Executive Director, Study Support & Oversight

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

Lead SAM team to ensure accurate, real-time knowledge of site status

Identify proactive barrier resolution

Show measurable enrollment impact (Site enrollment vs target, screening-enrollment conversation)

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

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

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

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.