Vice President, Global Regulatory Strategy Head, Virology

Employer
Gilead Sciences
Location
Belmont, CA
Closing date
Sep 26, 2021

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Sector
Science, Life Sciences, Microbiology/Virology, Pharmaceutical, Senior Management
Job Description
The Vice‐President 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), COVID‐19 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 COVID‐19 approved by the U.S. Food and Drug Administration (FDA).

The new Vice‐President 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 cross‐functional 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 cross‐functional 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 in‐licensing 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 life‐cycle management of products across Virology therapeutic areas is desirable

Advanced scientific degree (PhD, PharmD, MD, MSc) preferred

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