SVP, Regulatory, Safety, & Quality

SVP, Regulatory, Safety, & Quality
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. Gileads 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 companys five core values. Thats 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

Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. As part of our rapidly growing science-driven organization, colleagues at Gilead are revolutionizing healthcare by bringing urgently needed medicines to patients in the areas of HIV/AIDS, liver diseases, hematology and oncology, inflammation and respiratory diseases and cardiovascular conditions. We are proud to have some of the most talented colleagues from across the research, healthcare, pharmaceutical, biotechnology & business sectors, working together and supporting each other to help make a real difference to the lives of patients.

SVP, Regulatory Affairs, Safety, and Quality

Core Responsibilities:

• Delivery Excellence: Leads the Global Regulatory Affairs, Safety, and Quality functions: serves as the key Gilead interface with external regulatory bodies; Oversees regulatory strategy and submissions throughout a product's lifecycle from investigational new drug (IND) to loss of exclusivity (LOE), including lifecycle extension activities; Accountable for the maintenance of Gilead's global portfolio of product licenses and management of associated regulatory and safety commitments; Manages the organization responsible for signal detection and signal management, benefit-risk evaluation, reference safety information, pharmacovigilance audits, and inspection preparation; Ensures the organization is inspection-ready across all functions through continuous education, training, and internal audits; Drives continuous improvement in the day-to-day operations of the Regulatory, Safety, and Quality functions and seeks opportunities to continually enhance cross-functional effectiveness; Leads the Quality organization to oversee and ensure Good Clinical Practice and Healthcare Compliance for Gilead internationally; Oversees drug safety practices, activities, and personnel for ongoing clinical trials, post-marketing commitments, and registries and for the preparation of submission packages
• Strategic Thinking: Guides the development of global regulatory strategies that focus on maximizing the probability of regulatory success and expediting approval while balancing risk and maintaining compliance; Seeks to accelerate development plans and drives the development of novel regulatory pathways, program,s and tools (e.g. Breakthrough Status, vouchers, real world evidence); Interprets regulations on behalf of Gilead and works cross-functionally to develop a point of view on how regulations apply to Gilead and what actions, if any, are necessary; Prioritizes key regulatory issues for Gilead and oversees the development of a strategy and plan for Gilead to engage and influence external policy makers on these matters
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• Influence and Partnership: Forms strong, collaborative partnerships with other Gilead functional leaders to plan, execute, and troubleshoot global development programs; Partners with R&D, Compliance, CMC, and other functions to provide early insight and feedback to influence decisions that facilitate the product approval process; Plays a pivotal role in representing Gilead's interests externally, and shaping global regulatory policies; Partners with other industry regulatory leaders, where appropriate, in a pre-competitive fashion to address macro issues affecting the industry;
• Understands industry best practices and regulatory requirements that affect benefit-risk evaluations, new drug applications, and changes to labeling and marketing authorization; Partners across the Development organization to establish and ensure GCP and healthcare compliance globally.

Additional Responsibilities:

• Innovation: Keeps current with advances in regulatory, quality, and safety science and overall drug development; Actively monitors how competitors are interpreting regulations and navigating the regulatory landscape and looks for novel ways for Gilead to apply these learnings; Assists with the regulatory implementation of novel trial designs and endpoints; Seeks opportunities to utilize data and technology to enhance internal regulatory, safety, and quality decision-making and operations
• People Development: Attracts industry-leading talent and grows leaders; Develops others by identifying and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others
• Decision-making: Guides and leads teams in a cross-functional organization to partner and work effectively with all aspects of R&D, including research, clinical, process development, and program management; Maintains current knowledge of the regulatory environment by reviewing and implementing current policies/practices issued by U.S. federal and international regulatory agencies
• Communication: Advocates on behalf of Gilead and effectively communicates complex medical/clinical concepts in both written and oral communication to both internal and external stakeholders

Capabilities and Requirements:

• You have robust drug development experience and have a strong command of the evolving global regulatory environment and policies
• You have considerable experience engaging with global regulatory authorities and have successfully navigated regulatory approvals, post marketing commitments, and responses to regulatory findings
• You have played an active role in shaping and influencing global regulatory policies
• You have relevant experience with Good Clinical Practice, Healthcare Compliance, and Quality
• You have the ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions
• You have excellent oral and written communication skills, including the ability to translate between business leaders, scientists and technologists
• You have the credibility and reputation to attract and retain top talent with a history of creating teams that can thrive in a fast-paced, matrixed environment
• You have leadership, collaboration, relationship building, and interpersonal skills

Education and Qualifications:

• MD or equivalent
• 15+ years of biopharmaceutical drug development experience and regulatory leadership
• Direct experience interacting with FDA and other international health authorities; proven responsibility for the development of biological drug candidates through regulatory milestones is required

Gilead Core Values

• Integrity (Doing What's Right)
• Inclusion (Encouraging Diversity)
• Teamwork (Working Together)
• Excellence (Being Your Best)
• Accountability (Taking Personal Responsibility)

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. 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.

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.

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.


To apply, visit https://gilead.wd1.myworkdayjobs.com/en-US/gileadcareers/job/United-States---California---Foster-City/SVP--Regulatory--Safety----Quality_R0012790-1





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