Due to growth, we are actively looking to bring aboard a Clinical Drug Development Project Manager. The ideal background will have a minimum of 2 years project management experience (specifically in the drug development process) and strong Microsoft Project experience. Acting as the central point of contact for information about a specific asset, the Clinical Drug Development Project Manager manages the development activities. They also ensure alignment between management and the team to achieve outlined goals & objectives. Other key deliverables are to create development strategy, establish objectives and monitor team progress. Makes recommendations regarding project objectives, resource requirements, and scientific direction to the team and senior management.
- Provides professional program management for 2 or more complex development programs.
- Organizes, manages, and supports cross-functional compound-level project teams (including day-to-day team management and stakeholder interactions) toward implementation of the strategic and operational plans and tracks progress to goals.
- Develops and supports the maintenance of drug development plans (including timelines, milestones, deliverables, budgets, etc.) to ensure on-time delivery of the plan.
- Is responsible for maintenance of the project actions, risks, decisions, and issues. Maintains or oversees management of project schedules using Microsoft Project.
- Facilitates the review of development projects with Senior Management, makes recommendations for action and ensures appropriate follow-up by management to achieve approved objectives.
- Manages project information for assigned projects and is responsible for developing and maintaining good relationships with other functions.
- Is responsible for ensuring smooth transitions between action points.
- Supports quarterly forecasts, manages scopes, timeline, and financial changes through tracking variances at the program level.
- Works with relevant areas/teams to lead the development of strategy and project plan (inclusive of timelines, milestones, interdependencies, issues, risks, and actions).
- Manages and tracks program progress as assigned on a continual basis, identifying and tracking both cross-project and cross-functional issues, scope issues at the project and program level, timeline issues, and budget issues. Works proactively with the manager and the project team to achieve timely resolution of these issues in order to achieve approved program objectives.
- Is responsible for ensuring timely, accurate and comprehensive project and program information is available to senior management and the wider organization.
- Bachelor's degree in science or relevant field
- MBA desirable
- PMP certification desirable
- At least 5 years of pharma experience
- At least 2 years of project management experience
- Experience and sound working knowledge of the drug development process
- Awareness and familiarity regarding the execution of clinical trials, especially Phases II/III
- Experience and knowledge to assist teams to prepare for regulatory interactions, submission experience preferred but not required
- Sound working knowledge of Microsoft Project
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