Drug Development Project Management
Classification: contract position, 20-30 hours/week.
we require an experienced project manager (pm) to be responsible for overall project management of a biologic in preparation for filing of us ind as well as ex-us clinical trial applications. The pm will work with a number of expert consultants contracted to us and external service providers as integral parts of the drug development team.
Duties will include managing all operational aspects of the project including development and management of overall project timelines, meeting management (scheduling, agendas, minutes, action items follow-up), logistics support, contract and proposal development, document review cycles, coordination of multiple cmo schedules and activities. The pm will be accountable to the vp of operations.
The company headquarters is located in austin, texas; however, the position can be located in austin (no relocation benefit) or virtual. The pm must generally be available during working hours that support us time zones.
Essential duties and responsibilities:
-facilitate and provide hands-on support ensuring seamless handoffs and coordination among key functional areas
-prepare timely agendas and minutes for project team meetings and ensure completion of action items
-develop and maintain high level and detailed timelines of the project plan and through use of project management software tools, ensure that the functional resources and timelines are aligned with global project timelines
-provide support in resolving project issues by managing contingency planning and influencing risk mitigation strategies with input from the team
-actively communicate any discrepancies in project timeline, costs or quality to the vp operations; -anticipate and participate in the resolution of budget issues, timeline delays and/or competing priorities
-prepare project progress reports, identifying and anticipating issues that threaten a project’s adherence to the timeline and budget
-track functional area milestones (cmc, nonclinical, clinical, and regulatory) and sub-team activities to ensure overall adherence to the project plan and timeline
-support diligence by and management efforts of external auditors, investors and alliance partners as needed.
Education and experience:
-bachelor’s degree (life science degree preferred) and 3 – 5 years’ experience in project management in the biotech or pharmaceutical industry, preferably in a setting that includes management of multiple external vendors
preferred: advanced degree(s) (ms/ph.D. In life science, mba, pharmaceutics) and project management certification
knowledge of project planning software (e.G. Ms project, conceptdraw project/mindmap)
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