Sr. CTM Associate - Oncology, Hematology or Cell Therapy

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

The Senior Clinical Trials Management Associate is a primarily an in-house sponsor position (although some travel is required) who will oversee multiple aspects of clinical trial conduct including study start-up, document generation and review, tracking of samples enrollment of study participants, and management of vendors.. The candidate must be knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH guidelines. The position will report to a Senior Clinical Trials Manager of Clinical Operations.

Responsibilities include but, are not limited to:

• Prepares and/or reviews study-related or essential study start-up documents as they relate to the supported clinical trials as delegated by the study manager (e.g., Clinical protocols, Informed Consent Forms, Investigator Brochures, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters).
• Works with multiple contract research organizations to communicate detailed timelines and ensure that transferred obligations and performance expectations are met. Provides corrective instruction, as necessary, when performance expectations are not being met.
• Attends internal team and other meetings as required.
• Provides training, as necessary, at investigator meetings and other trial-specific meetings such as site initiation visits and monthly teleconferences.
• Creates and reviews site feasibility assessments required for study participation.
• Manages and tracks key study deliverables such as screening, enrollment, biological samples and images, data flow and protocol deviations.
• Proactively identifies potential study issues/risks and recommends/implements solutions; ensures issues are escalated as appropriate to Senior Manager.
• Prepares metrics and updates to key deliverables for management.
• Assists in the resolution of clinical trial queries and data review for interim analysis, primary analysis and final database locks.
• Prepares site newsletters and other correspondence related to clinical trial conduct (e.g., best practices and lessons learned, frequently asked questions) in collaboration with the study team
• Assists in resolution of routine study questions from clinical trial sites in adherence to ICH GCP and the study protocol.
• May lead less complex studies and/or manage components of more complex studies as a member of the study team
• May participate in department initiatives or special projects, such as developing new tools or processes
• Ability to coach less experienced colleagues in solving problems
• Understands how decisions have an impact to the broader study goals
• Other duties as assigned.

Basic Qualifications

• BS/BA and 4+ years of related experience – OR -
• MS/MA d and 2+ years of related experience

Preferred Qualifications

• At least three years of clinical trial experience with oncology, hematology, cell therapy or related therapeutic area experience considered a plus
• Multiple years of experience managing the work of external candidates
• Must be willing to travel at least 25% (possibly more)
• Ability to manage time demands, incomplete information or unexpected events
• Must display strong analytical and problem solving skills
• Attention to detail required
• Outstanding organizational skills with the ability to multi-task and prioritize
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
• Working knowledge of transplant patient care and apheresis collection a plus

 

The salary range for this position is: $115,260.00 - $149,160.00. 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:

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.
 

For 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 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.

For Current Kite Pharma Employees and Contractors:

Please apply via the Internal Career Opportunities portal in Workday.