Executive Director, Study Support & Oversight

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

Full Time Malvern, PA, US

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We exist to develop transformative new medicines for immune-mediated diseases, and we’re looking for bright-minded professionals driven by a desire to advance science and make a difference for people in need. Our lead asset, solrikitug, is a highly-potent TSLP inhibitor now in Phase 2 clinical trials for asthma, chronic obstructive pulmonary disease (COPD), and eosinophilic esophagitis (EoE) indications.

Join us in building an organization where people and science thrive together. You’ll have the opportunity to make a meaningful impact while working alongside a talented, agile team in an environment where ideas move quickly, colleagues are trusted, and quality remains a cornerstone.

Position Overview

The Executive Director/Director Study Support & Oversight is responsible for providing strategic and operational leadership across clinical trial support functions and study oversight activities within Uniquity Bio’s Clinical Operations organization. This individual will play a critical role in ensuring operational consistency, vendor performance, inspection readiness and high-quality execution across the clinical portfolio.

This role will be closely partnered with Clinical Operations leadership, Clinical Development, Biometrics, Clinical Quality, Regulatory Affairs and external vendors to support efficient study execution and operational excellence from study start-up through closeout.

The ideal candidate is highly organized, collaborative and operationally rigorous, with strong experience overseeing CROs, study support infrastructure and cross-functional clinical operations processes within a fast-moving biotech environment.

Key Responsibilities

Study Oversight & Operational Execution

• Manages team of Site Alliance Managers, Oversight Monitors and Clinical Trial Assistance in the execution of operational oversight and support across clinical studies to ensure consistent, high-quality trial execution
• Partner with study teams to monitor study progress, operational risks, timelines and key deliverables
• Support operational governance activities and escalation management across the clinical portfolio
• Ensure operational activities are conducted in alignment with protocol, SOPs, ICH-GCP and applicable regulatory requirements
• Help drive operational consistency and accountability across study teams and vendors
• Contribute to the identification of operational risks and develop mitigation strategies to maintain study quality and delivery timelines
• Contribute to the oversight and governance of CROs and external vendors supporting clinical studies
• Establish operational expectations, KPIs and performance management standards across external partners
• Review vendor metrics, deliverables and operational performance to ensure quality and execution expectations are met
• Attend vendor governance meetings, issue escalation discussions and operational review processes
• Support vendor selection, onboarding and partnership management activities

Clinical Operations Support Functions

• Lead SAM team to ensure accurate, real-time knowledge of site status
• Identify proactive barrier resolution
• Ensure appropriate documentation and engagement cadence
• Attend meetings prepared with data for clinical sites
• Oversee operational support activities including study tracking, reporting, inspection readiness support, documentation oversight and process management
• Partner with Clinical Quality and study teams to ensure operational documentation is inspection-ready
• Support Trial Master File quality and operational compliance activities
• Help establish scalable support models, tools and operational infrastructure to support organizational growth
• Contribute to portfolio-level operational planning and resource coordination

Cross-Functional Collaboration

• Partner closely with Clinical Development, Biometrics, Regulatory Affairs, Clinical Supply, Medical Writing and Clinical Quality to support integrated study execution
• Facilitate communication and alignment across internal stakeholders and external partners
• Support leadership visibility into study health, operational risks and delivery timelines
• Contribute operational expertise to study planning, governance and execution strategy discussions

Operational Excellence & Process Improvement

• Identify opportunities to improve operational efficiency, consistency and scalability across Clinical Operations
• Support development and refinement of SOPs, templates, trackers and operational processes
• Champion a culture of accountability, collaboration and continuous improvement
• Mentor team members and contribute to development of operational best practices across the organization

Qualifications

• Bachelor’s degree required; advanced scientific, healthcare or business degree preferred
• 12+ years of 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
• Experience supporting inspection readiness and operational quality initiatives preferred
• 5+ years of prior leadership and/or team management experience
• Strong operational leadership and organizational skills
• Skilled at managing multiple priorities across a dynamic clinical portfolio
• Excellent communication and stakeholder management capabilities
• Strong attention to detail and operational follow-through
• Ability to identify operational risks proactively and drive solutions, and to influence cross-functional teams and external partners effectively
• Collaborative, proactive and execution-oriented mindset
• Comfortable operating within a fast-paced, evolving biotech environment
• Strong judgment, prioritization and decision-making capabilities

At Uniquity Bio, we believe every team member has an impact on the patients we aim to serve. We are a nimble team with a rigorous approach to drug development that requires collaboration and transparency to maximize value, reduce risk, and deliver meaningful, best-in-class products. We are looking for self-starters who enjoy working in a complex, collaborative environment and are motivated to bring critical new medicines to people around the world. We are a small, fast-paced organization with a talented team of in-house employees and external consultants. Candidates must be self-motivated and able to work both independently and collaboratively to achieve success and impact in our dynamic work environment.

This is a U.S.-based position. Team members who live within commuting distance of our Malvern, PA or San Diego, CA office locations are expected to spend time in the office, and remote employees are expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed upon on a case-by-case basis with the employee’s manager. Business travel may be required depending upon the specific needs of the position.

The above job description is not intended to be all-inclusive. Requirements of the position may change from time to time based on business needs.

Uniquity Bio is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.