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.
Join Kite as we make even bigger advances in cancer therapies and help shape where our business and medical science goes next.
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 Kite and help create more tomorrows.
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:
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:
Kite Pharma is committed to providing equal employment opportunities to all employees and applicants for employment and is dedicated to fostering an inclusive work environment comprised of diverse perspectives backgrounds and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin sex age sexual orientation physical or mental disabilitygenetic 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 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 for assistance.
For more information about equal employment opportunity protections please view the Know Your Rights poster.
Kite Pharma will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
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.
Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
For Current Kite Pharma Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Director
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