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.
 

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.
 

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description
 

Gilead's mission is to discover, develop, and deliver therapies that will improve the lives of patients with life-threatening illnesses

worldwide.

JOB DESCRIPTION

Leads a team of CMC RA colleagues to drive global CMC regulatory strategy development for a portfolio of projects from early development through the early years of commercialization.Leads the execution of global CMC regulatory plans, including overseeing the submission preparation process in close partnership with other functions in PDM, Regulatory Affairs, and Clinical Development.Exercises expertise in the interpretation and implementation of ICH guidelines with a goal of right first time approval of a harmonized regulatory control strategy.Provides regulatory input to the Overall Control Strategy balancing process knowledge, manufacturing flexibility and Health Authority expectations.Promote the use of novel approaches within project teams to overcome unique challenges, and facilitate efficient global lifecycle management of CMC filings.Ensures regulatory conformance & consistency for assigned products globally in compliance with regulatory requirements and internal procedures.Evaluates and communicates regulatory risks and mitigation strategies for submissions 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 project team members to provide one CMC RA voice to PDM project teams regarding regulatory strategy and technical 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, participate in business process development initiatives or represent the company in industry consortia.

QUALIFICATIONS

A scientific degree with directly relevant professional experience in biologics product development, global CMC regulatory affairs, and CMC technical areas of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record of defining innovative global CMC regulatory strategies applied across a portfolio of projects.Experience with clinical submissions at all phases of development.Experience leading the preparation and submission of global marketing applications culminating in timely approval across major markets.Experience with preparing and leading health authority interactions with regulators globally.Demonstrated organizational leadership skills at a functional level.Experience leading or participating in cross-functional initiatives.Strong strategic thinking, decision making, and communication skills including experience presenting to senior leaders.Ability to influence cross-functionally to integrate regulatory thinking and requirements into development plans and activities.Demonstrated commitment to creating inclusion, developing talent and empowering teams.

People Leader Accountabilities:

•Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the

way they manage their teams.

•Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current

performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and

realize their purpose.

•Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding

them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

 

The salary range for this position is: $243,100.00 - $314,600.00. 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:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.

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 ApplicantAccommodations@gilead.com for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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 apply via the Internal Career Opportunities portal in Workday.