Associate Director, Project Management (Clinical)- REMOTE US

Savara Inc. is a clinical stage biopharmaceutical company focused on rare respiratory diseases, and they are seeking an Associate Director of Project Management. This role is responsible for managing clinical inspection readiness and supporting key clinical initiatives, ensuring activities are completed on time and within budget.

Responsibilities:

• Provide PM support of key clinical initiatives, including:
• Clinical trial operations
• Global Health Authority inspection readiness planning and execution
• Manage contract and negotiations for clinical vendors
• Coordinate various cross-functional meetings to ensure alignment within the clinical team and between clinical, QA, and regulatory to ensure compliant and successful execution of project initiatives
• Leverage PM tools to track key activities and drive accountability on cross-functional activities, including:
• Risk management
• Corrective and Preventative Actions (CAPA) management and resolution
• Trial Master File (TMF) Filing and related study documentation
• Tasks related to Clinical Research Organization (CRO) oversight/management
• Responsible for project management efforts to support key clinical operations activities
• Specifically, oversee IMPALA-2 and IMPACT operational project management
• Ensuring close collaboration with the CRO and implementing consistent tracking and monitoring of site- and project-specific activities, including day-to-day management of projects as required, informing team members on progress, directing follow-on work
• Responsible for overall relationship management with specific external parties supporting the Clinical team
• Includes oversight of activities and delegation of activities and deliverables for vendors and contractors
• Ensure clinical project priorities, risks, and decisions are communicated to leadership
• Proactively identify risks and partner with cross-functional leads to develop mitigation plans
• Actively support longer term planning (i.e. helping to build out roadmap/budget by facilitating SME discussions and connecting dots
• Other duties and projects as assigned

Requirements:

• BA/BS degree with at least 5 years of global clinical trial management experience (preferably late stage programs)
• Strong experience in management of CROs and other vendors
• Knowledge of International Conference of Harmonization (ICH)/Good Clinical Practice (GCP) guidelines
• Strong knowledge of protocol and clinical drug development, processes, clinical study design, study planning and management, and monitoring
• Proven project management skills and study leadership ability with 2 years of direct PM experience
• Ability to multi-task and work in a fast paced cross-functional team environment
• Excellent interpersonal, written and verbal communication skills, and administrative ability
• Proficient computer skills in MS Word, PowerPoint, Excel, Project and trial management systems
• CAPM or PMP certification preferred