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VP, Head of Global Regulatory Affairs Oncology & Inflammation, and Head of Sustainability

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Nov 27, 2022

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Job Details

VP, Head of Global Regulatory Affairs Oncology & Inflammation, and Head of Sustainability
United States - New Jersey - Morris PlainsUnited 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

For Current Gilead Employees and Contractors:

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

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.

Description:

The Head of Global Regulatory Affairs Oncology & Inflammation will be responsible and accountable for the definition and execution of the worldwide regulatory strategy for all investigational and marketed products and diagnostics in the Oncology and Inflammation Therapeutic Areas including an extensive pipeline of assets in development. 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 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 and Inflammation 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 with a broad variety of solid and liquid tumors.

This VP within the Development Organization will also lead and advance the vision for sustainability goals and programs. Our legacy and ambition is to reach patients around the world with our products and solutions. This position will take on an important leadership role to ensure that sustainable solutions are build into our development programs across all therapeutic areas at Gilead to facilitate broader access for patients in need. This work will include collaboration with senior leadership within Development and other functions in support of our access programs at Gilead. The Global Regulatory Policy and Intelligence Group will also report to this position.

Responsibilities & Skills:
  • Proven experience in leading global development and regulatory teams to advance multiple programs and indications in the oncology therapeutic area
  • Ability to leverage deep oncology regulatory experience to provide teams with guidance on innovative approaches informed by regulatory precedent and emergent opportunities for the global registration of therapeutics and diagnostics
  • 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 Oncology and Inflammation TAs
  • Lead and advance the organizational structure 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
  • 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 Oncology and Inflammation 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 Oncology and Inflammation TAs
  • 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 Oncology and Inflammation Development Review Committees (DRCs) 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 and their central Regional Regulatory teams based in the US and UK that are responsible for all INDs, CTAs, BLAs, NDAs, MAAs and life cycle management within the Oncology and Inflammation TAs; plans resources and coordinates regulatory activities and communications across the global regulatory matrix
  • Leads Global Regulatory Leads/Strategists for diagnostics to develop global regulatory strategies for the development and registration of diagnostics by partner companies, as well as clinical trial approvals for studies utilizing diagnostic tests
  • Responsible for leading all regulatory activities for assigned projects in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  • Represents Gilead and Regulatory Affairs at external meetings to develop and influence regulatory policies in designated areas of accountability
  • 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
  • In collaboration with internal and external stakeholders, identify key priority areas for the sustainability strategic plan aligned with Gilead's pipeline and corporate ESG goals and the corresponding cross-functional strategy to address global healthcare disparities within prioritized areas
  • Develop impactful cross-functional solutions to enable access to Gilead's products in underserved communities around the globe through internal and external multi‑stakeholder partnerships
  • Partner with internal stakeholders including Development, Global Patient Solutions, and Government Affairs & Policy, to develop aligned strategies for discussion with external partners in the global public health ecosystem including governments, non-governmental organizations, academia, industry partners and non-profit organizations on strategic public health priorities to create sustainable models of equitable health care in low and middle income communities around the globe
  • In collaboration with leaders within Development and other functions, ensure drug development programs include plans to address clinical trial diversity, patient access to clinical trials, global disease burden and equitable access to Gilead's products in both developed and developing countries
  • Establish standard processes, KPIs and organizational structure to support the cross-functional sustainability strategic plan


Minimum 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
  • Demonstrated global leadership capability and deep understanding of the oncology therapeutic area, and the preferably the inflammation therapeutic areas, 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 therapeutic areas (list) highly desirable


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

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 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., Canada, Australia, Singapore, and Hong Kong 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.​

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT

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.

For Current Gilead Employees and Contractors:


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






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Company

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. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
 

Find Us
Website
Location
333 Lakeside Drive
Foster City
California
94404
US
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