Executive Director, Study Support & Oversight

Uniquity Bio Inc.•Malvern, PA

5d•Hybrid

About The Position

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 disorder (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. 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.

Requirements

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

Responsibilities

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
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