Associate Director, Project Management (Clinical)

Role Overview

The Associate Director, Project Management reports to VP, Business Operations and Head of Project Management. This role supports clinical inspection readiness, ensuring sustained audit and inspection preparedness activities are tracked and monitored across clinical programs. The person in this role is responsible for managing detailed aspects of clinical workstreams to ensure activities and deliverables are completed on time, within budget, and according to the clinical development plans.

Core 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
• Responsibile 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

Required Qualifications

• BA/BS degree with at least 5 years of global clinical trial management experience (preferably late stage programs)
• CAPM or PMP certification preferred
• 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

Work Schedule and Location

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

Savara provides Comprehensive Benefits including

• Highly competitive medical, dental, and vision coverage
• Flexible Spending Account for health care and dependent care expenses and Health Savings Account
• Paid time off and paid holidays, including Dec 24-Jan 1
• Paid parental leave
• 401(k) with highly competitive match
• Life, AD&D, STD and LTD insurance coverage

Savara’s compensation for this role will include a base salary, bonus, and equity. The base salary range for this role is $140,000 to $160,000.

About Savara

Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. The company's lead program, molgramostim nebulizer solution, is in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP). Savara's management team has extensive experience in rare respiratory diseases and pulmonary medicine, advancing product candidates to approval and commercialization.