Osteal Therapeutics

QA Engineer

• Lead supplier qualification, onboarding, and lifecycle management activities for critical suppliers supporting Osteal’s orthopedic combination product portfolio, ensuring supplier controls are appropriately scaled based on risk, product criticality, and regulatory impact.
• Drive supplier quality oversight across outsourced manufacturing operations, partnering closely with CMO/CDMOs and external manufacturing partners to ensure compliance with Osteal quality requirements, quality agreements, and applicable regulatory expectations.
• Conduct supplier audits, qualification assessments, surveillance audits, GMP audits, and for-cause investigations to evaluate supplier compliance with ISO 13485, FDA QMSR, 21 CFR Part 4, 21 CFR Parts 210/211, and internal quality system requirements.
• Serve as the primary quality liaison for supplier-related quality engineering matters, including nonconformances, investigations, deviation escalations, material review decisions, and supplier performance concerns.
• Lead supplier corrective action (SCAR) activities, partnering with suppliers to drive robust root cause investigations, effective containment actions, and sustainable corrective/preventive actions.
• Support cross-functional root cause investigations involving supplier-related product quality issues, complaint escalations, manufacturing deviations, and supply disruptions.
• Review and assess supplier-initiated changes; including material, process, equipment, site, sterilization, packaging, analytical, and subcontractor changes, to determine quality, validation, and regulatory impact.
• Ensure supplier quality agreements clearly define responsibilities related to change notification, deviation reporting, documentation requirements, complaint support, audit access, batch record expectations, and traceability obligations.
• Develop and maintain supplier performance monitoring programs using quality metrics and risk indicators, including defect trends, audit outcomes, SCAR responsiveness, change control compliance, complaint linkage, and delivery quality performance.
• Provide quality oversight of supplier validation and qualification activities where applicable, including sterilization validation, packaging validation, analytical method qualification, and manufacturing process controls.
• Partner with Supply Chain and operations, Regulatory Affairs, Product Development, Manufacturing, and Quality leadership to proactively identify and mitigate supplier quality risks.
• Support organizational inspection readiness by ensuring supplier oversight processes, documentation, and external quality controls align with FDA expectations and commercialization requirements.

Senior Supplier Quality Engineer

Manager

• Define the long-term educational roadmap for the Osteal field organization, from initial onboarding to advanced mastery.
• Conduct ongoing gap analyses to ensure training programs address the evolving needs of hospital environments and procedural workflows.
• Develop clear learning objectives and KPIs to measure the impact of training on field performance and case success rates.
• Lead the creation of comprehensive training modules focused on disease state knowledge, procedural steps, and technical troubleshooting.
• Develop specialized "Stakeholder Education" playbooks that teach the field team how to navigate and educate diverse hospital audiences (e.g., Surgeons, OR Managers, Sterile Processing, and C-Suite).
• Design high-fidelity case support simulations that prepare field members for the high-pressure environment of live surgical procedures.
• Ensure all educational materials are clinically rigorous, legally compliant, and aligned with brand positioning.
• Direct and facilitate live and virtual training intensives at events, including national sales meetings, regional workshops, and specialized clinical labs.
• Implement "Train-the-Trainer" certifications to ensure every field member can effectively translate Osteal’s value proposition to clinical staff.
• Provide real-time coaching and feedback to field personnel on their presentation skills, clinical acumen, and in-case etiquette.
• Equip the field team with the skills necessary to maximize positive customer and patient experience through proactive case preparation and intra-operative support.
• Develop standard operating procedures (SOPs) for field-led hospital staff training (e.g., in-services and training labs).
• Foster a culture of "Clinical Excellence" where the field team is viewed by the hospital as a value-added partner rather than just a vendor.

Senior Manager – Professional Education

Director

• The Head of Field Reimbursement is an exciting opportunity to make a meaningful impact for patients. This is a remote, field-based role. This role will report into the Senior Director of Market Access and HEOR. The FRM will support the launch of an upcoming drug, exclusively in the inpatient setting, for use during surgical procedures. They will work in collaboration with the sales and market access teams to provide full support to hospitals. Unlike buy-and-bill outpatient drugs, inpatient drugs are bundled into a DRG payment, often not separately reimbursed, and can be financially risky for hospitals.
• The FRM will play a critical role in communicating the financial story to hospitals with a budget impact model and understanding of the standard of care reimbursement dynamics. This role will educate on MS-DRG, NTAP, and outlier payments. They will also support proper coding of ICD-10-PCS procedure codes, accurate diagnosis capture, and proper documentation. Inservice support providing hospital education and managing objections will be imperative.
• This is a strategic leadership role and will be responsible to build out and hire a team of Field Reimbursement Managers over the next 6 months. Financial acumen and soft skills to ensure an open and ongoing relationship with hospitals is imperative. Operating within a fast-paced, pre-commercial environment, this individual will partner cross-functionally to align strategy and execution, while proactively navigating reimbursement, policy, and health system dynamics to optimize patient access and account performance.

Field Reimbursement Director

• Lead strategic account development and adoption to drive formulary access, organizational alignment, utilization growth, and long-term institutional partnerships for Osteal’s portfolio.
• Develop and execute enterprise-level account strategies aligned to corporate objectives, prioritizing high-value health systems, IDNs, and academic medical centers.
• Orchestrate account-specific access strategies, working cross-functionally to influence formulary inclusion, optimize reimbursement, and ensure integration into clinical protocols and EHR workflows across key institutions.
• Build and influence senior stakeholder relationships (pharmacy, P&T, antimicrobial stewardship, finance, and executive leadership) to shape institutional decision-making and accelerate access.
• Deliver high-impact pre-commercial engagements, including Pre-Approval Information Exchange (PIE), budget impact model (BIM), clinical dossier to educate stakeholders and proactively position the product ahead of launch.
• Translate clinical and economic evidence into compelling value narratives, tailored to diverse stakeholders (clinical, financial, and administrative) to support access and adoption decisions.
• Partner closely with Sales and Field Reimbursement teams to align strategy, coordinate execution, and ensure access success translates into effective pull-through and patient access.
• Track and drive performance against access and adoption objectives, continuously refining strategies based on account insights and market dynamics.
• Identify and prioritize high-impact opportunities to advance formulary positioning and ensure effective pull-through following access wins.

Director, National Accounts

Operations

• Collaborate with Commercial stakeholders to design, deliver and maintain technology solutions that align to Commercial’s business strategic direction.
• Design, develop, implement and lead the company's customer management system (CRM) with input from Commercial, IT, Quality and Finance.
• Support the build, implementation, and maintenance of sales tools, including CRM, data analytics, and sales dashboards.
• Lead the development of databases and infrastructure to support analytics, insights, forecasting and budgeting.
• Work with cross-functional team members to identify and prioritize actionable, high-impact insights across a variety of core business areas including Sales, Marketing, Finance and Market Access.
• Oversee market insights, analytics and competitive intelligence to deliver data driven business recommendations.
• Research, design, implement, and validate cutting-edge dashboards to analyze diverse sources of data to achieve targeted outcomes.
• Institute processes for data and reporting governance of ad-hoc field-based inquiries from the Executive Leadership Team and other Commercial functions.
• Lead data inquiry and data stewardship efforts in support of field-based teams.
• Strategic and tactical planning for field teams including management of vehicle allowance, incentive compensation design and administration, data management, reporting, and CRM management.
• Oversee field effectiveness and operations, including territory planning, sales performance tracking and analytics, incentive programming, and the development and delivery of customer engagement and sales enablement tools.
• Design, develop, implement and manage an integrated Case Management utility to ensure efficient coordination of NexChange procedure.
• Develop and oversee the operational budget, ensuring efficient allocation of resources and monitoring of key performance indicators (KPIs) to drive cost reduction and service improvement
• Work closely with Commercial and Finance to ensure accurate forecasting reporting.
• Develop a deep knowledge of the channel strategy along with standard of care fluency to support case logistics in the field by ensuring drug, device and representative readiness.
• Support the head of trade and distribution with data, reporting, and inventory management.
• Lead cross-functional launch readiness meetings, track risks, and manage cross-functional partners.
• Closely collaborate with leadership and support strategic cross-functional initiatives.
• Drive operational alignment, enablement, execution excellence and continuous improvement of commercial operations.

Director, Commercial Operations

Software Engineer

• Lead engineering execution associated with upgrading Osteal’s Fluid Management System and Wound Dressing Kit product platforms.
• Drive new product development initiatives from concept through commercialization.
• Assist sustaining engineering and product improvement activities for existing commercial-stage systems.
• Drive system-level design architecture, integration strategy, and engineering decision-making.
• Ensure strong execution of FDA-compliant design controls and engineering documentation.
• Support development and execution of verification & validation strategies.
• Collaborate closely with Software Engineering on system architecture, controls, alarms, integration, and reliability.
• Lead technical troubleshooting, root cause investigations, and field issue resolution.
• Support manufacturing supplier management and design transfer activities.
• Support technical documentation development for regulatory submissions and Agency communications.
• Collaborate closely with Regulatory Affairs and Quality on DDF development, risk management, V&V, and change control activities.
• Lead engineering activities associated with IEC 60601, IEC 62304, ISO 14971, and Human Factors Engineering.
• Lead and mentor engineering team members.
• Help establish a high-performance engineering culture centered around accountability, technical rigor, and execution speed.
• Coordinate internal engineering resources and external development partners.
• Support recruiting and development of future engineering talent.
• Collaborate cross-functionally across R&D, Quality, Manufacturing, Clinical, and Operations.

Director of Engineering

Vice President

• The Area Vice-President, Sales is a first-line sales leader responsible for launching the NEXCHANGE KIT, Osteal’s lead investigational therapy for periprosthetic joint infection, which has received FDA Breakthrough Therapy, Fast Track, Orphan Drug, and Qualified Infectious Disease designations. This role builds the regional Account Manager team, owns launch execution, surgeon adoption, and translates national strategy into account-level plans.
• The AVP partners across Marketing, Market Access, Medical Affairs and Training to deliver an aligned go-to-market strategy and serves as the voice of the field in shaping commercial strategy.
• The role demands an entrepreneurial builder with prior launch leadership, deep credibility in orthopedics and the operating room, and the resilience to drive results in a fast-moving, pre-commercial environment. As Osteal builds the commercial organization, this leader will have the opportunity to shape the future field structure, including recruiting and developing District Managers, and growing into broader second-line leadership responsibilities over time.

Area Vice President – West Coast

• Recruit, develop, and lead a high-performing team of Account Managers.
• Provide field-based coaching through joint calls and in-hospital support.
• Own regional sales forecasting, pipeline management, and performance reporting: conduct ongoing performance management and provide input on compensation plan design and quota setting.
• Translate national strategy into actionable regional, territory and account level plans aligned to launch objectives.
• Drive regional launch execution including site activation, surgeon adoption, and achievement of quarterly revenue and unit goals.
• Identify, develop, and cultivate regional KOLs and centers of excellence in orthopedic infection management.
• Partner cross-functionally with Marketing, Market Access, Medical Affairs, Training and Operations to drive aligned execution.
• Serve as the voice of the field, bringing insights that inform strategy and decision-making.
• Ensure team adherence to all applicable laws, regulations, and company policies.

Area Vice President – East Coast

Account Manager

• Own territory performance by driving demand and adoption, and deliver on assigned sales objectives.
• Develop and activate physician advocates who influence clinical adoption and broader hospital acceptance.
• Establish hospital access by navigating Pharmacy & Therapeutics (P&T) committees and related institutional review process in partnership with Market Access.
• Identify, prioritize, and advance growth opportunities across new and existing hospital accounts.
• Build strong, trust based relationships with orthopedic surgeons, infectious disease specialists, and key clinical stakeholders.
• Educate and train surgeons, perioperative teams, pharmacists, and other stakeholders to support appropriate use.
• Convert early adoption into repeat utilization and sustained territory performance
• Collaborate with internal partners and provide actionable field insights to inform strategy and execution.