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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Clinical Trial ManagementProject ManagementResource ManagementNDA SubmissionsBLA SubmissionsOncology Clinical DevelopmentDrug Development ProcessFeasibility StudiesBudget ManagementPerformance Reviews

Soft Skills

LeadershipCommunicationMentoringCritical ThinkingProblem SolvingCollaborationAttention to DetailTime ManagementCoachingInterpersonal Skills