Kaléo

Role Description This is a remote opportunity with occasional travel, estimated at less than 25%. At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives. Our Patient Services team seeks a Senior Manager, Patient Access Operations, as we continue to enhance patient experience in acquiring AUVI-Q, our epinephrine auto-injector. This role is responsible for overseeing, optimizing, and managing the day-to-day operations of patient access channels to ensure timely initiation and continuity of therapy. The Senior Manager will lead and manage relationships with key vendor partners, such as hub and pharmacy partners, to maintain operational excellence. Leveraging data-driven insights, this individual will oversee the implementation of projects aimed at optimizing the patient experience. The ideal candidate is an accomplished operational leader with strong cross-functional collaboration abilities, outstanding communication, project management, and analytical skills. As Senior Manager, Patient Access Operations you will: - 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 Qualifications - Exceptional leadership, communication, and presentation skills. - Ability to influence and collaborate with senior executives and cross-functional teams. - Advanced analytical and problem-solving skills. - Expertise in vendor and project management. - Strong organizational skills and ability to manage multiple priorities. Requirements - Bachelor’s degree in Business Administration, Healthcare Administration, or related field is required. - Demonstrated experience in managing external partnerships. - Strong business acumen and proven track record in the pharmaceutical or healthcare industry. - Experience and expertise in managing complex, multi-stakeholder projects from planning through execution. Benefits - Advanced knowledge of hub and pharmacy operations. - Knowledge of direct-to-patient access solutions.

Role Description This is a remote opportunity with occasional travel, estimated at less than 35%. The Director, Platform & MCM Marketing is responsible for defining and leading the marketing strategy for Kaléo’s Aerio™ auto‑injector platform and Medical Countermeasures (MCM) portfolio, including currently marketed and products in development. This role serves as the strategic marketing lead for platform‑ and partnership‑driven growth, supporting government, defense, public health, and external development partners. As a senior member of the marketing and corporate communications leadership team, this role collaborates cross‑functionally to ensure Aerio and MCM capabilities are clearly, credibly, and consistently communicated to key stakeholders. Success in this role requires strong strategic thinking, executive‑level communication skills, and the ability to translate complex technical capabilities into compelling narratives that reinforce trust and reliability in high‑stakes environments. This position offers a unique opportunity to shape platform and partnership marketing strategy, lead high‑impact initiatives, and strengthen Kaléo’s leadership position in drug‑device combinations and auto‑injector innovation. The ideal candidate thrives in a fast‑paced, highly collaborative environment and can balance multiple strategic workstreams while maintaining high standards of quality and compliance. As Director, Aerio Platform & MCM Marketing, you will: - 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. Qualifications - Strategic Leadership: Ability to set direction, prioritize initiatives, and align platform and portfolio marketing with long‑term business goals. - Executive Communication: Exceptional verbal and written communication skills, with the ability to present complex concepts clearly to senior leaders, partners, and external stakeholders. - Analytical & Financial Acumen: Strong ability to interpret data, assess performance, and manage budgets to drive measurable impact. - Cross‑Functional Collaboration: Proven success working across technical, medical, regulatory, and commercial teams in highly regulated environments. - Problem‑Solving & Adaptability: Creative, resourceful, and comfortable navigating ambiguity in dynamic, evolving situations. - People Leadership: Experience developing talent, leading teams, and holding partners accountable to outcomes. - Commitment to Inclusivity: Active participation in and support of an inclusive workplace culture. Requirements - Bachelor’s degree or equivalent experience (advanced degree preferred). - 10+ years of marketing experience, including leadership roles in regulated industries such as pharma, biotech, medtech, defense, or government‑adjacent sectors. - Demonstrated experience with platform, partnership, or B2B marketing, including PR, thought leadership, and stakeholder engagement. - Preferred experience supporting the marketing or commercialization of products related to naloxone or other opioid overdose reversal therapies. - Vendor and agency management experience with accountability to KPIs and budgets. - Strong knowledge of the medical, legal, and regulatory landscape related to pharmaceutical or medical device marketing. - Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Role Description The Director, Quality Systems and Compliance, is accountable for the performance and sustained effectiveness of the Quality Management System (QMS) in support of patient safety, regulatory compliance, inspection readiness, and customer confidence across the product lifecycle. This role ensures quality systems are effective, reliable, and aligned with organizational objectives across development, manufacturing, and commercial activities. The Director serves as a senior quality leader and system owner, operating within established quality governance and direction. The role focuses on translating defined expectations into practical systems, processes, and controls, while providing strong external-facing leadership during regulatory, customer, and notified body audits. The Director, Quality Systems and Compliance, strengthens the Quality Assurance function by ensuring the QMS performs reliably under regulatory scrutiny, customer audit expectations, and ongoing operational demands. This role supports both internal product oversight and customer programs by maintaining quality systems that are auditable, inspection-ready, and aligned with regulatory and contractual requirements critical to patient safety and business continuity. As Director, Quality Systems and Compliance you will: - 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 through 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) Qualifications - Strong working knowledge of applicable FDA regulations and global quality standards, including 21 CFR Parts 210, 211, 11, and 820/QMSR, as well as ISO 13485, 14971, and related standards. - Ability to apply risk-based thinking and sound judgement within established direction and escalation pathways. - Demonstrated capability to manage multiple priorities while maintaining quality system effectiveness. - Clear, professional communication skills suitable for regulatory, auditor, and customer interactions. - Analytical mindset with the ability to identify trends, signals, and system-level issues. - Execution-focused leadership style with emphasis on follow-through, accountability, and results. Requirements - Bachelor’s degree in a life sciences discipline required; advanced degree preferred. - Progressive experience in Quality Assurance within pharmaceutical, medical device, and/or combination product environments, including responsibility for quality systems execution and external audits. - Demonstrated experience leading or supporting regulatory inspections and external audits. - Experience operating within customer-facing or multi-standard quality environments preferred. - Prior people leadership experience with accountability for performance and development. - Working knowledge of electronic QMS platforms and quality system reporting tools (for example: such as MasterControl, Veeva, TrackWise, Documentum, JReports, or equivalent systems/tools). - Ability to travel up to 25 - 40% overnight (depending on location).