Director, Clinical Program Management

Role Summary

The Director/Senior Director of Clinical Program Management will work closely with multiple functional leads in the planning, execution, and delivery of key assets, initially focusing on Liquidia’s L606 and Yutrepia programs. This role will provide strategic leadership and steer internal and external stakeholders to a common goal, playing a large role in bringing transformative therapies to market.

Responsibilities

• Develop and implement cross-functional development plans at both a strategic and tactical level. Understand functional interfaces and drive cross-functional alignment to achieve corporate milestones
• Escalate risk effectively to senior management, while also developing and implementing mitigation strategies.
• Ability to consistently think of the bigger picture, so that commercial viability of development programs is adequately assessed throughout the product life cycle.
• Facilitate regular team and cross-functional meetings, develop dashboards, and provide status updates to senior management.
• Assist with the budgeting process, tracking study and operational budgets to ensure efficient allocation of resources across projects.
• Monitor evolving regulatory requirements as well as key milestones of competitors to ensure proactive planning.

Qualifications

• Bachelor’s degree and a minimum of 12 years of relevant experience with a focus on matrix management. Advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.
• Experience with program management from IND to NDA/BLA and global launch including a solid understanding of global registration processes. Experience with Phase 4 studies is also preferred.
• Experience in biotech/pharmaceutical industry with a demonstrated understanding of cross-functional interdependencies (i.e., R&D, commercial, technical development, regulatory)
• Experience supporting combination device programs, inhaled technologies and/or small molecules is strongly preferred.
• Experience with PAH, IPF, or other rare diseases is highly preferred.
• Demonstrated ability to lead, motivate, influence without authority a strategic direction; ability to effectively leverage and develop diverse perspectives and ideas from matrix teams and others.
• Excellent communication, negotiation, problem solving and decision-making abilities.
• Demonstrated ability to identify critical program risks and develop mitigation plans – strategic or tactical to mitigate risk, and costs.
• Demonstrated technical experience and success supporting clinical-to-commercial transitions in small molecule and inhaled combination products.
• Proven experience managing complexity in global programs across multiple modalities.

Education

• Bachelor’s degree; advanced degree (MS, PhD, MBA) preferred in a relevant biopharmaceutical discipline.