Senior Director, Clinical Operations

United States·Cambridge,Cambridgesenior

OperationsOtherHealthcareOperations DirectorClinical Operations

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Quick Summary

Key Responsibilities

Clinical operations leadership across assigned programs, including trial management, site monitoring, vendor selection and oversight, TMF, data operations,

Requirements Summary

Bachelor’s degree in a scientific discipline required; advanced degree preferred.

Technical Tools

OperationsOtherHealthcareOperations DirectorClinical Operations

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.

Responsibilities

~1 min read

→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.

Requirements

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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

What We Offer

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City Therapeutics is an Equal Opportunity and Affirmative Action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.