VP, Global Regulatory Strategy Head, Oncology, Inflammation - Foster City, United States - Workday

Description

For Current Gilead Employees and Contractors:

Please log onto your

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At Gilead we believe every employee deserves a great leader.

As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.

Job Description

Gilead Sciences, Inc. is a research-based biopharmaceutical 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 Create Possible and improve the care of patients living with life-threatening diseases around the world.

Gilead's therapeutic areas of focus include Oncology, Inflammatory Diseases, and Virology.

Our portfolio of more than 25 marketed products includes an antibody-drug conjugate for the treatment of certain patients with unresectable locally advanced or metastatic triple-negative breast or locally advanced or metastatic urothelial cancers, two CAR T therapies approved for the treatment of adult patients with certain B cell lymphomas or Mantle Cell Lymphoma, and innovative complete treatment regimens for HIV and chronic hepatitis C infection available in once-daily single pills.

Since its founding in Foster City, California, in 1987, Gilead has become a leading biopharmaceutical company with a rapidly expanding product portfolio, an impressive pipeline of investigational drugs across therapeutic areas, and over 14,000 employees in offices across six continents.

Millions of people around the world are living healthier lives because of innovative therapies developed by Gilead.

Today, our innovative approach to external partnerships, and our internal research and development effort include hundreds of ongoing and planned clinical studies evaluating compounds with the potential to become the next generation of effective medicines.

The VP, Global Regulatory Strategy Head, Oncology, Inflammation, & Precision Medicine will be accountable for the definition and execution of the worldwide regulatory strategy for all investigational and marketed products in the Oncology and Inflammation Therapeutic Areas.

The VP will also be responsible for the definition and execution of precision medicine across the portfolio providing leadership to the precision medicine team within regulatory.

Join us to help us realize our vision to deliver a broad variety of transformative indication approvals by 2030 that positively impact patient lives.

Working in close partnership with Therapeutic Area Leadership, Program Strategy Teams, Global Development Teams, and Global Regulatory Leads, this role will provide regulatory leadership and oversight to the development of global regulatory strategies, provide regulatory guidance, review critical impact documents for submission to regulatory authorities, and oversee the execution of the global regulatory strategy by the regions in line with the Program Strategy Team's goals for each of the products.

The VP will report to the SVP of Regulatory Affairs and Development Sustainability and lead in a cross-functional and multi-cultural environment and leverage their extensive experience to represent Regulatory Affairs in discussions with senior leadership and Executive Management.

The VP will lead and mentor senior regulatory professionals within Oncology, Inflammation and Precision Medicine that serve as Franchise Heads as well as their designated Global Regulatory Leads and broader teams in support of innovative programs to address the unmet medical needs of patients.

The VP will be a member of the Regulatory Affairs Senior Leadership Team and as such will contribute to defining and executing the regulatory vision and managing the

organization.


Key Responsibilities:
Provide leadership and management to the global oncology and inflammation regulatory team to advance Gilead's portfolio of products through the lifecycle of development from phase I to phase IV in accordance with corporate objectives

Create a culture of excellence and innovation and inspires team members to be trailblazers and perform at their highest abilities.

Leverage deep oncology and/or inflammation regulatory experience to provide teams with strategic and technical guidance on innovative approaches informed by regulatory precedent and emergent opportunities for the global registration of therapeutics

Lead and advance the organizational structure, strategy and operations across global regulatory affairs to ensure the needs of Precision Medicine are proactively and fully incorporated into development programs for our innovative products

Recruit, retain, coach and mentor, motivate and develop talent

Develop and manage budget and resources

Track, measure, and evaluate performance and ensure continuous improvement performance.

Build, maintain and advance partnerships with key stakeholders across the Development, PDM and Commercial functions to advance near-term regulatory strategies and long-term vision

Dissect and distill complex key issues to provide strategic input to support regulatory team members in discussion with regulatory authorities and guide teams in the preparation of regulatory content

Represents global regulatory affairs at the highest technical review committee, the Development Review Committees (DRCs) and provides guidance and direction with impact to ensure robust product development plans

Fosters and enhances collaboration and co-ordination across Development, the Oncology, Inflammation and Biomarker Team and PDM.

Provides regulatory oversight, strategic and technical guidance in discussions with teams in support of due diligences for potential in-licensing activities, external collaborations and acquisitions

Member of the Global RA senior leadership team and as such will contribute to defining and executing the regulatory vision, roadmaps, initiatives and outcomes.

As a member of the RA SLT you will impact the continued development of the regulatory affairs department.

Acts as delegate for SVP Regulatory Affairs, as appropriate.

Ensures conduct of activities in full compliance of all laws, regulations, ICH requirements, regional requirements and scientific and company policies and SOPs.

Understands external landscape and evolving regulatory requirements impacting Gilead products

Represents Gilead and Regulatory Affairs at external meetings, as appropriate, to develop and influence regulatory policies

Envision new regulatory policies based on good regulatory science and engage with

health authorities, and other organizations (e.g. WHO, B&H Gates Foundation) worldwide to bring about change

Develop and champion high impact initiatives to advance regulatory vision

Develop impactful cross-functional solutions to enable access to Gilead's products in underserved communities around the globe through internal and external multi-stakeholder partnership

Establish an enabling environment as a role model for Gilead's core values, integrity, inclusion, teamwork, excellence and accountability.


Qualifications:
Science degree (PhD, PharmD, MD, MSc) with 15+ years of overall regulatory leadership experience, including leadership of global teams

Negotiation, influence and excellent interpersonal communication skills are required

Proven global leadership capability and deep understanding of the oncology and inflammation therapeutic area ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions; experience in the leadership to life-cycle management of products across oncology and/or inflammation therapeutic areas (list) highly desirable

Proven ability to represent Gilead in key negotiations with regulatory authorities in the US, EU, Japan, China, and across regions

Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues

Extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and understand current global and regional trends in regulatory affairs and ability to assess the impact of these requirements to the business

Proven negotiation skills

Proven capability for leading transformational activities to prepare the Company for major changes in legislation which impact across departments

Must be capable of critically reviewing complex technical documents and influencing colleagues across functions

Ability to skillfully navigate the executive matrix

Recognized as an expert resource for regulatory advice internally and externally

People Leader Accountabilities

Create Inclusion - knowing the business value of diverse teams, modelling 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, organizational objectives and holding them to account.

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

Gilead Core Values
Integrity (Doing What's Right)

Inclusion (Encouraging Diversity)

Teamwork (Working Together)

Excellence (Being Your Best)

Accountability (Taking Personal Responsibility)

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.


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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.

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