Manager, Clinical Programs

Role Summary

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.

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.

Qualifications

• Required: Bachelor’s degree in science required (Master’s or PhD preferred)
• Required: 4+ years of experience working as a Clinical Trial Manager or Clinical Program Manager
• Preferred: Experience with feasibility, project, budget, and resource management
• Preferred: Global experience managing Clinical Research Organizations (CROs), central labs and other vendors
• Required: Experience with project and resource management
• Required: Previous people management experience
• Required: Previous experience working in a dynamic and fast-paced environment
• Preferred: Experience in NDA submissions, experience with BLA submissions

Skills

• 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.

Education

• Bachelor’s degree in science required (Master’s or PhD preferred)

Additional Requirements

• This position will work on site in El Segundo, CA or remotely dependent upon geographic location of the candidate.
• Regular work schedule is Monday – Friday, within standard business hours. Flexibility is available with manager approval.
• Ability to work flexible hours for various time zones (management located in Southern California)
• Ability to travel as needed on a limited basis.