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VP, Global Regulatory Strategy Oncology (CA preferred, or NJ)

Employer
Gilead Sciences, Inc.
Location
Foster City, CA
Start date
Aug 29, 2022

View more

Discipline
Marketing, Regulatory, Science/R&D, Oncology
Required Education
Masters Degree/MBA
Position Type
Full time
Hotbed
Biotech Bay, Best Places to Work

Job Details

VP, Global Regulatory Strategy Oncology (CA preferred, or NJ)
United States - California - Foster CityUnited States - New Jersey - Morris Plains

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

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 to apply for this job.

Job Description
VP, Global Regulatory Strategy, Oncology

Overview:

Reporting to the SVP of Global Regulatory Affairs, and located in our Foster City, CA headquarters (preferred) or in our NJ site, the VP and Oncology Regulatory Strategy Head will be accountable for defining and executing of the worldwide regulatory strategy for all investigational and marketed products in the Oncology Therapeutic Area.

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

This VP will lead broadly 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. You will also lead and mentor senior leader regulatory professionals across the Oncology 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 therapeutic approaches for the treatment of a variety of solid and liquid tumors.

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
  • Experience in the preparation and submission of 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 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 Oncology 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 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 Oncology 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 and their US Regional Regulatory teams responsible for all INDs, NDAs and life‑cycle management within Oncology 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 the current date, while influencing the preparation of new regulatory guidance wherever possible.
  • Champions initiatives that contribute to global process improvements which have a significant impact on business.
  • Must have 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 the ability to assess the impact of these requirements on 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 Oncology expert resource for regulatory advice internally and externally.


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, 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.



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 'EEO is the Law' 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.
 

Company info
Website
Location
333 Lakeside Drive
Foster City
California
94404
United States

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