Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site (https://www.myworkday.com/gilead/d/inst/13102!CK5mGhIKBggDEMenAhIICgYI1A0QtgI~/cacheable-task/2997$2151.htmld#backheader=true) to apply for this job.Job DescriptionPosition Description:
The Executive Director and Global Regulatory Strategy Head of Inflammation will oversee and be accountable for the definition and execution of the worldwide regulatory strategy for all development programs in the Inflammation therapeutic area including, but not limited to, rheumatoid arthritis, inflammatory bowel diseases (Ulcerative Colitis, Crohns Disease), SLE, and fibrotic diseases (PSC, NASH). This position will represent the inflammation therapeutic area on the Regulatory Affairs Senior Leadership Team, Development Review Committee, and report directly 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 bulevirtide (Hepcludex) 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 Veklury (remdesivir), the first treatment for COVID-19 approved by the U.S. Food and Drug Administration (FDA).
The Executive Director will lead our talented regulatory professionals as we now continue our quest to innovate for people living with inflammatory 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 across the regions (e.g. US, EU, China and Japan) in line with the Program Strategy Teams goals. The Executive Director will lead broadly in a crossfunctional and multi-cultural environment and leverage their extensive experience to represent regulatory affairs in discussions with senior leadership and Executive Management. This position will lead and mentor senior leader regulatory professionals that serve as global and regional regulatory leads in support of our growing pipeline of innovative products in the inflammation therapeutic area.Key Responsibilities:
- Proven experience in leading global regulatory teams to advance the development and registration of multiple programs in Inflammation or other relevant therapeutic area (TA)
- Ability to leverage deep regulatory experience in working with therapeutics for inflammatory disease, 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 to address unmet medical needs
- 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 Inflammation TA
- Proven ability to represent the sponsor in key negotiations with regulatory authorities in one or more region including the US, EU, China and Japan
- 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 Inflammation Clinical Research, in addition to crossfunctional teams within Development and Commercial functions, to develop regulatory strategies in close alignment with business objectives across the Inflammation 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 Inflammation 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 lifecycle management within Inflammation 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
For jobs in the United States:
- PhD/Master's Degree with 14+ 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 inflammation therapeutic area
- Advanced scientific degree (PhD, PharmD, MD, MSc) preferred
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