Senior Manager, Clinical Operations

About the role

Uniquity Bio is a clinical-stage biotechnology company committed to putting science and patients first. We develop transformative new medicines for immune-mediated diseases. 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. The Senior Manager, Clinical Operations provides operational leadership and execution oversight for assigned gastrointestinal clinical studies within Uniquity Bio’s clinical development portfolio.

This individual will be responsible for the planning, implementation, management, and delivery of clinical trials, with a focus on ensuring studies are executed with quality, efficiency, and operational excellence. The role involves close collaboration with Clinical Development, Biometrics, Regulatory Affairs, Clinical Quality, Medical Writing, Clinical Supply, and external vendors to support successful study execution from start-up through database lock and closeout.

The ideal candidate is a highly organized, collaborative, and solutions-oriented clinical operations leader who thrives in a fast-moving biotech environment and can effectively manage complex studies, proactively identify risks, and drive accountability across internal teams and external partners.

Responsibilities

• Clinical Trial Leadership & Execution
  • Provide operational leadership for assigned GI clinical studies and other studies as assigned.
  • Monitor enrollment, site performance, study timelines, and operational metrics.
  • Support feasibility assessments, enrollment planning, and study execution strategies.
  • Provide operational input into protocol development and study planning.
  • Develop and implement global operational strategies to ensure timely, high-quality, and cost-efficient delivery of clinical studies.
  • Lead day-to-day operational oversight of global and/or US-based GI clinical studies across multiple phases of development.
  • Develop and manage study timelines, operational plans, study budgets, and trial milestones.
  • Ensure studies are conducted in accordance with protocol, ICH-GCP, SOPs, and applicable global regulatory requirements.
  • Identify operational risks proactively and develop mitigation strategies to maintain study quality and delivery timelines.
  • Drive study start-up, enrollment, database lock, and closeout activities.
• CRO & Vendor Oversight
  • Provide day-to-day oversight of CROs and external vendors supporting assigned studies.
  • Participate in CRO governance and operational review meetings.
  • Review CRO and vendor performance and deliverables to ensure quality and timely execution.
  • Identify, escalate, and support resolution of vendor performance issues.
  • Lead CRO and vendor selection, onboarding, governance, and performance management.
  • Establish clear expectations, KPIs, and accountability measures across external partners.
  • Review vendor deliverables to ensure quality, consistency, and alignment with study objectives.
  • Escalate delivery and quality issues appropriately and drive resolution through risk mitigation plans.
  • Collaborate with Finance and leadership on forecasting, scope management, budget tracking, and forecasting.
• Cross-Functional Collaboration
  • Partner closely with Clinical Development, Biometrics, Data Management, Regulatory Affairs, Medical Writing, and Clinical Supply to ensure seamless trial execution.
  • Lead cross-functional study team meetings.
  • Ensure timely communication and alignment on study priorities, risks, decisions, and deliverables.
  • Contribute operational expertise to protocol development, feasibility assessments, enrollment planning, and endpoint strategy.
  • Support program-level planning discussions.
  • Work closely with Preclinical Development, Regulatory Affairs, Clinical Pharmacology, Biometrics, and Clinical Quality to ensure alignment and integration of development strategies.
  • Manage external partnerships including CROs and specialized consultants.
• Inspection Readiness & Quality
  • Maintain a proactive, risk-based approach to study execution and oversight.
  • Support audits, inspections, CAPAs, and other quality activities as needed.
  • Support inspection readiness activities and maintain a strong quality mindset throughout study execution.
  • Ensure operational documentation is inspection-ready and maintained according to internal standards.
  • Partner with Clinical Quality and Pharmacovigilance teams to support issue escalation and resolution as needed.
• Operational Strategy & Process Improvement
  • Identify opportunities to improve study execution, efficiency, and quality.
  • Contribute to the development and implementation of Clinical Operations SOPs, processes, templates, and tools.
  • Share lessons learned and contribute to continuous improvement initiatives.
  • Help establish scalable processes, templates, and best practices to support future pipeline growth.
  • Mentor junior team members and contribute to a collaborative, accountable, and solutions-focused culture.
• Strategic Leadership
  • Collaborate with the CMO and CSO to define and execute clinical strategies across the development lifecycle.
  • Set annual goals, KPIs, and performance standards that align with organizational objectives.
  • Foster a culture of collaboration, problem-solving, and continuous improvement across the operations function.
  • Effectively coordinate internal team members and external partners to achieve study objectives.
• Communication & Executive Representation
  • Provide regular updates to Clinical Operations leadership on study status, milestones, enrollment, risks, quality, and key deliverables.
  • Present key program updates, clinical milestones, KPIs, risks, and mitigations clearly and credibly.
  • Serve as a high-impact communicator both internally and externally through written reports and verbal presentations.
  • Escalate significant operational risks and issues with clear recommendations and proposed mitigation strategies.
  • Prepare and present study updates and operational metrics to cross-functional and governance teams.
  • Represent Clinical Operations effectively with internal and external stakeholders.

Requirements

• Education & Experience
  • Bachelor’s degree required; advanced scientific or healthcare degree preferred.
  • 8+ years of biotech/pharmaceutical clinical operations experience, including oversight of global Phase 1–3 trials.
  • GI/inflammatory disease clinical trial experience strongly preferred.
  • Experience managing CROs and external vendors within lean biotech environments.
  • Strong understanding of ICH-GCP, FDA regulations, and clinical trial execution standards.
  • Demonstrated ability to manage complex studies with competing timelines and priorities.
• Skills & Abilities
  • Ability to work well with peers, the executive team, and external audiences such as KOLs and regulatory bodies.
  • Excellent presentation and communication skills.
  • Ability to thrive in a fast-paced, highly entrepreneurial environment.
  • Excellent interpersonal skills.
  • 5+ years direct people management experience required.
  • Ability to travel domestically and internationally (up to 20% of the time).

Work Environment

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.

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.