Associate Director, Clinical Data Management

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

AtGileadour 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 worlds 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.

The Associate Director CDM will be responsible for overseeing all aspects of clinical data management for Kites clinical development programs with guidance from the Executive Director CDM. This position will be responsible for managing Data Managers (DM) CDM vendors project timelines working with Programming to create data quality reports clinical data collection working with the Standards function to develop and ensure compliance with eCRF standards and data review. The Associate Director CDM will also work with Clinical Operations Safety and Regulatory as necessary.

Responsibilities will include but are not limited to the following:

• Project level coordination and day to day oversight of Data Management tasks in the study lifecycle and estimating resourcing needs

• Mentor and provide guidance to Data Managers under their leadership

• Provide CDM expertise for database set up CRF design and data cleaning to efficiently ensure high quality data

• Manage vendors and ensure appropriate resources are available to meet the demands of the assigned clinical trials

• Effectively represent Data Management departments at study team meetings and other leadership meetings

• Manage CDM deliverables in coordination with internal and external cross functional teams.

• Collaborate with Standards on the development of Standards (e.g. eCRF reporting) and ensure data management compliance

• Collaborate with Programming to create internal data quality checks in support of Data Review on an ongoing basis to ensure quality data

• Lead Data Management process and technology improvement projects

• Provide guidance to study teams and external vendors regarding the technical aspects of clinical database structure

• Work closely with Quality and Compliance to ensure quality and continuous process improvement in clinical trial data management

• Represents data management activities for regulatory audits

• Project and personnel management skills and organizational skills

Basic Qualifications:

• Bachelors degree and 10 years of experience

• Masters degree and 8 years of experience

• PhD degree and 5 years of experience

Preferred Qualifications:

• Preferred 3-5 of years of experience in oncology therapeutic area

• Cellular therapy in oncology experience a plus

• Proficiency with MS Office Suite

• Ability to identify issues and seek solutions

• Ability to work both independently and collaboratively

• Ability in cross functional teams in fast pace dynamic team setting

• Efficient organized and able to handle short timelines in a fast-paced environment

• Experience and/or interest in the Biotechnology Pharmaceutical or health-care industry

• Knowledge and understanding of Good Manufacturing Practices (GMP) and regulatory policies

• Experience in clinical trial database build case report form design and familiar with CDISC and regulatory requirements Excellent oral and written communication skills

• Demonstrated knowledge of FDA EMA ICH guidelines and regulations covering clinical trials Biostatistics and data management

• Experience with CDISC standards (e.g. CDASH SDTM)

• Experience managing clinical data management deliverables for regulatory filings

• Experience with Reporting tools (e.g. Spotfire Jreview)

• Experience managing vendors (e.g. external CRO)

• Flexible to changing priorities detail-oriented works well under pressure and able to take on unfamiliar tasks.

• Experience with Medidata RAVE including database build edit check programming and data extraction

• Experience in oncology therapeutic area; cellular therapy in oncology experience

People Leader Accountabilities:

• Create Inclusion -knowingthe 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 employeesare receivingthe feedback and insight needed to growdevelopand realize their purpose.

• Empower Teams - connect the team to the organization by aligning goals purpose and organizationalobjectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

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 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 theKnow Your Rights poster.

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Kite Pharma provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

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