City Therapeutics · 2 weeks ago
Senior Director, Clinical Operations
Cambridge, MA
Full-time
Onsite
Director/Executive
$253K/yr - $287K/yr
12+ years expCity 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. The Senior Director will play a pivotal role in the strategic planning, oversight, and execution of one or more clinical programs.
BiopharmaLife ScienceTherapeutics
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
Qualification
Required
Bachelor's degree in a scientific discipline required
Minimum 12 years in biotech/pharma/CRO settings
At least 10 years in clinical operations
Minimum 5 years in a supervisory role
Proven success in managing complex drug development trials
Demonstrated ability to lead through vision, mentorship, and organizational development
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
Preferred
Advanced degree preferred
Benefits
Medical
Dental
Vision
Life insurance
Health and dependent care FSA accounts
HSA/HRA accounts with company contributions
401(k) with competitive company match
Company
City Therapeutics
City Therapeutics is a biopharmaceutical company focused on developing next-generation small interfering RNAs.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$135MKey Investors
ARCH Venture Partners
2024-10-08Series A· $135M
Leadership Team
Sebastian Trousil
Co-Founder and Chief Operating Officer
Recent News
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