- Drives and supervises team members to drive analytical control strategy development and justification in regulatory filings for projects throughout product lifecycle.
- Guides project teams on preparation of analytical filing content, and participates in authoring and reviewing of complex submissions and responses to questions from health authorities.
- Exercises expertise in the interpretation and implementation of ICH and regional guidelines with the goal of right first time approval of regulatory control strategies.
- Evaluates and drives the implementation of new regulatory and quality requirements for analytical control strategy in partnership with technical and manufacturing teams.
- Promotes continual improvement for analytical control strategies, quality compliance/business processes, and regulatory filing content taking into consideration internal experience and learning from the external environment.
- Ensures conformance to regulatory and quality requirements and internal procedures in the management of filing content and changes.
- Evaluates and communicates risks for CMC control strategies and quality compliance to CMC RA and PDM leadership.
- Develops meaningful and collaborative relationships with cross–functional teams and leaders across CMC RA and PDM.
- Works with CMC RA Team Leads to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical and quality risks.
- Demonstrates success in influencing without positional authority within a highly matrixed organization.
- Mentors and coaches team members to accelerate learning and professional development.
- Demonstrates and models Gilead's Core Values, Leadership Commitments, and People Leader Accountabilities.
- May have cross–functional leadership roles, and may participate in business process development initiatives or represent the company in industry consortia.
QUALIFICATIONS - A scientific degree with directly relevant professional experience in analytical chemistry or chemistry, with at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, or PharmD.
- Demonstrated track record defining analytical control strategy approaches for products taking into consideration existing and emerging ICH and regional guidance.
- Experience creating appropriate analytical control strategies attributes through product lifecycle.
- Experience with clinical, premarket and post market submissions preparation including resolution of complex regulatory questions while maintaining manufacturing and analytical flexibility.
- Strong strategic thinking, decision making, prioritization skills, and communication skills (written and verbal) including experience presenting to senior leaders.
- Ability to influence cross–functionally to integrate regulatory and quality thinking and requirements into development plans and activities. Experience leading or participating in cross–functional initiatives.
- Experience leading or participating in cross–functional initiatives.
- Demonstrated organizational leadership skills at a functional level.
- Demonstrated commitment to creating inclusion, developing talent and empowering teams.
Gilead Core Values - Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
The salary range for this position is: $237,660.00 – $307, 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:
Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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 for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
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Description
Senior Director – Analytical Regulatory ScienceUnited 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
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID–19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
We empower our leaders to step up, share ideas, listen, learn, and lead. We're welcoming bright, diverse, and imaginative minds; we're nurturing them to foster an environment of inclusion and growth where innovation is encouraged. We expect our people leaders to model that environment, and to focus on creating inclusion, developing talent, and enabling teams.
Every member of Gilead's team plays a critical role in the discovery and development of life–changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. Join Gilead and help create possible, together.
Job Description
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life–threatening diseases, including HIV, viral hepatitis, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.
Senior Director – Analytical Regulatory Science
KEY RESPONSIBILITIES
The Sr Director, Analytical Regulatory Science, is responsible for supervising a team of scientists, who collaborate with product development, manufacturing and quality teams on the construction, documentation and defense of the analytical control strategies in regulatory submissions preparation, review and approval. By balancing analytical knowledge and evolving regulatory expectations with manufacturing and analytical flexibility the incumbent will support "right first time" global approvals for CMC control strategies and maintain "right to operate" throughout the product lifecycle. In addition, the Sr Director will be accountable for leading the interpretation and implementation of new and existing CMC regulatory guidelines and regulations to ensure approvability globally. The incumbent will report directly to Head of CMC Regulatory Affairs – Systems and Operations at Gilead.
JOB DESCRIPTION
