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

Company: myGwork
Location: Lakeside
Posted on: August 6, 2022

Job Description:

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 including Trodelvy, magrolimab and 20 pipeline assets in development.

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, and Singapore 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.
      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. This employer is a corporate member of
      myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals,
      students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, San Diego , VP, Global Regulatory Strategy Oncology (NJ or CA, preferred), Healthcare , Lakeside, California

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