Asklepios BioPharmaceutical (AskBio) is a privately held AAV gene therapy company founded in 2001 to advance the work of Jude Samulski, PhD, from the lab into the clinic. Dr. Samulski is the former director of the Gene Therapy Center at the University of North Carolina and was the first to clone AAV for therapeutic purposes. Today, AskBio has built itself into a fully integrated company with next-generation AAV and gene control technology, a broad patents and IP portfolio, scaled-up manufacturing, and clinical-stage therapeutic programs. We are headquartered in Research Triangle Park, North Carolina.
We have an opportunity for a Project Manager to join the AskBio team.
About the role:
The Project Manager/Sr. Project Manager possesses a comprehensive knowledge of drug development, advanced knowledge of scheduling and resource forecasting software (e.g., MS Project), as well as the definitions, standards and associated systems and tools, and may support several different types of schedules in a clinical development plan, which may include, but are not limited to: medicine, candidate/indication, clinical studies, end game/submission, and product launch planning. He/she plays a key role in scenario planning, i.e., building schedule/resourcing options and forecasting associated development costs that depict various development options. The Project Manager typically works within a cross-functional team environment but frequently leads/co-leads complex sub-team initiatives. He/she applies skills to support teams' operational/strategic delivery of new medicines to patients.
Organizational RelationshipsReports directly to a Program Leader. A colleague at this level is expected to work independently on most assignments, which typically involve complex problems and scenarios, using knowledge and work experience to achieve desired results. The Project Manager works primarily in a cross-functional or matrixed team environment and is expected to ensure his/her work meets expected standards with minimal review by team members or leadership.
Partners primarily with members of project teams and external collaborators to ensure accurate, integrated project planning at the medicine, indication and study level. The candidate will have a high level of awareness of his/her limits and judgment and is frequently a resource to peers, leadership and other colleagues.
Responsibilities and Accountabilities
Responsible for performing important project planning activities in support of team deliverables. To effectively execute the primary responsibilities, the Project Manager must possess an advanced knowledge of the principles, concepts and theories of project management. The colleague executes his/her role by partnering with the Project Leader in support of research, development, and clinical evaluation project team members to create project schedules that enable effective planning and ensure project delivery. The colleague is expected to apply technical proficiency along with advanced scheduling knowledge to contribute to the achievement of work team deliverables and goals.
Planning/Controlling (Scheduling & Resource Management)
- Responsible for coordinating, monitoring and reporting cross-functional project schedule information
- Identifies and raises schedule conflicts, risks and resource peaks/troughs appropriately for resolution
- Directly participates in and contributes to cross-functional and functional teams to discuss, review and optimize protocol/project/program schedules and resource management plans
- Monitors progress of project activities toward next project milestone, anticipates and highlights potential variances, supports line/team in critical path analyses and understanding the impact
- Partners with Clinical Operations and the project team to identify/recommend solutions to schedule risk
- Performs scenario planning of project timelines within and across protocols and therapeutic area/portfolio to enable optimum use of local, global and outsourced resources to ensure efficient delivery of project milestones
Project Execution & Delivery
- Partners with key team members to manage the project and achieve key milestones according to the endorsed timeline, cost and quality parameters
- Supports negotiations in the allocation of line resources to support the endorsed development plan
- Contributes to risk management through the identification of operational and project/program risks for discussion with appropriate team leadership. Participates in team discussions to de-risk projects and develop new options to resolve moderately complex issues
- Manages program budgets through the oversight of external vendors and internal spend and contributes toward program level annual budget development
Analysis & Reporting
- Produces what-if scenario analyses (base, optimistic and pessimistic development) based on context obtained from project team members. Decisions taken by the team based on these analyses may impact project delivery, costs, and resource requirements
- Reviews own work regarding quality of schedule and resource metadata through utilization of quality reports and monitoring/management of such data with the team
- Provides timely reporting to the project teams, alerting them to the possibility of endangered/missed or conflicting milestones and critical path activities
- Ensures regular information updates and analysis and interpretation of planning and forecasting data to project teams and management teams
- Uses available reporting and visualization tools to support governance and team reporting needs)
- Partners with project team members to identify opportunities and potential solutions to realize efficiency in the development process
- Contributes to continuous improvement of project plans, plan generation, plan utilization, report creation/development processes, and/or systems/process integration
- Collaborates with colleagues to ensure cross-team, site learnings and best practices are shared
- Promotes partner lines/teams taking ownership of data within planning tools to help them manage their business
- May provide training and mentorship to new and established users of planning systems, including the associated operating procedures and reporting
- Bachelors-level degree
- BS with 5+ years' experience or MS with 3+ years' experience
- At least 3 years of applicable experience in project planning and project management
- At least 5 years of applicable pharmaceutical industry experience
- PhD preferred, but not required
- Cardiovascular experience required
- Experienced with planning and resource forecasting tools (e.g., MS Project)
- Experienced user of reporting and office software (e.g., MS Office, Business Objects, Spotfire)
- Trained/experienced in negotiation, facilitation and managing cross-functional team dynamics
AskLife: We offer a competitive total rewards package. Are you our next great discovery?