Clinical Trials Manager

nant; City of Dunkirk (NY); Hybrid; USD 130,000 - 150,000; Full time

Benefits offered by this job

Discretionary bonus

Equity award

Job summary

ImmunityBio is seeking a Clinical Trials Manager to oversee multiple company-sponsored studies, manage site relationships, ensure protocol safety compliance, and assist with study documents. The role includes training site staff, coordinating updates, and supporting regulatory processes.

Candidates should have a biology degree with 5+ years in clinical research, and strong communication, organizational, and multitasking abilities in a fast-paced environment.

Qualifications

• Bachelor's degree in biological science with 5+ years of relevant experience in clinical research.
• Proficiency in MS Word, Excel, PowerPoint, Outlook.
• Excellent written and oral communication, strong organizational and multi-tasking skills.

Responsibilities

• Manage company-sponsored clinical trials and study documents.
• Guide clinical sites on protocol interpretation and safety compliance.
• Support site recruitment, initiation, payments, and close-out.
• Train clinical site staff and develop study tools.
• Prepare trial updates for the Clinical Development team.
• Lead or moderate DSMB and study teleconferences.

Skills

Communication skills

Organizational skills

Multi-tasking

Education

Bachelor's degree in biological science

Tools

MS Word

Excel

PowerPoint

Outlook

Job description

Company Overview

ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.

Why ImmunityBio?

• ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases.
• Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California.
• Work with a collaborative team with the ability to work across different areas of the company.
• Ability to join a growing company with professional development opportunities.

Position Summary

The Clinical Trails Manager is responsible for managing the activities of several clinical studies including assisting in the development of study-related documents, study site management, and patient data monitoring. The role will provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.

Essential Functions

• Assist in the development and management of company-sponsored clinical trials
• Assist in reviewing completed assignments by members of the clinical development group
• Assist in the development and management of revisions to study-related documents such as the informed consent, laboratory manual, pharmacy manual, case report forms (CRFs) and other study execution tools.
• Provide support in site recruitment, site initiation, site payments and site close-out.
• Help to oversee the training of new clinical site staff or site training for protocol amendments.
• Liaise with the regulatory department for the collection of updated regulatory documents as needed.
• Help to provide guidance to clinical sites on a daily basis including protocol interpretation and protocol safety compliance.
• Assist in the training of clinical development group staff.
• Prepare and update clinical trial updates for Clinical Development team
• Lead/moderate DSMB teleconferences, monthly PI and Study Coordinator teleconferences.
• Provide support for summarizing and maintaining patient treatment, response and survival data for active studies.
• Performs other duties as assigned.

Education & Experience

Bachelor's degree in biological science with 5+ years of relevant experience in clinical research required

Knowledge, Skills, & Abilities

• Proficiency in MS Word, Excel, PowerPoint, Outlook
• Excellent written/oral communication skills as well as strong organizational and multi-tasking skills.
• Understand the job-specific system and processes as defined by the company's SOPs and adhere to the requirements listed in those documents. If any of the procedure or process requirements are unclear or ambiguous, it is the responsibility of the employee to notify his/her supervisor or manager.
• Maintain corporate confidentiality at all times.

Working Environment / Physical Environment

This position works on site in or remotely depending on the geographic location of the candidate as noted in the offer letter.

Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.

This position will be exposed to an in-lab environment.

This position may travel approximately 20% of the time.

Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.

Lift and carry materials weighing up to 20 pounds.

This position is eligible for a discretionary bonus and equity award

This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.

National Market (all markets unless identified as Premium)

$130,000 (entry-level qualifications) to $143,000 (highly experienced) annually

Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston)

$136,500 (entry-level qualifications) to $150,000 (highly