Gilead Sciences
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
Senior Manager, Clinical Data Management (CDM) is primarily an oversight role, working cross-functionally with internal and external partners to support our efforts in this fast-growing and important area of cell therapy. The role will report to the Associate Director, CDM or higher.
The Senior Manager, CDM will be responsible for leading and overseeing all aspects of clinical data management for Kite sponsored Non-Interventional Studies (NIS) and provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed, with guidance from the Associate Director, CDM or Director, CDM. The Senior Manager, CDM will be the lead representative working with cross-functional teams such as Clinical Operations, Translational Medicine, Safety, Biometrics, Clinical Development, Medical Affairs, and Regulatory, as necessary.
This position may be responsible for managing data managers and data management associates, overseeing CDM vendors (external and/or CRO), overseeing the creation of project timelines and data management documentation to ensure effective study delivery across the program.
Responsibilities (include but are not limited to):
Drive and execute the management of CDM deliverables within the Kite sponsored NIS program (including Post-Marketing Required (PMR) studies and Expanded Access Programs (EAP)), in coordination with internal and external cross-functional teams
Provide support and expertise on non-Kite sponsored collaborative and Investigator Sponsored Research (ISR), where needed
Contribute to defining the Kite CDM strategy and processes for these types of studies
Build strong working relationships with Clinical Operations, Medical Affairs, and Translational Medicine to understand upcoming study requirements and provide effective study oversight
Recognizing the effects of study-level decisions at the Program Level and proactively communicating to the wider study team
Provide functional area expertise and guidance during study initiation and conduct, including during protocol design and input into operating model expectations
Communicate efficiently with the CRO counterpart (as needed) to define expectations, set DM timelines and oversee the study status and activities
Works collaboratively with Clinical and Statistical Programming, Clinical Operations, Medical Affairs, Translational Medicine, Biostatistics and other study team members to meet project deliverables and timelines
Anticipate obstacles and difficulties of stakeholders and staff and acts upon them in order to meet team goals
Review and manage the eTMF for completeness and accuracy, ensuring inspection readiness, as applicable
Oversight of study documentation, ensuring timely completion and ongoing adherence to regulatory expectations, relating to data integrity and patient safety
Serve as a primary point of contact for internal and external study team members
Oversee the completeness, accuracy, and consistency of clinical data and data structure across the program on an ongoing basis
Perform management of CDM deliverables as described or provides oversight and guidance to Data Manager leading CDM deliverables
Lead CDM representative during internal audits as well as Health Authority audits
Lead the development, review, and implementation of processes, policies, SOPs, and associated documents affecting CDM and cross-functional groups
Lead and/or participate in CDM cross-functional initiatives
Proactively provide input into CDM organizational strategy and implements departmental change
Proactively provide input to continuous improvement activities within Clinical Data Management and leads the relevant support for implementation
Flexible to changing priorities, detail-oriented, works well under pressure, and able to take on unfamiliar tasks
Prioritize and effectively delegate study and initiative responsibilities
Assume expanded scope of responsibility with respect to volume and complexity of clinical project work as well as direct report responsibility
To be proficient in web-based Electronic Data Capture (such as Medidata Rave and other clinical data management systems)
Experienced with industry wide thesauri/dictionaries such as MedDRA and WHODD
Have excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
Experienced project management skills
Training and mentoring of all roles in CDM
Communication and escalation of project level issues including processes, timelines, resourcing, performance, etc.
Potential for direct report responsibility including oversight and development
Basic Qualifications:
High School degree and 12 years of experience
OR
Bachelor's Degree and Eight Years' Experience
OR
Masters' Degree and Six Years' Experience
OR
PhD / PharmD
Preferred Qualifications
Experience as independent lead in managing clinical data management deliverables for regulatory filings
Experience managing NIS studies in an oversight capacity
At least 10 years of relevant industry experience with clinical trials and a successful track record of leading through influence, working across complex, global organizational matrices
Experience in Industry Standards Guidelines (e.g., CDISC) in either the collection (CDASH), tabulation (SDTM), or analysis (ADaM) models
Strong knowledge of industry-leading EDC tools (e.g., Medidata Rave, Veeva EDC, Medrio EDC, Oracle, TrialGrid, etc.) and well versed in industry trends and emerging technologies supporting data collection
Experience interpreting Health Authority regulations and GCP/ICH guidelines with a strong compliance background
Strong working knowledge of the overall pharmaceutical development process
Influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a geographically diverse team
People Leader Accountabilities:
The salary range for this position is: $143,225.00 - $185,350.00. 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 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.
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.