Kaleo Software

Operations

• Oversee Hub and Pharmacy Operations
• Serve as the day-to-day point of contact for hub and pharmacy operations
• Ensure adherence to contract terms and business rules
• Maintain vendor contracts, documentation, and reporting tools
• Review and audit all vendor invoices
• Oversee and track vendor performance against KPIs
• Attend and lead routine meetings with vendor personnel
• Identify compliant opportunities for process improvements
• Ensure accurate/timely delivery and completion of tasks and projects
• Communicate and present data/information regarding program performance, goals, and initiatives to internal and external stakeholders
• Define project scope, goals, deliverables, and success criteria for patient access initiatives
• Oversee implementation of access‑related projects that enhance the patient and provider experience
• Ensure Leadership & Cross-Functional Coordination
• Lead external teams by providing guidance, alignment, and support to meet shared targets and deliver key outcomes
• Coordinate workflows across internal and external stakeholders to ensure operational alignment
• Partner with internal teams (ie. Marketing, Distribution, Market Access, etc.) to ensure alignment and seamless execution
• Conduct Data Analysis & Insights
• Analyze and track program data to identify trends, barriers, and opportunities
• Translate insights into recommendations that guide strategic direction and operational improvements
• Maintain dashboards, reports, and performance summaries to support decision‑making

Senior Manager, Patient Access Operations

Marketing

• Define and lead the global marketing strategy for the Aerio platform and Medical Countermeasures portfolio, aligned with corporate objectives and partnership priorities.
• Develop platform‑level positioning and messaging that clearly articulates Aerio’s differentiated capabilities, performance, and human‑factors leadership.
• Lead the development of partnership‑ready marketing materials that support business development, government engagement, and external collaboration discussions.
• Provide strategic direction and oversight for MCM marketing initiatives supporting government, military, and public health stakeholders.
• Partner closely with Business Development, Medical, Engineering, Quality, Regulatory, and Manufacturing teams to ensure accuracy, compliance, and alignment across all external materials.
• Oversee agency and vendor relationships, including creative, PR, and media partners, with accountability to budgets, timelines, and performance metrics.
• Guide measurement and optimization of marketing effectiveness across key stakeholder audiences, using data and insights to inform strategy.
• Represent Aerio and MCM marketing in regulatory, medical, and legal review processes, ensuring materials meet internal and external standards.
• Contribute to corporate storytelling and thought leadership initiatives that reinforce Kaléo’s credibility, preparedness, and leadership in drug‑delivery technology.
• Develop and mentor team members, fostering a culture of ownership, collaboration, and continuous improvement.

Director, Platform & MCM Marketing

Compliance

• Audit & Inspection Leadership
• Lead regulatory inspections, notified body audits, customer audits, and third-party assessments, including preparation, on-site execution, response coordination, and remediation activities through closure.
• Serve as the quality representative for external audit engagements, including direct interaction with regulators, customers, notified bodies, and auditors.
• Quality Systems Execution & Improvement
• Execute and improve assigned quality systems to ensure sustained inspection readiness, regulatory compliance, and effective audit performance.
• Design, implement, and optimize quality system processes to sustain inspection readiness and regulatory compliance.
• Apply regulatory requirements, industry standards, and customer expectations to develop practical, risk-based quality system solutions.
• Identify quality system gaps, risks, and improvement opportunities through audit outcomes, trend analysis, and quality data review.
• Design and implement quality system improvements informed by regulatory intelligence, audit feedback, and operational experience.
• Quality Integration & Performance Monitoring
• Support quality integration for new product introductions, platform deployments, technology transfers, and customer onboarding activities.
• Partner with Development, Operations, Supply Chain, Regulatory Affairs, and Commercial teams to implement quality system requirements and improvements,
• Establish and report quality metrics, trends, and management inputs to leadership.
• Lead and develop quality systems staff though clear expectations, coaching, and performance management.
• Provide oversight of electronic GxP quality systems, ensuring compliance and effective coordination with system administrators responsible for day-to-day configuration support.
• Leadership & Management
• Lead, manage, and hold accountable assigned Quality Systems personnel, including setting performance expectations, providing ongoing feedback, and conducting performance evaluations in alignment with organizational policies.
• Identify capability gaps and support hiring, onboarding, and development activities to ensure the team can effectively execute quality system responsibilities.
• QMS Oversight
• The Director executes and oversees core elements of the QMS, with direct ownership of key activities, coordination of cross-functional inputs, and accountability for overall system performance, including but not limited to:
• Quality Risk & Change Management (Change Management, CAPA, Investigations)
• Product & Patient Impact Systems (Complaints, Field Alerts, Product Quality Investigations, APQR)
• Documentation & Data Integrity (Document & Record Control, GxP Computerized System oversight)
• Supplier & External Quality Oversight (Supplier Quality Management, Internal, Supplier, and Customer Audits)
• Inspection Readiness & Regulatory Compliance Intelligence (Regulatory and Notified Body Readiness, Inspection Intelligence)
• Quality Performance Monitoring (Quality Metrics, Trending, and Reporting)

Senior Manager, Patient Access Operations

Director, Platform & MCM Marketing

Director, Quality Systems – Compliance