Director, Regulatory Affairs

Director, Regulatory Affairs
United States - California - Foster CityUnited States - New Jersey - Morris PlainsUnited States - Washington - Seattle

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.

At Gilead we believe every employee deserves a great leader. As a people leader now or in the future, we expect that you will model and create an environment of inclusion, be intentionally focused on the hiring, development, growth and retention of talent, and empower teams to align and achieve goals.
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 Virology, Oncology and Inflammatory Diseases. Our portfolio of more than 25 marketed products includes innovative complete treatment regimens for chronic hepatitis C infection, chronic hepatitis B infection and HIV in once-daily single pills in our Virology portfolio. Our Oncology portfolio 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, and two CAR T therapies approved for the treatment of adult patients with certain B cell lymphomas or Mantle Cell Lymphoma. 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.

Meet Some Gilead Employees:

https://www.gilead.com/careers/meet-our-employees?page=6

Gilead has established employee resource groups to support diversity and inclusion and provides a competitive benefit package including flexible work options and exceptional support for the family and the individual.

www.gilead.com

The Role:

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your scientific insight to partner with internal teams and external partners as we strive to cure unmet medical needs?

We have an exciting and unique opportunity for a senior Regulatory Professional to join our dynamic team at the Director level. You will lead a regulatory team in the development and execution of the global regulatory strategy for our HBV Cure program. This will be accomplished by you developing, communication and leading the global regulatory strategy across various cross functional teams, leading the regulatory project team, collating regional strategies/input, and articulating global regulatory strategy in governance meetings.

The Director will be site based at one of our locations in the US including Foster City, CA; Seattle, WA or Morris Planes, NJ. following our G Flex program that allows for up to three days work from home as appropriate and will report to the Executive Director, Regulatory Affairs.

Key Responsibilities:

• Accountable for the successful oversight and completion of a broad spectrum of regulatory activities and deliverables for typically a portfolio of products, compounds, indications and/or other projects in the virology therapeutic area.
  
  • Specifically, accountable and responsible for the development and execution of the global HBV Cure regulatory strategy through leadership and oversight of global regulatory team which includes global and regional regulatory liaisons, product labeling leads, medical writers, advertising and promotion leads, project managers and regulatory operations publishing leads.
    
• Responsible for leading all regulatory activities for assigned project(s) and territories in line with ICH requirements, regional requirements and scientific and company policies and procedures.
  
• Responsible for development, oversight and communication of global and regional (as applicable) regulatory strategy for assigned projects and regions.
  
• Provides matrix management and leadership to multiple or larger-scale projects and teams.
  
• Oversees contacts for local Regulatory Authorities.
  
• Advises other functions on short- and long-range regulatory strategies, plans, resources and tactics in cross functional meetings as the global regulatory representative such as the program strategy team and global development team.
  
• Works on extremely complex problems and provides solutions that have significant impact.
  
• Influences the long-term strategy of the virology therapeutic area.
  
• May have one or more direct reports. May lead other people leaders.
  
• May participate in and play a more active role in Virology therapeutic area Regulatory short- and long-range budget and resource plan development and management.
  
• Typically plays a lead role in special projects, such as continuous improvement and optimization initiatives with potential impact across Global Regulatory Affairs.
  
• Serves as a spokesperson for Regulatory Affairs on significant matters relating to policies, programs, capabilities, and long-term goals and objectives.
  
• Recognized as a key representative for the conduct and oversight of regulatory activities for a broad portfolio of products and/or projects.
  
• Represents Gilead at external professional meetings or discussions with industry trade groups.
  

How We Expect you to Work:

• Routinely advises other colleagues on ways to better demonstrate and uphold our Leadership Commitments and Values.
  
• Able to extract added value and improved results by increasing standards and expectations across projects and teams.
  
• Independently determines how to structure and approach complex and often large-scale projects and other work to ensure strategic objectives are met or exceeded within the targeted timelines and resource parameters.
  
• Looks for ways to put the least pressure on resources to achieve the targeted results.
  
• Able to effectively represent complex and often high-profile projects to senior leaders and executives.
  
• Adept at distilling complex matters into a clear and elevating business case and roadmap for execution.
  
• Plays a lead role in significant change efforts as part of the complex projects or other work managed.
  
• Plays the lead role in advising project and business leaders on how to proactively incorporate change management into large-scale projects and initiatives to ensure ultimate success.
  
• Works effectively across a broader and more senior set of stakeholders.
  
• Models effective stakeholder management for other team members to follow.
  
• Ensures other team members adopt and maintain proactive and strong stakeholder management for the overall success of their work.
  
• Identifies, recommends and may lead strategic efforts to innovate or otherwise significantly improve outcomes for complex projects or other work.
  

Education, Knowledge and Other Experience:

• 12+ years of experience in Regulatory Affairs or other relevant industry experience with BS/BA
  
• 10+ years of experience in Regulatory Affairs or other relevant industry experience with MA/MS/MBA
  
• 8+ years of experience in Regulatory Affairs or other relevant industry experience with PharmD/PhD
  

BA/BS or advanced degree in life sciences or related field is preferred with extensive experience in the biopharma industry, including extensive experience working in regulatory or a related discipline. Significant experience setting the regulatory strategy and leading a broad range of regulatory activities for biopharmaceutical products including:

• Excellent verbal, written, negotiation and interpersonal communication skills are required
  
• Must be capable of developing and implementing regulatory strategy and of managing complex negotiations with Health Authorities.
  
• Must have an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories 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.
  
• Recognized as a regulatory expert in and outside of Global Regulatory Affairs.
  
• Expert knowledge of the drug development process, global and regional regulatory requirements for medicinal products.
  
• Expert knowledge of all key functions involved in the various stages of drug development from early research through post-marketing.
  
• Demonstrates strong leadership skills, as evidenced by past successes effectively setting short- and long-term team and project direction and leading projects and teams through successful execution.
  
• Develops solutions to a wide range of complex problems which require regular use of ingenuity, creativity and innovation; ensuring solutions are consistent with Global Regulatory Affairs and broader Gilead objectives and processes.
  
• Extensive regulatory, quality, compliance or related experience in the biopharma industry, including extensive experience negotiating with global Health Authorities at a senior decision-maker level.
  
• Extensive experience and significant successes setting and directing the regulatory or related strategy to successful conclusion for multiple products.
  
• Extensive experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
  
• Proven abilities to work independently, establishing work priorities and direction, make significant contributions to strategic planning and lead process improvements, as evidenced by past successes effectively managing increasing scope and complexity.
  
• Proven track record of effective people leadership and management, as evidenced through past effectiveness with employee engagement, development and retention either with direct reports or through matrix leadership responsibilities.
  
• Proven track record of successfully managing large scale, complex, time-sensitive projects.
  
• Experience working across varying stages of drug development is strongly preferred.
  
• Line management (direct reports) experience is strongly preferred.
  
• Experience developing drug products classified as GMOs is a plus.
  

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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.

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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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