Assoc. Dir. or Director, Clinical Project Management (remote US)

Savara Inc. is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Associate Director/Director, Project Management will provide project management support for the clinical organization, ensuring coordination of activities and deliverables within Clinical Development, Clinical Operations, Pharmacovigilance, and Data Management.

Responsibilities:

• Serve as an operational extension of the CMO — tracking open items, driving decisions to closure, and ensuring organizational commitments are executed
• Synthesize CMO materials, agendas, and executive summaries for leadership meetings, board interactions, and external engagements
• 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 deliverables
• 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 operational project management for ongoing and planned clinical trials
• 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
• Coordinating with Regulatory team on regulatory interactions and commitments/deliverables related to these trials
• 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
• Keep the CMO informed of emerging issues. 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 and coordination across the organization (i.e. helping to build out roadmap/budget by facilitating SME discussions and inter-department alignment)
• Other duties and projects as assigned

Requirements:

• BA/BS degree with at least 5 years of project management experience and proven project management skills (preferably with focus on clinical development 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
• 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 SmartSheet
• CAPM or PMP certification preferred