Director of Project Management-Clinical

The Director, Project Management – Clinical Development will lead the planning, execution, and oversight of clinical trial activities across LB Pharmaceuticals’ development programs, with a primary focus on ensuring operational excellence within Clinical Development. Reporting directly to the Chief Medical Officer, this individual will serve as the central driver of clinical study execution, ensuring alignment across internal teams and external partners (CROs, vendors, and clinical sites).

This role is accountable for end-to-end clinical trial delivery, including timelines, budgets, quality, and risk mitigation. As the organization evolves, this role will also support the progressive integration of a global Medical Science Liaison (MSL) function, ensuring that field-based insights are effectively incorporated into clinical planning and execution in a compliant and scalable manner.

This is a hands‑on leadership role in a fast‑paced, small‑company environment, requiring both strategic oversight and deep operational engagement.

• Lead the planning, execution, and tracking of clinical trials across Phase 1–3 studies, with a focus on LB-102 and future pipeline assets.
• Develop and maintain detailed clinical study timelines, including key milestones, critical paths, and interdependencies across Clinical Operations activities.
• Ensure alignment between clinical strategy and operational execution in partnership with the CMO and Clinical Development leadership.
• Serve as the primary liaison between Clinical Operations and cross‑functional stakeholders including Clinical Development, Regulatory, Data Management, Biostatistics, CMC, and Medical Affairs.
• Drive alignment of deliverables, timelines, and resources across internal teams and external vendors. Facilitate clinical study team meetings, ensuring clear communication, decision‑making, and accountability for action items.
• Partner with Clinical Operations leadership in the selection, onboarding, and oversight of CROs and vendors.
• Monitor vendor performance against scope, timelines, budget, and quality expectations.
• Ensure effective governance structures and communication pathways are in place with external partners.

• Proactively identify operational risks related to study timelines, enrollment, data quality, and vendor performance.
• Incorporate emerging field insights (e.g., site feedback, enrollment barriers, regional considerations) into risk identification and mitigation planning as MSL capabilities are established.
• Develop and implement contingency plans in collaboration with key stakeholders; elevate critical risks with clear recommendations.

• Lead study feasibility assessments, site identification, and enrollment planning in collaboration with Clinical Operations and Clinical Development.
• Over time, partner with Medical Affairs to incorporate MSL‑derived insights into site selection, feasibility, and enrollment optimization strategies.
• Monitor enrollment performance and adapt strategies based on both operational data and field‑based intelligence.

• Collaborate with Clinical Operations and Finance to develop, track, and manage clinical study budgets.
• Ensure alignment between study execution plans and financial forecasts.
• Support resource planning across studies, including internal staffing, CROs, vendors, and future field‑based medical support.
• Contribute to the development and implementation of scalable project management processes, tools, and governance frameworks.
• As the MSL organization is built, help establish clear, compliant processes for integrating field insights into clinical operations (e.g., structured feedback loops, feasibility inputs).
• Support development of SOPs and collaboration models between Clinical Operations and Medical Affairs to ensure appropriate boundaries and effective coordination.

• Ensure all clinical activities are conducted in accordance with GCP, regulatory requirements, and company policies.
• Support inspection readiness and…