Executive Director / Vice President, Project Management

About Us

About the Role

The Executive Director or Vice President of Project Management will provide hands-on leadership to support integrated project planning across the full lifecycle of drug development, from early clinical development through regulatory approval and commercialization. 

You will be responsible for creating, maintaining, and driving detailed, cross-functional project plans that align clinical, regulatory, CMC, nonclinical, quality, and commercial activities to ensure the timely and successful delivery of clinical programs. You will serve as a central operational integrator, working closely with cross-functional teams to identify efficiencies, manage interdependencies, and ensure clear communication and execution at the program level.  This position includes mentorship and day-to-day guidance of junior project managers while remaining focused on detailed execution.

This is an exciting opportunity to join a growing clinical-stage organization as we continue to expand our pipeline. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.

Key Responsibilities

Project Planning

• Create, own, and maintain detailed integrated project plans and experience with multiple communication tools (e.g. Gantt charts, Dashboards, timeline views etc.) for one or more clinical programs across all stages of development.
• Define milestones, deliverables, dependencies and critical path activities in collaboration with functional teams.
• Ensure project plans are realistic, up to date, and reflect cross-functional assumptions and constraints

Cross-Functional Integration

• Partner closely with cross-functional teams, including Clinical Operations, Clinical Development, Regulatory Affairs, CMC, Nonclinical, Quality, Biostatistics, Medical Affairs, and Commercial.
• Facilitate project team meetings, working sessions and planning discussions to drive alignment and execution.
• Identify and manage cross-functional interdependencies, and handoffs and timing risks, ensuring visibility across teams.
• Proactively identify opportunities for operational efficiencies and improved coordination

Risk, Issue & Scenario Management

• Work with teams to identify project risks, gaps, and tradeoffs; document and track mitigation plans.
• Support scenario planning to assess schedule impacts and operational options.
• Clearly communicate risks, issues, and mitigation strategies to relevant stakeholders in a timely manner.
• Ensure transparency of issues, risks, and mitigation plans to senior leadership.

Operational Excellence & PM Capability Building

• Apply and continuously improve project management tools, templates, and best practices appropriate to the program stage and complexity.
• Ensure consistency, accountability, and execution rigor across programs.
• Mentor and support junior project managers, providing guidance on planning, dependency management, and cross-functional coordination
• Contribute to building scalable and practical project management capabilities within the organization.

Stakeholder & Executive Communication

• Act as a trusted partner to the executive team, providing clear, concise, and data-driven project insights.
• Prepare high-quality project updates and materials for program stakeholders and Senior Management
• Communicate project status, timelines, and risks effectively to support informed decision-making
• Serve as a reliable point of contact for day-to-day project timeline questions and coordination needs

Experience

• 15+ years of experience in biotech or pharmaceutical development, with hands-on involvement across clinical development through regulatory approval and commercialization.
• 10+ years of project management experience; PMP certification and Bachelor’s degree required.
• Demonstrated success building and managing detailed integrated project plans for complex clinical programs.
• Strong understanding of drug development processes, regulatory pathways, and cross-functional dependencies.
• Experience mentoring or guiding junior project managers (direct line management preferred)
• Experience with drug- device combination products is a plus
• Proven ability to operate at a detailed execution-focused level, balancing timelines, dependencies, and competing priorities.
• Strong organizational, communication, and collaboration skills