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The Director, Medical Affairs, US Real World Evidence Center of Excellence is responsible for leading Kite’s 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 team’s 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:
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.
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 system's ability to recognize and kill tumors. Kite is based in Santa Monica, CA. For more information on Kite, please visit www.kitepharma.com. Sign up to follow @KitePharma on Twitter at www.twitter.com/kitepharma.
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 disability, genetic 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 laws. In 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 ApplicantAccommodations@gilead.com for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
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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.
Please apply via the Internal Career Opportunities portal in Workday.