Job Summary of the Sr. IT Project Manager, ERP & Process Improvement

We are seeking a highly skilled Sr. IT Project Manager with proven success delivering IT projects ranging from simple enhancements to complex, multi-system initiatives and implementations within the biomedical, life sciences, or healthcare technology sectors.  This hybrid role is based out of Tampa, FL, supporting the IT organization with a blend of project management, business process improvement, and organizational change management. This role will partner with cross-functional operational and corporate teams to improve systems, strengthen processes, deliver projects on time and on budget, and ensure successful adoption of technology solutions in a regulated environment.

Requirements of the Sr. IT Project Manager, ERP & Process Improvement

Required

• • Minimum 5 years of progressive project management experience in IT environments.
  • Minimum 3 end-to-end ERP Implementations.
  • Grasp of broader enterprise systems such as ERP, LIMS, HRIS, QMS, MES, CRM, data platforms, and/or validated systems.
  • Proven business process improvement achievements with quantifiable results.
  • Hands-on experience executing change management strategies and adoption plans.
  • Strong communication and executive presentation skills.

 Preferred

• • Certifications: PMP, Lean Six Sigma Green/Black Belt, and/or Agile.
  • Experience in biomedical, life sciences, pharma, biotech, med device, or healthcare.
  • Familiarity with regulatory frameworks and validated IT environments.
  • Previous work within an IT PMO or Digital Transformation group.

Responsibilities of the Sr. IT Project Manager, ERP & Process Improvement

The specific duties of the Sr. IT Project Manager, ERP & Process Improvement include but are not limited to:

Project Management

• • Lead full-lifecycle projects for IT systems supporting lab operations, research, clinical workflows, QA/RA, and enterprise functions.
  • Build and manage detailed project plans, schedules, budgets, and governance structures.
  • Ensure compliance with GxP, FDA guidance, HIPAA, cybersecurity standards, CSV, and organizational policies.
  • Manage vendors, contracts, and cross-functional resources supporting system implementations and enhancements.
  • Identify and mitigate risks, issues, and interdependencies with data-driven decision-making.

Business Process Improvement (BPI)

• • Analyze current-state processes across biomedical and IT domains; design measurable future-state improvements.
  • Facilitate process mapping, Lean/Six Sigma problem solving, and workflow optimization sessions.
  • Implement process controls and documentation aligned with regulatory and audit expectations.
  • Partner with QA/RA, lab, and business owners to ensure processes remain efficient and compliant.

Organizational Change Management (OCM)

• • Develop and execute OCM strategies for IT-led transformations, system deployments, and process redesigns.
  • Conduct stakeholder analysis, change impact assessments, and readiness evaluations.
  • Create communications, training, and adoption plans tailored to technical and scientific audiences.
  • Track adoption KPIs and adjust strategies to ensure sustained behavior and process change.

Stakeholder & Cross-Functional Collaboration

• • Serve as a strategic liaison across IT, research, lab operations, clinical, regulatory, supply chain, and leadership teams.
  • Facilitate workshops, requirements sessions, demos, and executive updates.
  • Drive alignment and ensure stakeholders understand impacts, timelines, and decisions.
  • Collaborate with cross-functional teams and vendors to deliver projects on time and within budget
  • Ensure system scalability, security, and adherence to best practices for enterprise architecture

Location

111 W. Oak Ave., Tampa, FL 

Benefits/Compensation

Job Summary of the Director, Market Development

The Director, Market Development reports directly to the Chief Marketing Officer and is a senior leader within the Commercial organization. The role owns and leads development of the market development strategy for their respective market that accelerates growth across priority segments and ensure fulfilment of Axogen’s mission and business purpose. This role leads the planning and execution of integrated marketing programs that strengthen Axogen’s brand perception, drive surgeon demand and adoption and influence customer behavior to change entrenched clinical behaviors and ensure progression toward standard‑of‑care status.

Requirements of the Director, Market Development

• Bachelor’s degree required; Advanced educational degree desirable.
• Minimum of 10 years of progressive experience in marketing and product management within the medical device, surgical implant, or biotech industry.
• Conceptual and applied understanding of strategy, and the strategic planning process.
• Demonstrated success in developing and scaling new market opportunities, preferably involving disruptive or paradigm‑shifting technologies.
• Strong technical and clinical acumen with the ability to shape evidence generation supporting adoption and reimbursement.
• Proven experience leading market change, measuring penetration, and driving uptake across adopter segments from early adopters to early majority.
• Experienced people leader with a strong record of talent development and employee engagement.
• Ability to make decisions with imperfect data and establish performance measures to enable course correction.
• Strong interpersonal, written, and verbal communication skills with the ability to influence across multiple stakeholder groups.
• Ability to manage multiple priorities in a fast‑paced environment, on time and within budget.
• Willingness to travel domestically up to 35%, with some international travel expected.

Responsibilities of the Director, Market Development

The specific duties of the Director, Market Development include but are not limited to:

Market Strategy & Direction

• Develop and execute market development strategies that change entrenched clinical behavior and overcome inertia in standards of care.
• Apply a strong strategic and analytical mindset to convert market data, trends, and insights into actionable growth strategies and measurable outcomes.
• Drive strategic market segmentation, targeting, and positioning to accelerate adoption and penetration of Axogen’s nerve repair algorithm and their inclusion in clinical guidelines and achievement of standard of care status.
• Ensure all strategies are translated into the Axogen sales and sales management process, and are monitored, managed and adapted based on objective criteria.
• Identify, size, and prioritize growth opportunities across new markets, new segments, and evolving customer needs.
• Translate evolving and unmet customer needs into portfolio requirements.

 Marketing Program Execution & Commercial Enablement

• Lead the planning and execution of integrated marketing programs that drive surgeon demand and adoption, influence customer behavior and strengthen Axogen brand perception.
• Define and enable compelling, market specific value propositions by partnering with sales leadership to build effective selling models, processes, and training that equip the field to confidently and consistently communicate clinical, economic, and quality‑of‑life value through practical, execution ready tools.
• Apply process‑driven launch excellence planning and program management disciplines to ensure scalable execution of new product and clinical indication launches with measurable impact.

 Insights & Analytics Leadership

• Develop deep understanding of customer journeys across clinical markets and identify interventions that drive behavior change.
• Leverage analytical capabilities to extract insights from market data, VOC, and performance metrics.
• Establish and monitor KPIs to evaluate effectiveness of market development initiatives and inform course correction.
• Share insights across marketing, sales, medical affairs, HEOR, and R&D to influence enterprise decision making

KOL, Society & Advocacy Ecosystem Leadership

• Establish and lead a comprehensive Key Opinion Leader (KOL) and professional society engagement strategy across priority markets, building and sustaining senior‑level relationships with influential clinical leaders, academic centers, and society leadership.
• Partner closely with Medical Affairs to advance advisory boards, peer‑to‑peer programs, congress engagement, and scientific collaboration, ensuring KOL insights directly inform marketing strategy, evidence generation, and long‑term portfolio planning.

 Leadership & Collaboration

• Lead, mentor, and develop high performing market development leaders and teams.
• Build organizational capabilities in strategic marketing, analytics, customer insight, and execution excellence.
• Foster a collaborative, cross functional leadership culture aligned with Axogen values and mission.

Location

111 West Oak Ave., Tampa, FL  33602

#LI-AC1

Benefits/Compensation

Job Summary of the Clinical Data Manager

The Clinical Data Manager performs hands-on clinical data management activities across Axogen’s clinical studies, with primary responsibility for supporting study start-up activities, overseeing data collection, performing data cleaning, and conducting ongoing data review to ensure adherence to study protocols. This role is accountable for maintaining accurate, complete, and inspection-ready clinical data from study start-up through database lock.

The Clinical Data Manager works closely within the core Data Management team and partners with Clinical Operations, Biostatistics, Medical, Clinical Systems, Quality, and external vendors to support eCRF design, edit check development, data review, reconciliation, and regulatory readiness. This is an individual contributor role reporting to the Director, Clinical Data Management & Systems.

Requirements of the Clinical Data Manager

• Bachelor’s degree in a health science, life science, mathematics, or related field required; master’s degree preferred
• 3–6+ years of hands-on clinical data management experience in a medical device, biotech, or pharmaceutical environment
• Experience performing data cleaning, query management, ongoing data review, and reconciliation activities
• Experience working in an Electronic Data Capture (EDC) system required; experience with Veeva EDC preferred
• Working knowledge of GCP, ICH guidelines, and 21 CFR Part 11 requirements
• Strong analytical and problem-solving skills with the ability to identify trends and resolve data quality issues
• Ability to manage multiple priorities across studies with consistent follow-through
• Demonstrated ability to work independently while collaborating with Clinical Data Management leadership and cross-functional partners to evaluate issues and align on data management decisions
• Familiarity with CDISC standards and industry best practices preferred
• Certified Clinical Data Manager (CCDM) certification or professional involvement with the Society for Clinical Data Management (SCDM) a plus
• Sponsor-side clinical data management experience preferred
• Experience supporting database lock and regulatory inspections preferred

Responsibilities of the Clinical Data Manager

The specific duties of the Clinical Data Manager include but are not limited to:

• Study Start-Up and Systems Interaction
  • Interpret study protocols to support eCRF design and development
  • Create and review edit checks to ensure data capture and validation align with protocol requirements
  • Review EDC builds and participate in UAT to confirm eCRFs and edit checks function as intended
  • Support production release readiness and assess the impact of study changes on data quality and review workflows
  • Assess protocol amendments to determine data, eCRF, and edit check impacts and support required database updates
  • Partner with Clinical Systems and vendors to review, test, and validate database changes resulting from protocol amendments or system releases

• Data Collection, Cleaning, and Review
  • Perform hands-on oversight of clinical data collection activities to ensure alignment with study protocol requirements
  • Perform data cleaning and ongoing data review from study start-up through database lock
  • Evaluate edit check performance during study conduct and support updates as needed
  • Generate, review, prioritize, and resolve queries in collaboration with investigative sites and vendors
  • Review data listings and other review outputs to identify discrepancies, trends, and data quality risks
  • Track data issues through resolution to support study timelines and database lock readiness
  • Perform and support reconciliation of clinical data with external data sources as applicable
  • Support post-implementation review of database changes to ensure data integrity and continued protocol adherence

• Collaboration and Execution Support
  • Work closely within the core Data Management team, as well as Clinical Operations, Clinical Systems, Biostatistics, Medical Monitoring, Quality, and external vendors to ensure accurate, complete, and inspection-ready clinical data throughout the study lifecycle
  • Support interim data reviews, data cuts, and database lock activities
  • Communicate data issues clearly and proactively to appropriate stakeholders

• Quality and Compliance
  • Perform data management activities in accordance with SOPs, GCP, ICH guidelines, and 21 CFR Part 11 requirements
  • Maintain inspection-ready documentation supporting data review, reconciliation, and data quality decisions
  • Support audits and inspections by clearly explaining data review activities, decisions, and outcomes

Location

111 West Oak Ave., Tampa, FL  33602

#LI-AC1

Benefits/Compensation

Job Summary of the Sr. Manager, Internal Audit

The Senior Manager, Internal Audit will establish and lead Axogen’s newly internalized Internal Audit function, overseeing all aspects of SOX compliance, internal controls, and operational audit activities. This individual will be responsible for designing, executing, and continuously improving the internal audit strategy while partnering cross‑functionally with Finance, IT, Operations, and other business units. The Senior Manager will serve as Axogen’s internal controls subject-matter expert, ensuring a strong control environment and alignment with regulatory expectations. The ideal candidate thrives in a fast-paced, collaborative environment and brings experience in a public company subject to SOX.

Requirements of the Sr. Manager, Internal Audit

• Bachelor’s degree in Accounting, Finance, or related field; CPA, CIA, or similar certification required (CIA preferred; CPA beneficial).
• Minimum 7 years of progressive internal audit, SOX, or public accounting experience, including experience in a public company environment or Big 4/public accounting.
• Minimum 5 years of leadership experience.
• Strong knowledge of SOX requirements, COSO internal control framework, and audit methodologies.
• Experience in MedTech, Pharma, Biotech, or other regulated industries preferred.
• Prior involvement in system implementations is a plus.
• Excellent analytical, organizational, and communication skills, with the ability to convey complex information clearly.
• Ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Strong problem-solving mindset with demonstrated ability to identify root causes and recommend scalable improvements.
• Advanced proficiency in Microsoft Office; strong Excel skills required.
• Experience with audit or GRC tools preferred.

Responsibilities of the Sr. Manager, Internal Audit

The specific duties of the Sr. Manager, Internal Audit include but are not limited to:

• Lead, mentor, and develop team members by fostering a culture of accountability, collaboration, and continuous growth; provide clear direction, set performance expectations, and support career development through coaching and feedback.
• Lead the development, execution, and ongoing enhancement of Axogen’s SOX program, including risk
• assessment, scoping, testing, documentation, and remediation tracking.
• Manage the transition of internal audit activities from a third‑party outsourced model to a fully in‑house function, establishing processes, frameworks, and best‑practice methodologies.
• Develop and maintain a formal risk assessment framework, ensuring consistent evaluation of likelihood, impact, and control effectiveness.
• Perform fraud risk assessments and identify areas requiring enhanced monitoring, testing, or preventive controls.
• Utilize analytics, data trends, and key risk indicators to augment risk assessment activities and improve audit planning.
• Partner closely with Finance, IT, and Operations in the design of processes, controls, process inefficiencies, and risks requiring mitigation or enhanced monitoring.
• Coordinate with external auditors regarding SOX reliance strategy, walkthroughs, testing schedules, and remediation plans.
• Perform end‑to‑end SOX control testing over the design and operational effectiveness of internal controls, including business process and automated controls impacting financial reporting.
• Oversee IT General Controls testing, including logical access, change management, segregation-of-duties compliance, and interface/job monitoring.
• Assess the design and operating effectiveness of key configuration and automated controls within key applications.
• Validate the completeness and accuracy of system-generated reports and data sets used in key financial and operational controls.
• Coordinate annual SOC 1 report reviews for third-party service providers, including evaluating complementary user entity controls and sub-service organizations.
• Track and validate remediation of control deficiencies and audit issues, partnering with business owners to implement sustainable solutions.
• Prepare clear, concise audit reports summarizing findings, root causes, and recommended corrective actions.
• Provide periodic reporting to senior leadership on audit results, trends, and opportunities for control enhancement.
• Prepare and deliver Internal Audit updates to the Audit Committee, including SOX status, key findings, remediation progress, risk assessment insights, and emerging risks.
• Evaluate third-party and outsourced service provider risks, including controls, data access, and continuity considerations.
• Collaborate with IT Security on cybersecurity-related risks that may impact financial reporting or operational audit scope.
• Support readiness efforts and future-state design relating to systems implementations, including ERP, HRIS and manufacturing systems, to ensure effective control design and documentation.
• Conduct operational, compliance, and process audits to assess risks, evaluate efficiency, and identify opportunities for improvement across the organization.
• Build strong, collaborative relationships across the business, promoting a culture of accountability and continuous improvement.
• Ensure compliance with company policies.
• Perform other related duties as assigned.

Location

111 West Oak Ave., Tampa, FL  33602

#LI-AC1

Benefits/Compensation

Clinical Site Liaison

About the Role

The Clinical Site Liaison (CSL) serves as a key field‑based extension of the Clinical Operations team, responsible for building strong relationships with investigative sites and ensuring high‑quality study execution. This role provides proactive support to sites, facilitates communication between site staff and internal teams, and helps remove operational barriers that impact enrollment, data quality, and patient experience. The ideal candidate thrives in a fast‑moving biotech environment and enjoys being the “face of the study” for clinical sites.

Key Responsibilities

Site Relationship Management

• Serve as the primary point of contact for assigned clinical trial sites, fostering strong, collaborative relationships.
• Conduct regular check‑ins (virtual or on‑site) to assess site needs, enrollment progress, and operational challenges.
• Ensure sites have timely access to study materials, training, and updates.

Enrollment & Study Support

• Monitor enrollment performance and partner with sites to identify recruitment opportunities and barriers.
• Support site‑level feasibility, start‑up activities, and readiness assessments.
• Provide guidance on protocol requirements, visit schedules, and operational expectations.

Quality & Compliance

• Reinforce adherence to protocol, GCP, and study‑specific procedures.
• Identify and escalate potential quality issues, data inconsistencies, or protocol deviations.
• Collaborate with CRAs, Clinical Operations, and Medical Monitoring to ensure timely issue resolution.

Cross‑Functional Collaboration

• Act as a conduit between sites and internal teams (Clinical Ops, Medical Affairs, Data Management, Safety).
• Share site insights to inform study planning, risk mitigation, and operational decision‑making.
• Support vendor coordination (central labs, imaging, ePRO, etc.) as needed.

Operational Excellence

• Participate in investigator meetings, site trainings, and study team calls.
• Contribute to development of site‑facing tools, communications, and best practices.
• Maintain accurate documentation of site interactions and follow‑up actions.

Qualifications

• Bachelor’s degree in life sciences or related field; advanced degree a plus.
• AD Level 8 years, Sr Manager 6 years of experience in clinical research (Clinical Study Manager, CRM or CSL or Clinical Trial Lead).
• Strong understanding of clinical trial operations, GCP, and site workflows.
• Excellent communication, relationship‑building, and problem‑solving skills.
• Ability to travel to investigative sites as needed.  Approximate travel 85%
• Experience in small biotech or fast‑paced clinical environments preferred.

What Success Looks Like

• Strong, trusted relationships with site staff.
• Improved enrollment performance and reduced operational friction.
• High‑quality data and fewer site‑level issues.
• Clear, timely communication between sites and internal teams.
• A positive, supportive site experience that reflects well on the sponsor.

 The salary range for the Senior Manager, Clinical Site Liaison is expected to be between $175,000 and $190,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.

The salary range for the Associate Director, Clinical Site Liaison is expected to be between $195,000 and $210,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.