Senior Director, Clinical Ops Excellence/Performance & Delivery

Uniquity Bio Inc.•Malvern, PA

6d•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 Senior Director, Clinical Operations Excellence / Performance & Delivery is a strategic operational leader responsible for driving consistency, scalability, quality and execution excellence across Uniquity Bio’s Clinical Operations organization. This individual will lead the development and optimization of operational processes, performance metrics, study governance frameworks, vendor oversight standards and delivery models that support the successful execution of Uniquity’s clinical portfolio. They will serve as a key operational partner to Clinical Operations leadership and cross-functional stakeholders, helping ensure studies are executed efficiently, proactively and with a strong culture of accountability. The ideal candidate is highly collaborative, operationally rigorous and energized by building infrastructure within a fast-moving biotech environment. This role is ideal for a leader who enjoys creating order from complexity while maintaining a practical, hands-on approach.

Requirements

Bachelor’s degree required; advanced scientific, healthcare or business degree preferred
12+ years of biotech/pharmaceutical clinical operations experience, including leadership responsibility across
Significant experience building or leading Clinical Operations Excellence, delivery management, operational strategy or portfolio oversight functions
Deep understanding of Phase 1–3 clinical trial execution and operational delivery models
Experience developing operational metrics, governance frameworks and performance reporting systems
Strong experience managing CROs and external vendors within lean biotech or fast-growth environments
Demonstrated success driving operational improvements and organizational scalability
Strong strategic and operational leadership capabilities
Exceptional project management and organizational skills
Ability to influence across functions and levels of the organization
Strong executive presence and communication skills
Ability to operate effectively within ambiguity and rapidly evolving priorities
Highly collaborative, solutions-oriented and proactive mindset
Strong analytical and problem-solving capabilities
Ability to balance strategic thinking with hands-on execution
Passion for building high-performing operational teams and infrastructure

Responsibilities

Lead the development, implementation and continuous improvement of Clinical Operations processes, standards, tools and governance frameworks
Establish scalable operational infrastructure to support growth across a multi-program clinical portfolio
Drive consistency across study execution models, documentation standards and operational workflows
Develop and maintain Clinical Operations, templates, trackers and best practices
Provide input to Clinical Operations SOPs
Identify operational gaps, inefficiencies and process improvement opportunities across the organization
Develop and deliver high-quality presentations and executive-level materials for Board meetings, senior leadership, and internal and external stakeholders, translating complex clinical and operational information into clear, strategic, and audience-appropriate communications
Develop and oversee Clinical Operations KPIs, metrics dashboards and delivery reporting frameworks
Partner with study teams and leadership to monitor study performance, timelines, risks and operational health
Drive operational accountability through clear performance tracking and proactive issue escalation
Support portfolio-level planning, resource forecasting and operational prioritization
Establish governance models and operational review processes that improve execution visibility and decision-making
Develop vendor oversight frameworks and performance management standards across CROs and external partners
Partner with study teams to ensure vendor deliverables, timelines and quality expectations are consistently met
Lead operational business reviews and performance discussions with key vendors
Support vendor selection, onboarding and governance strategies across the clinical portfolio
Help optimize external partnerships to improve operational quality, efficiency and scalability
Partner closely with Clinical Development, Biometrics, Regulatory Affairs, Clinical Quality, Clinical Supply and Finance to support integrated study delivery
Serve as an operational advisor to Clinical Operations leadership on delivery risks, resource planning and execution strategy
Facilitate cross-functional alignment around timelines, priorities and operational expectations
Support inspection readiness and quality-focused operational practices across programs
Mentor and develop Clinical Operations team members and operational leaders
Foster a culture of accountability, collaboration, urgency and operational excellence
Help shape organizational structure, roles and scalable operational support models as the company grows
Contribute to strategic planning initiatives within Clinical Operations and broader Development organization