VP Global Patient Safety & Global Safety Therapeutic Area Head - Oncology (United States - California - Foster City)

This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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.

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-19and 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.  

Position Overview:  

The   VP Global Patient Safety & Global Safety Therapeutic Area Head  - Oncology will be responsible and accountable for the definition and execution of the worldwide pharmacovigilance strategy for all investigational and marketed products in their Gilead Therapeutic Area. The VP will lead broadly in a cross-functional and multi-cultural environment and   leverage   extensive scientific and pharmacovigilance experience to   represent   Global Patient Safety in discussions with senior leadership, Executive Management and regulatory authorities and lead benefit/risk efforts for the specific therapeutic area across the company.  

Key Responsibilities:  

• Strategic Thinking: Set   the overall safety strategy for a specific therapeutic area within Global Patient Safety with input from Research, Clinical Research, Medical Affairs, Regulatory Affairs, Legal and Commercial functions. Understands the competitive landscape within the therapeutic area, 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 oversight, strategic and technical guidance in discussions with teams in support of due diligences for potential in-licensing activities, external collaborations and acquisitions. Offers scientific oversight in assessment of   benefit /risk profile of all Gilead products within a therapeutic area.  

• Influence and Partnership : Establish and maintain strong, collaborative relationships with Research, Development, Business Development, and Commercial stakeholders; Establish and maintain an external network including relationships with the innovation community, medical and scientific organizations, governmental bodies and patient organizations; Leads benefit/risk discussions and decision making for the specific therapeutic area in a collaborative and cross-functional manner involving Clinical, Commercial, and other functions within Gilead.   Identifies   opportunities and sources of innovation within pharmacovigilance; Sets the expectation for and models a collaborative and enterprise mindset.  

• Delivery Excellence : Strives for continuous education and awareness of the organization on any relevant benefit/risk developments for the specific therapeutic area; Ensures that 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 within the safety therapeutic area.; Owns the operational direction for the specific safety 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   and  medical   monitoring of post-authorization studies.  Champions initiatives that contribute to global process improvements.   Develops   teams and   provides   mentorship to enable project teams to embrace pharmacovigilance initiatives and strategic remits.  

• Innovation:   Thinks creatively and brings innovative solutions to the therapeutic area;   Identifies   and leverages advances in pharmacovigilance where   appropriate , such as use of real-world data, analytics, and innovative trial designs to support signal detection and management  

• People Development: Develops others by   identifying   and mentoring high performers and building a culture of inclusion and collaboration throughout the organization; Delegates responsibility and empowers others  

• Decision-making:   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 other senior leaders to develop strategies in close alignment with business   objectives   across the therapeutic area  

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

Qualifications:  

• MD or equivalent medical degree  

• Board certification preferred or equivalent years of pharmacovigilance experience in Oncology therapeutic area  

• 15+ years of global biopharmaceutical drug development and pharmacovigilance experience over the entire product lifecycle  

• Extensive pharmacovigilance experience in a global environment  

• Prior leadership experience in a safety therapeutic area and broad R&D global functional experience and understanding  

• Credibility and reputation to attract and   ret]]>