Director of Project Management-Clinical

Role Description

The Director, Project Management–Clinical 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.

Key Responsibilities

• Clinical Project Leadership & Execution
  • 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.
• Risk Management, Insights & Issue Resolution
  • 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; escalate critical risks with clear recommendations.
• Study Feasibility, Enrollment & Site Strategy
  • 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.
• Budget & Process Management
  • 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.
• Governance, Compliance & Inspection Readiness
  • Ensure all clinical activities are conducted in accordance with GCP, regulatory requirements, and company policies.
  • Support inspection readiness and audit activities.
  • Ensure that collaboration with Medical Affairs, including MSL engagement, adheres to non-promotional and compliance standards.
• Reporting & Executive Communication
  • Provide regular updates on clinical study status, including timelines, risks, enrollment, and key milestones, to the CMO and executive leadership team.
  • Prepare materials for governance meetings and board-level updates as needed.
  • Ensure transparency and accuracy in all clinical project reporting.

Qualifications

• Bachelor’s degree in life sciences or related field required; advanced degree (MS, PhD, PharmD, or MBA) strongly preferred.
• 10–12+ years of experience in the biopharmaceutical industry, with at least 7–8 years in clinical project or program management within Clinical Operations.
• Demonstrated success leading global or multi-center clinical trials in a clinical-stage or pre-commercial environment.
• Deep understanding of clinical trial processes, including study start-up, enrollment, monitoring, data collection, and close-out.
• Experience working in or alongside Medical Affairs organizations, with exposure to MSL field models preferred.
• Proven expertise in project planning, risk management, budgeting, and vendor oversight.
• Strong leadership and influencing skills, with the ability to drive alignment across cross-functional teams without direct authority.
• Experience working closely with CROs and external vendors in a highly outsourced model.
• Proficiency with project management tools (e.g., MS Project, Smartsheet) and collaboration platforms (e.g., Teams, SharePoint).
• PMP certification or equivalent preferred.

Key Competencies

• Execution Excellence: Drives clinical studies forward with rigor and discipline.
• Strategic Translation: Converts clinical development strategy into actionable operational plans.
• Cross-Functional Leadership: Builds alignment across Clinical Operations, Medical Affairs, and external partners.
• Insight Integration: Effectively incorporates evolving field and site intelligence into trial execution.
• Risk Anticipation: Identifies and mitigates risks proactively.
• Agility: Adapts to organizational growth, including the phased build-out of new capabilities such as MSLs.
• Communication: Delivers clear, concise updates to senior leadership.

Salary Range

The posted salary range reflects the minimum to maximum base pay for this position in the specified location. Actual compensation may vary based on factors such as geographic location, experience, education, licensure requirements, and skill level, and will be determined at the time of offer. Base Salary Range: $215K – $230K

The Values We Hope You Share

• Purpose Driven: We are optimistic, focused and committed to delivering on our vision. We are hard-working, compliant, relentless and impatient in our pursuit of treatments.
• Transparent: We trust each other and expect honest and open communication to enable good decision making.
• Bold: We are courageous in our pursuit of excellence. Unafraid of risks and challenges.
• Intelligent: We are curious, passionate and self-aware. We seek diverse experience, knowledge, and skills to make informed, data-driven decisions.
• Unified: We collaborate as we strive for excellence, supporting each other and celebrating successes.