Manager, Clinical Programs

ImmunityBio, Inc.El Segundo, CA
1dHybrid

About The Position

The Manager, Clinical Programs (MCP) will serve as the clinical operations leader in an assigned therapeutic program. This individual will be responsible for implementing the company’s goals and priorities as they relate to the assigned therapeutic program. The MCP must be effective in leading clinical research staff as well as being accountable to the highest levels of management. They will be an expert with regards to the clinical operations and status of the assigned therapeutic program. This is a highly visible role within the company.

Requirements

  • Bachelor’s degree in science required (Master’s or PhD preferred)
  • 4+ years of experience working as a Clinical Trial Manager or Clinical Program Manager required
  • Experience with feasibility, project, budget, and resource management preferred
  • Global experience managing Clinical Research Organizations (CROs), central labs and other vendors preferred
  • Experience with project and resource management required
  • Previous people management experience required
  • Previous experience working in a dynamic and fast-paced environment required
  • Experience in NDA submissions, experience with BLA submissions is preferred
  • Strong background in oncology clinical development
  • Demonstrated ability working directly with the highest levels of the company with ease
  • Excellent verbal and written communication skills in English
  • Knowledge of FDA guidelines as well as ICH/GCP Guidelines.
  • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.
  • Able to work comfortably with the highest levels of the company
  • Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously
  • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution
  • Ability to work collaboratively in a dynamic environment
  • Ability to mentor and develop junior employees within the assigned therapeutic program and more broadly across the clinical operations organization
  • Highly proficient in, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, eTMF, CTMS, and eCTD authoring templates
  • Maintain corporate confidentiality at all times.

Nice To Haves

  • Master’s or PhD preferred
  • Experience with feasibility, project, budget, and resource management preferred
  • Global experience managing Clinical Research Organizations (CROs), central labs and other vendors preferred
  • Experience in NDA submissions, experience with BLA submissions is preferred

Responsibilities

  • Lead a team of Clinical Trial Managers, Clinical Research Associates and Clinical Trial Associates to meet the goals and timelines of the assigned therapeutic program.
  • Act as the representative for program’s global clinical operations to functional group leaders, external vendors, and senior management.
  • Partner effectively and synergistically with stakeholders across the entire company
  • Manage Clinical Trial Managers on day-to-day activities and strategic initiatives.
  • Oversee the performance of designated team members, including interviewing, hiring and training employees, planning, assigning and directing work; coaching, mentoring, and conducting performance reviews.
  • Performs other special projects and duties as assigned.

Benefits

  • Medical, Dental and Vision Plan Options
  • Health and Financial Wellness Programs
  • Employer Assistance Program (EAP)
  • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
  • Healthcare and Dependent Care Flexible Spending Accounts
  • 401(k) Retirement Plan with Company Match
  • 529 Education Savings Program
  • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
  • Paid Time Off (PTO) includes: 11 Holidays
  • Exempt Employees are eligible for Unlimited PTO
  • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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