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

Key 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, and project management efforts to support key clinical operations activities
• Oversee operational project management for ongoing and planned clinical trials. Ensure close collaboration with the CRO and implement 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
• Carefully coordinate with the 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, including 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

Required Skills And Experience

• BA/BS degree with at least 5 years of project management experience and proven project management skills (preferably with focus on clinical development programs)
• CAPM or PMP certification preferred
• Strong experience in management of CROs and other vendors
• Strong 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
• Excellent interpersonal, written and verbal communication skills, and administrative ability
• Proficient computer skills in MS Word, PowerPoint, Excel, Project, and SmartSheet

Pay

The salary range for this role is $145,000 through $185,000.

Schedule and Location

This role is remote within the US and requires availability to work in the US Eastern Time Zone. Periodic face-to-face meetings at headquarters (in Langhorne, PA) or occasionally with US based partners will be required.

About Savara

Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. Our lead product candidate, MOLBREEVI*, is an inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). MOLBREEVI is delivered via a proprietary investigational eFLOW® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of MOLBREEVI. Our management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. Our goal is to become a leader in rare respiratory disease therapeutics through the development and commercialization of novel, best-in-class medicines that address unmet medical needs in this field.

Equal Opportunity Employer

Savara is an equal opportunity employer.