Manager, Clinical Programming (EDC)

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

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. As a Manager, Clinical Programming (EDC) at Gilead you will have the following responsibilities:

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

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: $133,195.00 - $172,370.00. 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:

* 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 Sign up to follow @KitePharma on Twitter at

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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 for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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.

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