Senior Director, Clinical Operations
$253.33k - $286.67kCity Therapeutics
SUMMARY: City Therapeutics is seeking a seasoned, Sr. Director-level subject matter expert to drive the advancement of our clinical programs while upholding our core values and mission. Reporting to the Head of Clinical Operations, the Senior Director will play a pivotal role in the strategic planning, oversight, and execution of one or more clinical programs. Please note this is a full-time onsite opportunity Key Responsibilities
- Program Oversight: Clinical operations leadership across assigned programs, including trial management, site monitoring, vendor selection and oversight, TMF, data operations, timeline and budget adherence
- Document Development: Collaborate with cross-functional teams to contribute to protocols, project plans, timelines, statistical analysis plans, and final study reports.
- Compliance & Quality: Ensure adherence to SOPs and GCP/ICH guidelines; maintain inspection readiness throughout the trial lifecycle.
- Risk Management: Proactively identify, resolve, and escalate issues that could impact timelines or budgets.
- Country and Site Strategy: Identify, evaluate, and recruit clinical trial locations and sites globally.
- Regulatory Support: Contribute to global clinical and regulatory submissions.
- Stakeholder Engagement: Serve as a subject matter expert, educating and engaging stakeholders to enhance organizational effectiveness.
- Team Leadership: Provide line management, coaching, and mentorship to assigned team members, as well as represent clin ops in various cross functional forums (Program team, sub-teams, etc).
- Process Improvement: Support the development and refinement of departmental SOPs and work instructions, streamline ways of working and create efficiencies throughout the lifecycle of clinical trials.
- Travel: May require domestic and international travel.
- Education: Bachelor's degree in a scientific discipline required; advanced degree preferred.
- Experience:
- Minimum 12 years in biotech/pharma/CRO settings
- At least 10 years in clinical operations
- Minimum 5 years in a supervisory role
- Track Record: Proven success in managing complex drug development trials.
- Leadership: Demonstrated ability to lead through vision, mentorship, and organizational development.
- Skills & Attributes:
- Highly organized, outcome-oriented, and self-motivated
- Adaptable to fast-paced environments
- Deep expertise in clinical operations and program management
- Strong interpersonal, conflict resolution, and negotiation skills
- Analytical thinker with strategic planning capabilities
- Excellent knowledge of federal regulatory requirements and GCP guidelines
- Exceptional oral and written communication skills
Vacancy posted 1 hour ago
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