Job Description

Senior Clinical Trial Manager

San Diego Metropolitan Area

Salary: $160,000-$180,000

A clinical-stage cell therapy company based in San Diego is expanding its clinical operations team. Focused on developing treatments for autoimmune diseases and hematological cancers, the company uses a unique approach to cell therapy, harnessing Natural Killer (NK) cells that target B cells. These NK cells are engineered as an "off-the-shelf" therapy, which means they're produced in advance rather than derived from a patient's own cells, making treatment more accessible and scalable.

The team has been a pioneer in cell therapies, with one of the first IND filings for Lupus using cell therapy. Now advancing six indications-four in clinical stages-the company is working to streamline manufacturing and distribution to improve access to novel treatments. Their CEO brings over 20 years of experience in biotech and venture capital, including leadership roles in notable life sciences companies, while the CMO has an extensive background in clinical research from leading pharmaceutical firms. This role offers the opportunity to contribute to the ongoing development of therapies at the intersection of cell therapy and auto-immunology.

Primary Responsibilities

• Support the Clinical Project Manager in planning and overseeing company-sponsored global clinical trials.
• Take the lead in reviewing work completed by members of the clinical development team.
• Lead or assist in revising study-related documents, such as informed consent forms, laboratory manuals, pharmacy manuals, case report forms (CRFs), and other tools essential for study execution.
• Provide assistance with site recruitment, initiation, payments, and close-out activities.
• Contribute to the training of new clinical site staff and offer additional training for protocol amendments.
• Coordinate with in-house teams to ensure timely collection of regulatory documents as required.
• Offer daily guidance to clinical sites, including interpretation of protocols and adherence to protocol safety standards.
• Lead or assist in training staff within the clinical development group.
• Work with the CPM to prepare and update trial progress reports for the Clinical Development team.
• Support the tracking and summarization of patient treatment, response, and survival data for ongoing studies.
• Perform other tasks as assigned.

Qualifications

• Bachelor's degree with 7-10 years of experience in clinical research.

Skills & Competencies

• Proficiency in MS Word, Excel, PowerPoint, and Outlook.
• Strong written and verbal communication skills, with excellent organizational and multitasking abilities.
• Understand and follow job-specific systems and processes as outlined in the company's SOPs, and seek clarification from a supervisor if any requirements are unclear.
• Consistently maintain corporate confidentiality.

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