Associate Director, Project Management (Clinical)

Role OverviewThe 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 ResponsibilitiesProvide PM support of key clinical initiatives, including:Clinical trial operationsGlobal Health Authority inspection readiness planning and executionManage contract and negotiations for clinical vendorsCoordinate 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 initiativesLeverage PM tools to track key activities and drive accountability on cross-functional activities, including:Risk managementCorrective and Preventative Actions (CAPA) management and resolutionTrial Master File (TMF) Filing and related study documentationTasks related to Clinical Research Organization (CRO) oversight/managementResponsible for project management efforts to support key clinical operations activitiesSpecifically, oversee IMPALA-2 and IMPACT operational project managementEnsuring 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 workResponsibile for overall relationship management with specific external parties supporting the Clinical teamIncludes oversight of activities and delegation of activities and deliverables for vendors and contractorsEnsure clinical project priorities, risks, and decisions are communicated to leadershipProactively identify risks and partner with cross-functional leads to develop mitigation plansActively support longer term planning (i.e. helping to build out roadmap/budget by facilitating SME discussions and connecting dotsOther duties and projects as assignedRequired QualificationsBA/BS degree with at least 5 years of global clinical trial management experience (preferably late stage programs)CAPM or PMP certification preferredStrong experience in management of CROs and other vendorsKnowledge of International Conference of Harmonization (ICH)/Good Clinical Practice (GCP) guidelinesStrong knowledge of protocol and clinical drug development, processes, clinical study design, study planning and management, and monitoringProven 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 environmentExcellent interpersonal, written and verbal communication skills, and administrative abilityProficient computer skills in MS Word, PowerPoint, Excel, Project and trial management systemsWork Schedule and LocationThis 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 coverageFlexible Spending Account for health care and dependent care expenses and Health Savings AccountPaid time off and paid holidays, including Dec 24-Jan 1Paid parental leave401(k) with highly competitive matchLife, AD&D, STD and LTD insurance coverageSavara’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 SavaraSavara 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.

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