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@ Gilead
  • Post Date : May 12, 2024
  • Apply Before : Jun 12, 2024
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Job Detail

  • Offered Salary 0
  • Commitment Full Time
  • Compensation Paid
  • Required education level Bachelor’s degree

Job Description

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At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.

Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description

The Executive Director, Innovation, Digital, and External Partnerships within Gilead’s Global Regulatory Affairs (GRA) organization is accountable for direct leadership of digital strategies and innovative external partnerships aimed to drive regulatory business outcomes. The leader, and their respective team, has responsibilities across the GRA organization for digital enablement and information management capabilities, as well as engagement with external partners (e.g. regulators, consortia, trade groups, BPO, tech vendors) in the pursuit of new innovative approaches to enable regulatory processes.

This role partners across GRA, RSQ, and enterprise functions to Influence and guide leadership on new opportunities for enhanced digital and information management capabilities within their respective functions and works tirelessly to drive digital change. This leader will collaborate across the enterprise with leaders from Data Science, Clinical Science, Manufacturing, and Commercial to identify opportunities to improve outcomes, operational efficiencies, and quality across the E2E regulatory lifecycle. The leader partners with IT on identifying digital investments and optimizing operating models to drive efficiency and build future regulatory capabilities.

The role partners with Regulatory Policy to establish external partnerships that are focused on enabling digital transformation across the full lifecycle of Gilead’s medicines. Accountable for establishing and leading external IT focused partnerships/collaborations, including but not limited to, ICH, NIST, NAM, EMEA, FDA centers, trade organizations (eg. EFPI, BIO, PHARMA), foundations (e.g. Bill and Melinda Gates), and industry consortiums (e.g. DEEP, Transcelerate, DIME – Digital Medicine, CERSI) to improve the E2E regulatory process through digital transformation of the development and approval of effective medicines. The leader will also be accountable for ensuring Gilead’s Regulatory Affairs internal digital platforms are agile and adaptable to changes occurring in the external regulatory environment.

The role is accountable for creating an integrated ecosystem of innovation in GRA and across the E2E regulatory value chain. The leader will be accountable for nurturing a culture of creativity and enterprise thinking across GRA and broader organization to deliver innovative uses of process and digital to deliver value to Gilead. The leader will also be accountable for embedding an entrepreneurial mindset and approach across the value chain through the adoption of non-traditional approaches to how GRA / RSQ achieve our innovation aspirations.

S/he represents the GRA organization in internal and external forums on future digital and information management capabilities within regulatory affairs. The leader establishes and maintains engagement with external associations and industry forums to provide our organizational perspective, drive industry thought leadership, and gain external insights. As a leader of the team s/he creates an environment that attracts, develops, and retains high quality employees.

The Executive Director will report directly to the Vice President, Regulatory Affairs Innovation, Content, and Operations and will assume functional management of colleagues that currently report into the RIM team and any other ICO colleagues that are currently working in the digital space. The role will be responsible for resource management including employee new hire, retention activities, performance and rewards management, and succession planning. The role will also be accountable for mentoring and developing team members.

EXAMPLE RESPONSIBILITIES:

  • Establish and lead the innovation, digital, and external partnerships function and team, including leading other people leaders. Hires, develops, and retains diverse top talent on the team. Inspires and coaches a high functioning team across a variety of cultures and career interests.
  • Creates and maintains an integrated ecosystem of innovation and entrepreneurship that drives optimized outcomes for Regulatory Affairs
  • Serve as an innovation partner and thought leader to key partners such as Data Sciences, Clinical Science, Clinical Operations, Manufacturing, and Commercial.
  • Works as an integrator and connector both internally and externally to ensure Gilead’s regulatory systems are fit for purpose to support current and future evolution of the regulatory environment.
  • Ensures high ethical standards and a culture that values honesty, integrity, and transparency.
  • Directs the full lifecycle of regulatory digital solutions – defining business need, project planning, vendor selection, development, deployment, and end user adoption – and provide ongoing management and functional oversight for all clinical systems. Works in partnership with IT and QA on the planning and execution of a portfolio of projects.
  • Partners closely with the Regulatory Affairs Policy team on identifying, establishing, and maintaining external partnerships focused on the health authority space.
  • Responsible for implementation of regulatory changes at Gilead through technology adoption (e.g. CTIS, Digital Protocols (M11-M2)).
  • Accountable for establishing and leading external IT focused partnerships/collaborations, including but not limited to, ICH, NIST, NAM, EMEA, FDA centers, trade organizations (eg. EFPI, BIO, PHARMA), foundations (e.g. Bill and Melinda Gates), and industry consortiums (e.g. DEEP, Transcelerate, DIME – Digital Medicine, CERSI) to improve the E2E regulatory process through digital transformation of the development and approval of effective medicines.
  • Sets clear and elevating goals for the team and individual direct reports.
  • Develops, drives, and executes long term vision and strategy for Digital and Information Management capabilities for GRA based on business objectives.
  • Provides industry expertise and knowledge of current and emerging digital technologies and information management approaches for regulatory affairs and adjacent functions.
  • Partners with GRA leaders to see new opportunities for enhanced information management and digital capabilities (i.e. Robotic Process Automation, AI/ML).
  • Proactively identifies new capabilities and capability enhancements to our existing investments that will enhance regulatory business performance.
  • Integrates strategic sourcing into information management and digital capabilities where applicable.
  • Represents the GRA organization at both internal and external forums on digital and information management capabilities within regulatory affairs.
  • Establishes and manages budgets and resource plans for digital and information management strategic initiatives.
  • Ensures team’s work complies with established practices, policies, and processes and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

  • PharmD/PhD with 10+ years’ relevant experience.
  • MA/MS/MBA with 14+ years’ relevant experience.
  • BA/BS with 16+ years’ relevant experience.
  • 10+ years’ experience in leading digital/information management capabilities in regulatory affairs.
  • Extensive experience leading the development of a vision and roadmap for digital and information management capabilities within a global regulatory affairs organization.
  • Leadership experience with high complexity, cross-functional initiatives, including team and governance management, strategy setting, and effective oversight of strategy execution.
  • Extensive experience leading large global initiatives for changing operating constructs and digital/information management capabilities in regulatory affairs domain.
  • Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.
  • Extensive experience interacting with and presenting to executives and managing large-scale project budgets and resources.
  • Has multiple years of line management (direct reports) experience, including managing other people leaders (with indirect reports).

Knowledge & Other Requirements

  • Expert-level of knowledge of the biopharma industry, including in-depth understanding of other adjacent functions to regulatory (i.e. clinical, pharmacovigilance, quality, medical affairs), as evidenced by proven track record of leading organizations and teams to achieve strategic initiatives relating to digital capabilities.
  • Excellent knowledge of the external regulatory and digital environment including health authorities, consortia, trade groups, non-profits, and standards bodies.
  • Recognized as an expert in the digital and information management capabilities required to enable a global regulatory affairs organization.
  • In-depth knowledge of regulatory requirements and standards relating to digital and information management capabilities, including business system ownership and validation.
  • Demonstrates in-depth knowledge of current trends in regulatory affairs for digital enablement and is able to apply these emerging capabilities to improve business outcomes.
  • Proven ability to influence up, down, and across the organization and externally in a collaborative manner.
  • Strong executive presence with demonstrated influence through leadership both on digital/information management and broader organizational initiatives.
  • Exceptional interpersonal skills and understanding of team dynamics.
  • Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for execution. Demonstrated ability to align other leaders and garner their commitment and engagement to cross-functional strategies, plans, and strategic objectives.
  • Strong negotiation and conflict resolution skills.
  • Advanced coaching capabilities to mentor/develop staff.
  • When needed, ability to travel.

The salary range for this position is: $268,430.00 – $347,380.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.

For Additional Benefits Information, Visit:

https://www.gilead.com/careers/compensation-benefits-and-wellbeing

  • Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
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