Study Management Associate Jobs in Maryland (NOW HIRING)

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Join Kite, as we make even bigger advances in cancer therapies, and help shape where our business and medical science goes next.

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The Clinical Logistics Associate is responsible for end-to-end clinical cell therapy logistics execution, including patient enrollment readiness, apheresis coordination, manufacturing tracking, and final product delivery for pivotal trials. The role ensures chain of identity/custody integrity, manages orders and critical supplies, and works closely with clinical, manufacturing, global trade compliance, and 3rd party logistics (3PL) couriers. The associate tracks shipments and risks, serves as the primary point of contact for logistics product status, and proactively resolves issues to ensure the safe and timely delivery of Kite's lifesaving therapies.

This position requires 24/7 On Call Rotation

Responsibilities

End-to-end Cell Journey Execution

Works with the clinical logistics digital systems manager and change manager to ensure enrollment readiness

o Works with the CRO to acquire trial site information to pass to digital systems for configuration

Participates in trial Site Initiation Visit (SIV) training

Executes dry runs for trial sites that require it

o Travel as needed for in-person dry runs

Facilitates trial participant registration in the Salesforce cell journey orchestration platform

Ensures the trial participant meets clinical trial eligibility criteria prior to arranging apheresis collection

Ensures supply is at the trial site to facilitate apheresis collection

o Works with 3PLs to arrange transport of apheresis material to Kite manufacturing

o Uses the cell journey orchestration platform, 3PL systems, and communication with trial site to ensure product traceability and unbroken chain of identity (CoI) and chain of custody (CoC).

Tracks customs clearance and confirms delivery of apheresis product at manufacturing

Tracks manufacturing status and relays status and potential delays to the clinical trial site

Works with manufacturing Site Planning and QA Product disposition to arrange timely transport of QA released final IP back to the clinical trial site

Communicates expected delivery date to the clinical trial site and Study Management Team (SMT)

Tracks product pick-up, transit, and delivery of the final IP to the clinical trial site using the Salesforce cell journey orchestration platform, 3PL systems, and direct communication with the trial site and 3PL.

Cell Order Management

Uses the ERP to submit and book cell order for manufacture

Verifies cell order bookings to ensure accuracy and completeness in concert with other logistics staff

Supply Orders

Tracks and orders apheresis shipper kits for clinical trial sites to ensure clinical trial enrollment readiness

Ensures on-site (trial site) apheresis shipper kits are not expired using tools provided by clinical logistics management as well as by direct confirmation with trial site CRCs

Works with manufacturing Site Planning to order liquid nitrogen (LN2) dewars to enable shipment of final IP

o Ensures LN2 dewars are ordered early enough to ensure smooth operations and ensures dewars are returned immediately after use

Development Engagement

Participates in clinical trial Study Management Team meetings

o Ensures SMT established clinical trial milestones are met

o Provides updates to the SMT on IP delivery status and logistics readiness

Manufacturing Engagement

Works with various functions at manufacturing to ensure smooth operations

o Negotiates slot and confirms slot allocation with Site Planning

o Works with QA accessioning in the event of apheresis receipt issues

o Work with QA Product disposition to resolve events impeding timely final IP release and distribution

o Regularly communicates with Site Planning to discern final product status for communication back to the clinical trial site in the event of a manufacturing delay

Customs and Health Authority Compliance

Uses clinical logistics systems to generate customs invoices to ensure smooth cross-border transport of apheresis and final product IP

Works closely with GTC to provide visibility to all incoming and outbound cross-border shipments

o Notifies and works with GTC to resolve customs issues that arise in real-time an international border

Works with manufacturing QA and RA as needed to facilitate country specific health authority shipment requirements

Communicates with QP in countries that require in-country release to ensure timely delivery of final product

Operational Readiness and Coverage

Escalates execution risks and process gaps to management for awareness

Ensures logistics documentation is inspection ready and filed in accordance with applicable SOPs and eTMF requirements

Maintains complete and accurate CoI and CoC documentation for all shipments

Anticipates logistics risks and works with 3PLs and clinical logistics management to mitigate

Monitor active shipments, identify risks or deviations, and proactively triage and resolve logistics issues impacting patient treatment timelines.

Serve as the day-to-day logistics point of contact for clinical trial sites, CROs, manufacturing sites, and internal stakeholders.

Participate in the Clinical Logistics 24/7 on call rotation to support time critical logistics events outside standard business hours.

Basic Qualifications

• Bachelor's degree

OR

• Associate's degree with 2 years of experience

OR

• High school diploma with 4 years of experience.

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Supply Chain, Business, Information Technology or related field preferred

• Experience in clinical logistics, clinical operations, or clinical supply chain within the biopharmaceutical industry.

• Basic understanding of end-to-end clinical trial operations, including patient-specific logistics, global trial execution, and their impact on systems and operations.

• Any experience with cold-chain logistics or temperature-controlled biologics

• Any experience with ERP systems (EBS, SAP, etc.)

• Any experience with clinical trial tools and systems (CTMS, EDC, eTMF, IRT, IXRS, etc.)

• Any experience with DCS and QMS systems (Veeva, Agile, etc.)

• Basic knowledge of GCP, GMP, GxP, ICH, IATA principles and regulatory requirements.

• Excellent communication, and collaborative skills.

• Strong problem-solving abilities.

• Ability to manage complexity and multiple priorities in a fast-paced environment.

• Proficiency with Microsoft Office, SharePoint, Smartsheet, and other business systems

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 contactApplicantAccommodations@gilead.com for assistance.

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

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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.