AxoGen (AXGN) is a global leader in innovative surgical solutions for peripheral nerve injuries. AxoGen is focused on the science, development and commercialization of technologies for peripheral nerve regeneration and repair. Peripheral nerves provide the pathways for both motor and sensory signals throughout the body. Every day, people suffer traumatic injuries or undergo surgical procedures that impact the function of their peripheral nerves. Damage to a peripheral nerve can result in the loss of muscle or organ function, the loss of sensory feeling or the initiation of pain. Injuries to peripheral nerves can significantly impact the patient’s quality of life.
AxoGen's portfolio of products includes Avance® Nerve Graft, an off-the-shelf processed human nerve allograft for bridging severed nerves without the comorbidities associated with a second surgical site, AxoGuard® Nerve Connector, a porcine submucosa extracellular matrix ("ECM") coaptation aid for tensionless repair of severed nerves, AxoGuard® Nerve Protector, a porcine submucosa ECM product used to wrap and protect injured peripheral nerves and reinforce the nerve reconstruction while preventing soft tissue attachments and Avive™ Soft Tissue Membrane, a minimally processed human umbilical cord membrane that may be used as a soft tissue covering to reduce inflammation and scar tissue formation. Along with these core surgical products, AxoGen also offers AxoTouch™ Two-Point Discriminator and AcroValTM Neurosensory & Motor Testing System. These evaluation and measurement tools assist healthcare professionals in detecting changes in sensation, assessing return of sensory, grip and pinch function, evaluating effective treatment interventions, and providing feedback to patients on nerve function. The AxoGen portfolio of products is available in the United States, Canada, the United Kingdom and several European and international countries.
AxoGen maintains its corporate offices in Alachua, Florida.
AxoGen provides a great work environment that includes a fast-paced innovative team with a strong commitment to restoring quality of life to patients with nerve injuries.
The Project/Program Manager is responsible for the overall coordination and management (organization, planning, execution, control and evaluation) of AxoGen’s Biologic License Application (BLA) program for AxoGen products. The role will provide management and oversight to ensure organizational readiness to deliver an impactful and timely BLA submission. The role will be accountable for managing and building a Project Team (cross functional across AxoGen departments) to lead to a successful BLA submission. Project/Program Manager will update Leadership and Executive Team on aspects of the BLA program including:
- Clinical Programs (Pivotal and Supporting Studies)
- Regulatory (Regulatory Strategy, Panel Prep, Regulatory Submissions)
- Marketing (Labeling, Claims, M/S roll out planning, Reimbursement, Trademarks)
- Development (Pre-Clinical, Assays, Stability Studies, CMC, Optimizations, IP)
- Operations (GMP implementation, Facilities Group Review Prep and Readiness, Storage and Distribution, Labeling Update)
- Finance (Preparation and Planning for transition)
- Legal (Contracts)
Educational Requirements / Qualifications
- BSc in relevant scientific discipline, advanced degree and/or a degree/certificate in project management a plus.
- Five-to-eight years of experience leading the project management function in a scientific organization.
- Experience with Microsoft Office, Microsoft Project and Microsoft 365.
- Knowledge of biologics/drugs and manufacturing, and experience in a clinical setting strongly recommended.
- Understanding of the drug/biologics development, regulatory requirements up to an including commercialization strongly recommended.
Primary Responsibilities: The specific duties of the BLA Project/Program Manager include but are not limited to:
- Work with the Project Team and sub-teams to develop project plans that delineate team objectives, activities, timelines, and resources required to ensure consistency across the Program.
- Establish Project Management procedures, tracking and reporting processes, key performance indicators, risk assessments/monitoring and establish reporting metrics dashboard to executive review to ensure milestones and goals are met (deviations) and if not, plan and develop alternative scenarios, with the Project Team, to address deviation and gain approval on path forward.
- Coordinate with other Project Team leaders/members within both internally and externally facilitate timely and accurate reporting of progress across the portfolio of activities.
- Establish clear communication channels between internal and external sites and other key stakeholders to ensure that accurate and current delivery schedules are clearly communicated and understood by all parties.
- Engage with all relevant stakeholders to implement appropriate project tracking ensuring alignment across sub-teams with up-to-date reporting.
- Work with project teams to ensure programs are delivered on time, on scope and on budget.
- Create annual budget with Department Heads.
- Collaborate with project team members to author project team meeting agendas and capture meeting minutes.
- Accountable for the deliverables of the project including budget and timeline.
- Report progress of project to the executive team of the company.
We are seeking candidates who are AxoGenic, which means:
- Respect is the foundation for communication and action.
- Patient safety is our first priority.
- In being effective stewards of the gift of human tissue.
- In creating and maintaining a company culture that encourages and rewards honesty, openness, passionate debate – and fun!
- Individual ownership and empowerment lead to superior team results.
- The organization, its members and partners must consistently achieve agreed upon results with flexibility and mutual support.
- Speed is critical!