Senior Director, Clinical Operations/GI (301)
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/GI is responsible for providing operational leadership and execution oversight across Uniquity Bio’s gastrointestinal clinical development programs. This individual will play a critical role in the planning, implementation, management, and delivery of Phase 1–3 clinical trials, ensuring studies are executed with quality, speed, and operational excellence. This role will partner cross-functionally with Clinical Development, Biometrics, Regulatory, Medical Writing, Clinical Supply, Quality, and external vendors to advance programs from early development through pivotal-stage readiness. The ideal candidate is a highly collaborative and solutions-oriented leader who thrives in a fast-moving biotech environment and enjoys building scalable operational processes while remaining close to execution.
Requirements
- 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
- 5+ years direct people management experience required
- Demonstrated ability to manage complex studies with competing timelines and priorities
- Aptitude to work well with peers, with the executive team, and external audiences such KOLs and regulatory bodies
- Ability to thrive in a fast-paced, highly entrepreneurial environment, and to work effectively within a highly collaborative and matrixed environment
- Strong operational leadership and project management capabilities
- Excellent communication, organizational, and interpersonal skills
- Strong attention to detail with the ability to maintain strategic perspective
- Comfortable operating in ambiguity and helping build processes in a growing organization
- Capacity to influence cross-functional teams and external partners effectively
- Highly proactive, resourceful, and execution-oriented mindset
- Able to travel domestically and internationally (up to 20% of the time)
Nice To Haves
- GI/inflammatory disease clinical trial experience strongly preferred
Responsibilities
- Develop and implement global operational strategies to ensure timely, high-quality, and cost-efficient delivery of clinical studies
- Contribute operational insights to clinical development plans, feasibility assessments, and go/no-go decision-making
- 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
- Lead CRO and vendor selection, onboarding, governance, and performance management
- Lead oversight and governance of CROs and external vendors supporting clinical studies
- 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, and budget tracking
- Partner closely with Clinical Development, Biometrics, Data Management, Regulatory Affairs, Medical Writing, and Clinical Supply to ensure seamless trial execution
- Contribute operational expertise to protocol development, feasibility assessments, enrollment planning, and endpoint strategy
- Participate in cross-functional study team meetings and support program-level planning discussions
- 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
- Contribute to the evolution of Clinical Operations infrastructure, systems, and SOPs within a growing biotech environment
- 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
- Collaborate with the CMO, CSO, and CDO 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
- Represent the Clinical Operations function to the Uniquity Leadership Team
- 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
Benefits
- We celebrate diversity and are committed to creating an inclusive environment for all employees.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
