VP, Global Regulatory Strategy Head, Virology

VP, Global Regulatory Strategy Head, Virology
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. 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 #CreatingPossible

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The VicePresident and Global Regulatory Strategy Head for Virology is a key new leadership position that will oversee and be accountable for the definition and execution of the worldwide regulatory strategy for all investigational and
marketed products in the Virology Therapeutic Area; this includes HIV, Hepatitis (B, C & D), COVID19 and other emerging viruses. This position will represent the Virology therapeutic area on the Regulatory Affairs Senior Leadership Team, Development Review Committee, and report to the SVP of Regulatory Affairs.

Gilead has pioneered more than 25 products since our founding in 1987, including the first single tablet regimen (STR) to treat HIV and the first medicine to prevent acquisition of HIV. We subsequently have introduced multiple STRs to address the needs of people living with HIV around the world. Gilead has also developed products for the treatment of Hepatitis
B, curative therapies for hepatitis C, and recently acquired asset which is approved in the European Community for the treatment of chronic hepatitis D. Our deep antiviral experience, paired with our commitment to treating global health crises, helped us rapidly advance and deliver the first treatment for COVID19 approved by the U.S. Food and Drug Administration (FDA).

The new VicePresident will lead our talented regulatory professionals as we now continue our quest to innovate for people living with HIV and other viral diseases with unmet medical needs. Working with the 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 lead broadly in a crossfunctional and multicultural 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 leader regulatory professionals across the Virology portfolio that serve as the designated Global Regulatory Leads and their teams in support of designated
programs to address the unmet medical needs of the patients in need of innovative new antiviral medicinal products.

Key Responsibilities:

• Proven experience in leading global regulatory teams to advance the development and registration of multiple programs in Virology or other relevant therapeutic areas
• Ability to leverage deep regulatory experience in working with antiviral therapeutics or other agents to provide teams with guidance on innovative approaches informed by regulatory precedent and emergent opportunities
• Experience in the preparation and submission of BLA/NDA/MAAs for submission within expedited timelines across the regions
• Proven ability to dissect complex issues to quickly distill key issues for discussion with regulatory authorities and guide teams in the preparation of responses to regulatory questions
• Ensures close alignment between the global regulatory strategy and corporate objectives within the Virology TA
• Proven ability to represent the sponsor in key negotiations with regulatory authorities in the US, EU, Japan, China and across regions
• Provides strategic and technical guidance on critical impact regulatory submissions (e.g. responses to major objections raised by regulatory authorities including product labeling)
• Develops and mentors teams to provide project teams with strategic regulatory guidance to expedite product development, registration and through life cycle management
• Impacts continued development of regulatory affairs department through leadership and participation on the Global RA Senior Leadership Team
• Ability to partner closely with senior leaders within Virology Clinical Research, in addition to crossfunctional teams within Development and Commercial functions, to develop regulatory strategies in close alignment with
• business objectives across the Virology TA
• Strong interpersonal skills that facilitate collaboration across functions to identify business solutions on regulatory issues
• Works through Global Regulatory Leads to partner ensure alignment in the definition and execution of regulatory strategy across the regions
• Represents global regulatory affairs at the Virology Development Review Committee (DRC) and provides guidance and direction with impact
• Provides regulatory oversight, strategic and technical guidance in discussions with teams in support of due diligences for potential inlicensing activities, external collaborations and acquisitions
• Leads Global Regulatory Leads, US and Central Regional Regulatory teams responsible for all INDs, NDAs and life cycle management within Virology TA; plans resources and coordinates regulatory activities and
• communications across the global regulatory matrix
• Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures.
• Maintains knowledge of highly complex regulatory requirements up to current date, while influencing preparation of new regulatory guidance wherever possible
• Champions initiatives that contribute to global process improvements which have a significant impact on business
• Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements and have an understanding of current global and regional trends in regulatory affairs and ability to
• assess the impact of these requirements to the business
• Must be capable of playing the lead role in updating and preparing 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
• Is recognized as an expert resource for regulatory advice internally and externally

Qualifications:

• 15+ years of overall regulatory leadership experience, including leadership of global teams
• Negotiation, influence and excellent interpersonal communication skills are required
• Demonstrated global leadership capability, ideally gained through regulatory leadership of multiple global development programs and NDA/MAA submissions
• Deep understanding of therapeutic agents in the Virology therapeutic area
• Experience in the leadership and lifecycle management of products across Virology therapeutic areas is desirable
• Advanced scientific degree (PhD, PharmD, MD, MSc) preferred

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 more information about equal employment opportunity protections, please view the EEO is the Law poster.
We are an equal opportunity employer. Apply online today at www.gilead.com/careers

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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 opens new window" target="_blank" href="https://apptrkr.com/get_redirect.php?id=2467365&targetURL=mailto:careers@gilead.com">careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. "Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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