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.
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.
The Associate Director, CDM will be responsible for overseeing all aspects of clinical data management for Kite’s 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:
Bachelor’s degree and 10 years of experience
Master’s 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 - 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.
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.