Note: The job is a remote job and is open to candidates in USA. Savara Inc. is a clinical-stage biopharmaceutical company focused on rare respiratory diseases, and they are seeking an Associate Director/Director of Project Management. This role provides project management support for the clinical organization, ensuring coordination of activities and deliverables for clinical development, 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
Skills
- 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
Benefits
- Highly competitive medical, dental, and vision coverage
- Flexible Spending Accounts for health care and dependent care expenses
- Paid time off and paid holidays, including Dec 24-Jan 1
- Paid parental leave
- 401k with highly competitive match
- Life, AD&D, STD and LTD insurance coverage
Company Overview