Manager, Clinical Programs
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Job Description
Manager of Clinical Programs leading clinical operations at ImmunityBio, a biotechnology company developing cancer therapies. Responsible for team management and strategic initiatives within clinical research.
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.
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.
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
- We are committed to providing you with the tools and resources you need to optimize your Health and Wellness.
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