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The job details are as follows:The Director, Clinical Operations will lead the planning, execution, and management of all activities pertaining to clinical research trials and strategic clinical projects across multiple indications from operational planning through trial close out in compliance with UT processes and GCP/ICH and regulatory requirements. Builds and develops the people, the processes and the positive mindset making up the Clinical Operations team.
- Develop and execute, through effective delegation, strategies for the Medical Affairs department, including project-specific and cross-functional initiatives
- Establish the strategic foundation for projects and programs and empower the Clinical Operations team to drive continued development and execution
- Provide strategic oversight for Medical Affairs programs and projects, ensuring effective resource allocation, timeline management, and alignment with corporate objectives and budgets
- Regularly interact with senior management, executives, partners, and vendors to support Medical Affairs goals and objectives
- Build and maintain strong working relationships that promote collaboration and operational efficiency
- Escalate complex challenges to senior leadership, provide recommendations, and support resolution efforts
- Understand the interdependencies between Medical Affairs and other functions, and develop effective solutions to address complex cross-functional issues
- Foster and strengthen collaborative relationships within and across departments to support strategic clinical development objectives
- Champion the team's success by developing, enhancing, and supporting effective departmental and cross-functional SOPs and processes
- Lead and oversee budget planning, forecasting, and management activities for late-phase clinical trials
- Direct and manage the team, including goal setting, performance management, coaching, mentoring, change management, and career development
Minimum Requirements
- Bachelor's Degree in life sciences or relevant scientific discipline with 15+ years of experience in clinical trial management in a senior role including managing Phase 1-4 studies, CRO/vendor management, CRA management, and clinical site monitoring
- 7+ years of experience with managing clinical trial budgets
- 4+ years of people management experience
- Experience with all trial components supporting clinical studies
- Computer literate with experience in Microsoft software suite and other relevant packages
- Knowledge of Good Clinical Practice, regulatory processes, and clinical development processes
- Demonstrated & reproducible results in clinical operations
- Demonstrated ability to resolve issues with minimal supervision, and to understand when to escalate
- Embraces training, mentoring and professional development of staff
- Ability to work effectively under pressure
- Ability to influence without authority
- Ability to resolve issues with minimal supervision, escalating as needed
- Demonstrated negotiation and conflict resolution skills
- Advanced experience with successful collaboration across functions in a matrix environment
- Project Management experience
- Experience with Microsoft Office product suite required
- Ability to travel up to 20%
Preferred Qualifications
- Master's Degree in life sciences or relevant scientific discipline or
- Doctor of Philosophy (PhD) in life sciences or relevant scientific discipline
- 5+ years of experience in clinical trial management managing Phase 3b/4 studies
- 5+ years of technical and operational experience in planning/ executing/ reporting clinical trials
Eligible employees may participate in the Company's comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities
