DirectJobHub
Jobs · Analyst

Senior Director, Clinical Operations/GI (301)

Uniquity Bio · United States · 1 mo ago
RemoteRemoteAnalystFull-time

Position Overview

The Senior Director, Clinical Operations/GI is responsible for providing operational leadership and execution oversight across Uniquity Bio’s gastrointestinal clinical development programs.

Key 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 milestone

  • 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

  • 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

  • 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

Similar jobs