Senior Manager, Clinical Operations

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.

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 Senior Manager will work closely 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 in a fast-paced biotech environment.

Key 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

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, 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

Cross-Functional Collaboration

• 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

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

Required Education and Experience:

• Bachelor’s degree required; advanced scientific or healthcare degree preferred
• 8+ years of biotech/pharmaceutical clinical operations experience, in the biotech, pharmaceutical, or CRO industry, 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

Required Knowledge, Skills, Abilities & Behaviors:

• Ability to work well with peers, with 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. 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.