Senior Director, Clinical Operations

City Therapeutics; Cambridge (MA); On-site; USD 253,000 - 287,000; Full time

Benefits offered by this job

Annual bonus

Equity compensation

Medical insurance

Dental insurance

Job summary

City Therapeutics is seeking a seasoned Senior Director of Clinical Operations to lead one or more clinical programs. The role reports to the Head of Clinical Operations and involves strategic planning, oversight, and execution of trials with global site management.

They require 12+ years in biotech/pharma/CRO settings, 10+ years in clinical operations, and 5+ years in supervision, with strong leadership and regulatory knowledge. On-site role with potential travel.

Qualifications

• Bachelor’s degree in a scientific discipline required or equivalent.
• Minimum 12 years in biotech/pharma/CRO settings.
• Minimum 10 years in clinical operations.
• Minimum 5 years in a supervisory role.

Responsibilities

• Provide clinical operations leadership across assigned programs, including trial oversight and site monitoring.
• Collaborate on protocols, project plans, timelines, SAPs, and final study reports.
• Ensure adherence to SOPs and GCP/ICH guidelines; maintain inspection readiness.
• Identify and mitigate risks impacting timelines or budgets.
• Identify, evaluate, and recruit trial locations and sites globally.
• Support global regulatory submissions and provide regulatory input.
• Engage stakeholders to enhance organizational effectiveness and knowledge sharing.
• Lead and mentor team members; represent clin ops in cross-functional forums.
• Support development and refinement of SOPs and workflows to improve trial lifecycle efficiencies.
• Travel as required (domestic and international).

Skills

Clinical operations

Program management

Leadership

Regulatory knowledge

Education

Bachelor’s degree in sciences

Job description

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 elevate 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.

Candidate Requirements

• 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

Compensation

The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including relevant skills, experience, internal equity, relevant education or training and market dynamics. In addition, this role is eligible for an annual cash bonus and equity compensation. City Therapeutics offers a comprehensive and competitive benefits package including medical, dental, vision, life insurance, health and dependent care FSA accounts, HSA/HRA accounts with company contributions, in addition to a 401(k) with competitive company match. Per Year Salary Range: $253,333 to $286,667 USD

City Therapeutics is accepting resumes/CVs from direct applicants only. Recruitment Agency inquiries or submissions will not be accepted at this time.

City Therapeutics is an Equal Opportunity and Affirative 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.