Director, US Real World Evidence Center of Excellence

Were here for one reason and one reason only to cure cancer. Every moment is dedicated to developing treatments and every action moves us one step closer to our goal. Weve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But were not finished yet.

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Job Description

The Director Medical Affairs US Real World Evidence Center of Excellence is responsible for leading Kites evidence generation strategy and execution in several key areas: (1) post-marketing requirement (PMR) registries for the US and countries with similar registry systems (2) epidemiological expertise to support pipeline planning as well as US safety and pharmacovigilance activities (3) development of strategically aligned scientific publications using real-world evidence (RWE) and (4) leadership of specialized analyses of real-world data including registries claims and electronic health records to support RWE studies.

The Director manages a team of epidemiologists and data analysts engaged in RWE studies. The role also entails collaboration with the cross-functional team including Clinical Medical Safety Commercial Research and Technical Operations to identify and lead strategically aligned projects where RWE can support organizational objectives including regulatory and technical initiatives pipeline acceleration and patient access. The Director will also serve as a leader of RWE in scientific forums and collaborate with external physicians scientists and researchers as well as alliance partners on RWE activities.

Specific duties include:

• Leading study concept development and execution of incidence/prevalence burden of illness and natural history of disease assessment for business and development and early development indications

• Strategic and tactical support for cross-functional RWE development including registries burden of illness/natural history of disease for regulators payers and clinicians

• Providing leadership and oversight of non-interventional study protocols regulatory documents and scientific publications

• Provide excellent people leadership to team members including fostering a candid constructive feedback culture cultivating the teams development and identifying and investing in succession planning

• Adapt performance metrics and dashboards for RWE projects to quantify and enhance impact

• Provide expertise on RWE and observational research to cross functional teams including brand strategy teams for assigned brand/pipeline newly launched and marketed product(s)

• Assess research gaps and objectives across key partners and disease areas to determine proactive RWE/observational research strategy

• Possess superb communication skills with adaptability to address technical and non-technical audiences and comprehensive understanding of strategies to translate observational research methods and results for patient benefit

• Effectively manage internal and external stakeholder expectations regarding strategic objectives and execution of research

• Provide RWE expertise and input for regulatory filings (e.g. BLA sBLA MAA) as well as response to questions from regulatory authorities in the context of IND submissions clinical trial applications filing procedures or pharmacovigilance/safety inquiries.

• Develop execute and deploy integrated evidence generation plans develop contingency plans provide technical and strategic advice and meet milestones and budgets

• Provide RWE leadership in scientific forums and interact with clinical investigators and thought leaders external stakeholders (medical experts advisory boards patient advocacy groups) and internal stakeholders (Research Translational Sciences Clinical Operations Safety Regulatory Medical Affairs and Commercial)

For additional benefits information visit:

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

Kite is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune systems ability to recognize and kill tumors. Kite is based in Santa Monica CA. For more information on Kite please visit . Sign up to follow @KitePharma on Twitter at jobs in the United States:

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