The BLA Program Manager will lead the BLA core team. This individual is responsible for the overall coordination and management of the Biologics License Application (BLA) program for Axogen products. This role will provide management, organization, planning, execution, control, evaluation, and oversight to ensure organizational readiness to deliver BLA submission within scope, timeline, and budget. The BLA Program Manager will be accountable for ensuring all BLA workstreams achieve established milestones leading to a successful and timely BLA submission. The BLA Program Manager will participate in FDA interactions and meetings and will work closely with regulatory for development and submission of FDA briefing packets. The BLA Program Manager will develop a communication plan and manage project communications including providing updates to Executive Team and Sr. Leadership Team.
The BLA Program Manager reports directly to the Director, Program Management and works closely with the Executive Sponsor of the BLA. In addition to managing the BLA program this individual will support Axogen's program management group in development and implementation of PM systems, processes and templates.
Job Responsibilities: The specific duties of the BLA Program Manager include but are not limited to
- Provide program leadership. Responsible for all aspects of the BLA program including organization, identification of gaps, prioritization, resourcing, planning, execution, and closing all projects required to deliver a successful BLA
- Work with the BLA core team and workstreams including but not limited to Regulatory, CMC, Facility, Clinical to develop project plans that delineate team objectives, activities, timelines, and resources required to ensure consistency across the program
- Communication is critical- drive alignment within workstreams and team members and provide timely and targeted updates to the Sr. Leadership and Executive team
- Ensure milestones and goals are met on time, within scope, and within budget. Quickly recognize and raise issues and recommendations to next level management. Pro-actively manage and resolve conflict.
- Identify program risks and develop and execute mitigation plan; partner with workstreams to ensure project level risks are identified and mitigated
- Engage with all relevant stakeholders to implement appropriate project tracking ensuring alignment across sub-teams with up-to-date reporting
- Create and manage annual BLA budget
Experience / Qualifications
- Bachelor of Science degree in a relevant engineering, technology, or scientific background is required.
- 5-7 years project management experience in tissue engineering or medical device at a minimum is required. Biologics or biopharma experience is preferred, CMC experience preferred, BLA/PMA experience preferred.
- PMP certification preferred.
- Demonstrated ability in effectively leading multiple mid to large scale projects and programs in medical device/biotech environment (product development, regulatory, clinical, quality, manufacturing, etc..)
- Strong aptitude to drive cross-functional teams in a fast-paced environment to achieve tangible results
- Experience with Microsoft Office including Microsoft Project is required; ProChain/Critical Chain Methodology experience is preferred
- Track record of achieving results via influence and working with others in a dynamic, matrix environment
- Must demonstrate strong interpersonal, conflict resolution and communication skills with various levels of management
- Must possess the ability to manage differences and needs between multiple stakeholders.
- Knowledge of biologics/drugs regulatory pathway is strongly preferred
- Experience in a clinical setting is strongly preferred.