Vice President, Global Head of Patient Safety

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Job description

Vice President, Global Head of Patient Safety
United 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

For Current Gilead Employees and Contractors:

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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 Gilead Patient Safety organization is a dynamic organization of over 300 scientists and clinicians, with a worldwide footprint including core sites in Foster City CA, Cambridge UK and Parsippany NJ. The Patient Safety Leadership Team includes the VP Global Head to whom report four vice presidents and two executive directors, encompassing the therapeutic areas (virology, oncology, inflammation, established products) and related medical safety science activities, strategic operations and EU QPPV/Affiliates.

Reporting to the SVP of Regulatory, Safety and Quality (RSQ), the VP Global Head of Patient Safety (GHPS) is responsible and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all Gilead investigational and marketed products. The GHPS provides leadership, through the Patient Safety Leadership team, to a dynamic and global organization of over 300 scientists and clinicians. The GHPS leads broadly in a cross-functional and multi-cultural environment and leverage their experience to represent Patient Safety in discussions with senior leadership and Executive Management. The GHPS oversees patient safety governance processes and chairs the Global Safety and Labeling Committee. The GHPS is a member of the RSQ Leadership Team, the Extended Development Leadership Team and the Gilead Operating Group (top senior leaders).

Core Responsibilities:

Strategic Thinking: Sets the overall safety strategy for all of the Gilead portfolio throughout the entire product lifecycle with input from Research, Clinical Development, Regulatory Affairs, Quality, Pharmaceutical Development & Manufacturing, Legal and Commercial functions. Understands the competitive landscape across all therapeutic areas, including having a perspective on how clinical practice and patient needs are evolving as well as therapeutic area trends and their relevance to the Gilead portfolio; Provides pharmacovigilance leadership, oversight, strategic and technical guidance in discussions with teams in support of due diligences for potential in-licensing activities, external collaborations and acquisitions; ensures pharmacovigilance operations and organizational structure deliver optimally in terms of efficiency, quality and strategic contributions.

Influence & Partnership: Establishes and maintains strong, collaborative relationships with all relevant internal stakeholders; Establishes and maintains an external network including relationships with the pharmacovigilance community and innovation community, medical and scientific organizations, governmental bodies and patient organizations; Identifies opportunities and sources of innovation within pharmacovigilance; Sets the expectation for and models a collaborative and enterprise mindset.

Delivery Excellence: Ensures that the pharmacovigilance actions are aligned with disease area strategies and appropriate activities are prioritized; Facilitates efforts across Development and is accountable for the technical execution of pharmacovigilance projects and deliverables across all therapeutic areas; Oversees the safety related operational direction across all therapeutic area within the Development organization, which includes responsibility for medical safety aspects of clinical studies such as protocol design, benefit-risk assessment, signal detection and management, medical monitoring of post-authorization commitment safety studies, safety governance activities (e.g., EU QPPV) and local Patient Safety activities. Champions initiatives that contribute to global process improvements. Develops and provides mentorship to enable project teams to embrace pharmacovigilance initiatives and strategic remits.

Additional Responsibilities:

Innovation: Thinks creatively and brings innovative solutions to optimize the contribution of Patient Safety within Gilead; Identifies and leverages advances in pharmacovigilance where appropriate, such as use of artificial intelligence, real-world data, analytics and innovative trial designs to support operational efficiency, signal detection, risk management and enhanced benefit-risk profile

People Development: Develops others by creating opportunities within the PS organization, fostering cross-functional exchanges, identifying and mentoring high performers and building a culture of continuous improvement and inclusion throughout the organization; Delegates responsibility and empowers others.

• Maintains a culture of rigorous data-driven decision making that rewards truth-seeking behavior; Encourages employees to exercise good judgement and embrace decision making; Empowers capable individuals to be accountable decision-makers; Closely partners with senior leaders to develop strategies in close alignment with business objectives across the portfolio

Communication: Advocates on behalf of Gilead and effectively communicates complex medical/clinical concepts in both written and oral communication to both internal and external stakeholders

Basic Requirements

Capabilities & Requirements:

• Prior global leadership experience in a Patient Safety / Pharmacovigilance organization and broad R&D global functional experience and understanding
• Credibility and reputation to attract and retain top talent with a history of creating teams that can thrive in a fast-paced, matrixed environment.
• Ability to create and fulfill a vision in a matrix environment and work collaboratively with internal stakeholders across different functions.
• Strong interpersonal skills that facilitate collaboration across functions to reach consensus on safety topics.
• Ability to travel nationally and internationally as required.

Education & Qualifications:

• MD degree and board certification or equivalent years of pharmacovigilance experience
• 15+ years of biopharmaceutical industry drug development experience, early through late-stage development

Preferred Qualifications

Capabilities & Requirements:

• Established track record as a strong clinical scientist, with expertise in translational medicine, real-world evidence, benefit-risk assessment and risk management.
• Solid knowledge of pharmacovigilance operations and processes as well as national/regional differences and requirements (e.g., US FDA, EMA, PMDA)
• Established reputation as a senior leader in the global pharmacovigilance ecosystem (e.g., participation in CIOMS, Navitas, Transcelerate
• Established reputation as a leader of a senior level team with a global footprint, managing across time zones and geographies.

Education & Qualifications:

• Additional degree or hands-on training in epidemiology, biostatistics or related fields
• Broad career experience including academic medicine and industry experience in development, medical affairs and/or regulatory affairs.

Gilead Core Values

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