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
Responsibilities (include but are not limited to):
May have direct responsibility for supervising and training clinical programmers in the performance of their duties
Management of programming deliverables in coordination with internal and external cross functional teams
Perform the execution of programming activities (eCRF and EDC database, integrations, and module connections) for multiple studies of increased complexity and across indications/therapeutic areas
Provide input into the SOW activities for vendors
Perform the development and maintenance (migration) of eCRF and EDC database, integrations (e.g., IxRS) and module connections (e.g., Safety Gateway Configuration) based on the protocol and Kite standards
Oversee creation of operational metadata (including CRF and external) ensuring compliant to Kite standards
Provide oversight for programming activities which are outsourced to a CRO/Vendor
Ensure across studies consistency and adherence to standards and governance
Support Data Review activities (e.g., Review Data Review Plan, develop reporting tool reports, validate reports)
Perform support of snapshot, database lock activities and deliverables restriction
Develop, assess, and monitor project priorities/timelines for programming deliverables
Participate in study team meetings and provide technical expertise with database and reporting applications (e.g., EDC, Tableau, J-Review, Business Objects) and support as needed
Routinely interface with cross-functional team members
Ensure that SOPs are properly followed, and documentation is available
Align with EDC vendor regarding system updates, EDC platform integrations, and issue resolution
Ensure following programming best practices
Resolve problems as they arise within defined procedures and escalate, if necessary, at appropriate time
Represent as internal team leader who decides best course of action
Participate in CDM, Programming and cross-functional initiatives
Participate for programming activities during internal audits as well as Health Authority audits
Align with the department and company strategy and model
Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
Prioritize and delegate, if applicable, effectively study and initiative responsibilities
Prepare for expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
Work collaboratively with Programming (Clinical and Statistical) Clinical Operations, Biostatistics and others study team members to meet project deliverables and timelines.
Build networks to achieve influence with other functions and represent as Programming technical expert
Participate in department and/or cross-functional process improvement initiatives as well as special projects and create efficiencies within programming processes
Participate in review, approve and train on department procedures including SOPs and Working Practices
Actively Participate in programming team meetings when appropriate
Basic Qualifications:
MS/MA in life sciences or related discipline and 4+ years of experience in Clinical Programming OR
BS/BA in life science or related discipline and 6+ years of experience in Clinical Programming OR
Preferred Qualifications:
Technical experience in clinical development
Good understanding of regulatory, industry, and technology standards and requirements
Demonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
Experience with Medidata RAVE including database build, edit check programming, data extraction, migrations
Understanding of data standards (CDISC, CDASH) in the clinical trial environment
Experience with SAS programming (recommended)
Experience with Spotfire and/or J-Review programming (recommended)
Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
Demonstrate ability to work in a team environment with clinical team members
Good planning and project management skills as well as vendor management
Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
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.
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.
Please apply via the Internal Career Opportunities portal in Workday.