Associate Director

Associate Director / Director Clinical Programs

Job Summary
The Associate Director / Director Clinical Programs leads the strategic coordination and prioritization of all clinical studies and programs. Ensures clinical activities are aligned with product development, regulatory strategy, and commercial launch timelines, while maintaining visibility and accountability across the full clinical evidence portfolio.
Acts as a central integrator between ClinDev/Ops, CMC, Pre-Clinical, Regulatory, Quality; drives governance, reporting and readiness across interdependent programs to enable informed decision making and optimized resource allocation.

Duties and Responsibilities

• Manages implementation of development plans by managing overall timelines and milestone status.
• Lead overall program level planning, prioritization, and tracking of all clinical studies supporting product development, lifecycle management and post market evidence generation.
• Manage the clinical roadmap in alignment with program milestones, regulatory submissions and commercial launch timelines.
• Leads CRO/vendor selection process for outsourced activities.
• Vendor management/governance.
• Builds, maintains and monitors performance metrics (internal and external stakeholders)
• Development/coordination of study training for Clinical Operations as needed.
• Ensure visibility of interdependencies across programs, including clinical, technical and operational linkages.
• Maintain a consolidated, forward looking portfolio view of study status, timelines and budget allocations.
• Collaborate with CMC to ensure product availability for planned clinical programs.
• Maintain portfolio dashboards, KPIs and risk registers for leadership visibility.
• Ensure on-time readiness of clinical evidence for regulatory and commercial milestones.
• Identify and manage cross department/program risks and dependencies across the clinical and product lifecycle.
• Proactively escalate bottlenecks or misalignments that could impact evidence generation or launch readiness.
• Supports all other clinical trial operations as needed/requested.

Qualifications

• BS in Life Sciences or related field
• 10+ years of experience in clinical program or portfolio management within MedTech, medical devices, cell therapy, diagnostics or life sciences.
• At least 4 years of experience of clinical operations experience.
• Strong knowledge of Good Clinical Practices and ICH guidelines and their application to the conduct of clinical trials.
• Strong understanding of clinical study design, regulatory pathways, and product development process.
• Proficient in portfolio planning tools (e.g. Smartsheet, Clarity, Planview, Power BI).
• Strong analytical, prioritization and resource management skills.
• Skilled communicator.
• Experience in epilepsy trials preferred but not required.

Must be willing to travel up to 20% domestically.

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