Job Abstract

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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
 

Regulatory Affairs Business Operations believe talented people deserve a great place to work and excellence in our day-to-day operations enables talented people to do their best work!  Our Mission and Purpose is to reduce complexity, improve performance and to differentiate value.  In doing this we unleash and enable our people to be purposeful and impactful!
 

The Business Operational Excellence function works across Gilead Global Regulatory Affairs (GRA) to provide the framework for GRA process development and excellence, controlled documentation development and management and effective learning programs. In addition, leadership of the Incubation Hub will include oversight of all RSQ initiatives involving GRA.  The Business Operational Excellence Functional Head will play a leadership role in developing and implementing Global Regulatory Affairs infrastructure, compliance, process, and capability development.  The wider Business Operational Excellence team, incorporating Business Process Management and Excellence, the Quality and Compliance Centralized Process Team (CPT) and dedicated staff responsible for Regulatory Learning & Development, will partner closely across Regulatory Affairs and the wider Gilead organization to provide services including, but not limited to GRA business process support, audit readiness support, process improvement support, and compliance monitoring to support a wide variety of regulatory submissions across all therapeutic indications and regions.  The team will also identify, lead, and implement ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs capabilities (example: Manage Initiatives Portfolio, Manage Capability and Process Frameworks) across the global organization (US, EU, Japan, China, Australia, Canada, Intercontinental and Global Patient Solutions).

EXAMPLE RESPONSIBILITIES:

• Leads the Regulatory Business Process Management and Excellence Team, incorporating the wider Centralized Process Team (CPT) and Regulatory Learning & Development dedicated staff, with responsibilities for identification, development, refinement and continuous improvement of processes, standards, practices, efficiencies and capabilities within the Regulatory Affairs Department and wider company.

• Leads the incubation period for new process and departmental initiatives and appropriate RA capabilities (example:  Manage Initiative Portfolio, Manage Capability and Process Frameworks).

• Hires, develops, and retains diverse top talent on the team. Sets clear and elevating goals for the team and individual direct reports. Coaches team on their performance, development, and career interests.

• Makes significant contributions to our abilities to hire, develop and retain diverse talent with impact in and outside own team.

• Accountable for the successful oversight and completion of a broad spectrum of regulatory operational activities.

• Develops collaborations with key Regulatory and cross-functional stakeholders, to analyse and identify key business drivers and work with the Senior Leadership team to prioritise these, before driving implementation of agreed improved initiatives. 

• Interfaces with key internal business stakeholders and external groups including CONNECT, GLPS, R&D Quality and Medical Governance, and RSQ Outsourcing  

• Ensures suitable resources and skills are in place to deliver the required continuous improvement culture throughout Global Regulatory Affairs. Work with Regulatory functions to develop suitable training programs.

• Proactively identifies regulatory or related risks/issues and external leadership, governance ensures timely development of mitigation and decision-making forums, including /or contingency plans.

• Owns and manages budget and resource plans for assigned area and projections and tracking across the Global Regulatory Organization in close collaboration with the Head of Business Operations for Regulatory Affairs.

• Ensures team’s work complies with established practices, policies, and processes, and any regulatory or other requirements.

• Ensures suitable processes are in place for Global Regulatory Affairs to function efficiently and in compliance and tracking through to completion.

• Collaborates with the Head of Vendor Governance and Management Regulatory Affairs and coordinates provision of performance metrics on vendor use across the Global Regulatory Organization.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• Extensive experience leading global teams and projects in regulatory or related policies, strategies, programs, projects, and other activities.

• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.

• Experience working as a Global or Regional Regulatory Lead within one or more Gilead therapeutic areas and at varying stages of drug development is strongly preferred. 

• Multiple years’ line management (direct reports) experience. May have experience managing other people leaders (with indirect reports).

• Proven abilities to independently lead a diverse global team.

• Proven track record of achieving or exceeding large-scale, complex short- and long-range strategies in life sciences.

• Has a strong and established external network of regulatory, other governmental and industry leaders and decision-makers.

• Extensive experience interacting with and presenting to executives and managing large-scale project budgets and other resources.

• Experience and proven effectiveness working with regulatory authorities.

Knowledge & Other Requirements

• Expert knowledge of the drug development process, global and regional regulatory requirements, and other business functions, as evidenced by proven track record of leading organizations and teams to achieve short- and long-range strategies, plans and objectives.

• Organizational design and transformation leadership experience.

• May lead and individually contribute to the maturity of the RA Capability Development Framework

• Proven ability to influence up, down and across the organization and externally in a collaborative manner.

• Strong executive presence with demonstrated influence through leadership both on program teams and organizational initiatives.

• Exceptional interpersonal skills and understanding of team dynamics.

• Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans and strategic objectives.

• Strong negotiation and conflict resolution skills.  Advanced coaching capabilities to mentor/develop staff.

• When needed, ability to travel.

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.

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 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.

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