We’re 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. We’ve made incredible scientific breakthroughs and our pioneering personalized CAR T-cell therapies have changed the paradigm. But we're 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 As part of the Clinical Development Department, the Sr Clinical Development Scientist fills a key role (Clinical Scientist) on the clinical study team within one of Kite's cellular therapy programs. Working in close collaboration with the study medical monitor, the incumbent will provide scientific guidance and support to the team. He or she will be responsible for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings. Essential Duties and Job Functions: Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies. Acquires and utilizes knowledge of clinical trial design and relevant disease indications to assist with protocol development. Participates in discussions concerning scientific and procedural aspects of study design. Coordinates with other departments to produce the final protocol and informed consent documents. Contributes to the development of CRFs, edit checks, IVRS specifications, ongoing data cleaning (query generation, coding review, SAE reconciliation) and data trend analysis. Designs patient profiles and writes accompanying medical data review rules as directed by the medical monitor. Leads data cleaning effort in preparation for dose escalation or DSMB meetings, as applicable to study stage. Organizes and manages external medical advisory committees for the study team such Scientific Steering Committees, as directed by the medical monitor. Researches and summarizes scientific or technical information available in published literature for continual self-learning and to assist in preparing training, study manual, or investigator meeting materials. Participates in the review of statistical analysis plans, table, listing, figure design and presentations of study data. Addresses site questions regarding protocol and related scientific issues and attends site initiation visits (SIVs). Assists in reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents. Supports priorities within the functional area and contributes to department initiatives as requested. BASIC QUALIFICATIONS: BS/BA in biomedical field and 8 + years relevant scientific and/or drug development experience -OR- MS in biomedical field and 6+ years relevant scientific and/or drug development experience -OR- PhD or PharmD and 2+ years relevant scientific and/or drug development experience PREFERRED QUALIFICATIONS: Advanced degree (PharmD, PhD, MS, etc.). Ideally the candidate will have experience directly in the clinical science role, in a hematology/oncology indication, and on global phase 2 and 3 studies. Able to translate technical concepts into accessible language and direction for the broader study team. Flexible and adaptable to quickly changing priorities, and willingness to move between projects to provide support/expertise as business needs dictate. Experienced in Microsoft Office (Excel, Word, PowerPoint, OneNote), and ideally also with job related programs such as J-Review and Medidata Rave or similar. Strong understanding of ICH GCP, as well as general knowledge of industry practices and standards. Excellent interpersonal, organizational, written, and verbal communication skills. Ability to work effectively on teams with a combination of remote and office-based team members. Exemplify our core values of integrity, accountability, teamwork, excellence, and inclusion. People Leader Accountabilities: •Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams. •Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose. •Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem. The salary range for this position is: Other US Locations: $153,935.00 - $199,210.00. Bay Area: $169,320.00 - $219,120.00. Kite considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*. 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. For 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 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. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT 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.