Senior Director, Clinical Operations/GI (301)

Senior Director, Clinical Operations/GI (301) Full Time Malvern, PA, US 6 days ago Requisition ID: 1005 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. Key Responsibilities: Clinical Trial Leadership & Execution 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. Cross-Functional Collaboration 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. Inspection Readiness & Quality 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 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. Strategic Leadership 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. Communication & Executive Representation 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. Other Duties: Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. 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 KOLs and regulatory bodies. Excellent presentation and communication skills. Ability to thrive in a fast-paced, highly entrepreneurial environment. Excellent interpersonal skills. Ability to travel domestically and internationally (up to 20% of the time). Strong operational leadership and project management capabilities. Ability to work effectively within a highly collaborative and matrixed environment. 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. Ability to influence cross-functional teams and external partners effectively. Highly proactive, resourceful, and execution-oriented mindset. The position is US based. Team members who live within commuting distance to either our Malvern, PA or San Diego, CA office locations are expected to spend the majority of their work time physically present in the office interacting with other team members. Remote employees will be expected to travel to an office on a regular basis. Specific details for both local and remote staff will be discussed and agreed 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. #J-18808-Ljbffr Uniquity Design Group