Director of Clinical Study Oversight & Operations

Uniquity Design Group; San Diego (CA); Hybrid; USD 180,000 - 240,000; Full time

Job summary

Uniquity Bio in Malvern, PA is seeking an Executive Director/Director Study Support & Oversight to provide strategic and operational leadership across clinical trial support functions. This role partners with Clinical Operations, Biometrics, and Regulatory Affairs to drive consistent, high-quality trial execution from start-up through closeout.

The ideal candidate brings 12+ years of biotech clinical operations leadership, a deep understanding of ICH-GCP and FDA requirements, and a proven track

Qualifications

• Bachelor’s degree required; advanced scientific, healthcare or business degree preferred.
• 12+ years biotech/pharmaceutical clinical operations experience with increasing leadership responsibility.
• Strong experience overseeing CROs, vendors and operational delivery within clinical development programs.
• Experience supporting Phase 1–3 clinical trials within biotech, pharmaceutical or CRO environments.
• Strong understanding of ICH-GCP, FDA regulations and clinical trial operational requirements.
• 5+ years of prior leadership and/or team management experience.
• Excellent communication and stakeholder management capabilities.
• Ability to identify operational risks proactively and drive solutions across teams.

Responsibilities

• Lead study oversight and ensure high-quality trial execution across studies.
• Monitor study progress, operational risks, timelines and deliverables.
• Ensure governance, escalation management, and vendor oversight.
• Maintain inspection readiness and quality in Trial Master File.
• Collaborate across Clinical Development, Biometrics, Regulatory Affairs and external vendors.
• Develop SOPs, templates, trackers and scalable processes.

Skills

Leadership

Cross-functional collaboration

Operational excellence

Communication

Risk management

Education

Bachelor's degree

Advanced degree preferred

Job description

Uniquity Bio in Malvern, PA is seeking an Executive Director/Director Study Support & Oversight to provide strategic and operational leadership across clinical trial support functions. This role partners with Clinical Operations, Biometrics, and Regulatory Affairs to drive consistent, high-quality trial execution from start-up through closeout.

The ideal candidate brings 12+ years of biotech clinical operations leadership, a deep understanding of ICH-GCP and FDA requirements, and a proven track