Summary of Position:The Associate Director/Director, Project Management reports to Chief Medical Officer. This role provides project management support for the clinical organization and includes workstreams within Clinical Development, Clinical Operations, Pharmacovigilance (PV), and Data Management. The person in this role is responsible for managing detailed aspects of clinical workstreams to ensure coordination of activities and deliverables so that they are completed on time, within budget, and according to the clinical development strategy. This role will be filled at the Associate Director or Director level.
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
- 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.
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
- 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
Work 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.
Savara provides comprehensive benefits including:- 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
Savara's compensation can include an hourly rate, bonus, and equity. This position will be filled at the Associate Director or Director level. The salary range for this role is $145,000 through $185,000.
*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication. MOLBREEVI is a trademark of Savara Inc.
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