clinical Data Science (CDS) organization via procedural development, training, quality expertise, and change communication. Bridge is seeking a Director, Process Development to join our Leadership Team. In this role you will lead a team of direct and indirect reports in supporting process development, documentation, and communication for functional areas within CDS. This role will also contribute to the definition and direction of process development policies and procedures, continuous improvements in standards and tools, and reportable metrics to monitor processes.


Job Responsibilities:

• Provide expert direction to team in prioritizing, planning, and overseeing both routine and complex activities involving procedural documentation, process management, and process improvement to completion
• Influence the future direction and capabilities of the Bridge team by identifying and leading activities that build efficiencies, automation, standardization and the adoption of best practices across CDS
• Extract added value and improved results by increasing standards and expectations across team members, recurring activities, and projects
• Collaborate with key internal and external stakeholders and subject matter experts to assess process alignment and prioritize revisions as necessary to ensure continued relevance and applicability
• Define systems or processes to consistently ensure the high standards required in the organization, periodic review of procedures and documents, and provide mechanisms to track changes
• Perform content review and quality control for a portfolio of documents to drive alignment with Gilead policies and best practices
• Represent CDS in cross-functional projects and activities related to procedural development
• Design a strategy to manage junior staff and develop their capabilities in alignment with organizational priorities
• Foster a commitment to quality in individuals and a culture of quality within the organization
• Serve as an ambassador of Good Documentation Practices that assure GxP compliance and data integrity, and oversee application of the controlled document hierarchy across CDS
• Synthesize complex data and present recommendations clearly to senior leadership
• Support budget creation and resource allocation decision-making within the organization
• Advise on the development and delivery of internal training materials

Knowledge and Skills

Project Management Fundamentals

• Manage multiple projects amidst ambiguous situations and changing priorities, while monitoring quality work product from self and team
• Align and synthesize inputs from various stakeholders to drive teams toward a common goal and coherent deliverables and outputs
• Execute change management effectively across cross-functional teams

Interpersonal Skills

• Demonstrated ability to effectively hire, manage, develop and retain diverse top talent, as evidenced through past experiences and effectiveness mentoring and developing less experienced team members
• Excellent verbal and written communication skills
• Consistently communicate a clear and elevating vision that effectively aligns and mobilizes the team, as evidenced by consistently on- or above-target results
• Understand impact of decisions and actions on business and consults with appropriate colleagues and management as applicable
• Collaborate flexibly with virtual and remote team members and colleagues
• Leverage risk-based rationale to facilitate decision-making

Core Technical Skills

• Fluency with Microsoft Office suite, including Visio and Project
• Ability to analyze problems and use logically structured approach to resolve identified challenges
• In-depth knowledge of process development; experience leading business process improvement projects
• Recognized as a knowledgeable resource within the department and from other departments
• Familiarity with drug development or highly regulated environments, understanding of current industry trends and GCP regulations

Education and Experience

• 12+years of relevant experience with a Bachelor's degree
• 10+ years of relevant experience with a Master's degree
• Includes 2 years of relevant experience in the biotechnology or pharmaceuticals industry
• Familiarity with drug development process and GxP

For jobs in the United States:

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 careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

PAY TRANSPARENCY NONDISCRIMINATION PROVISION

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

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






jeid-82d9adcd5969494e9f4f260370f86408