Our client is a biopharmaceutical company. They have asked us to assist them in their search for a Director, Project Management.
Major tasks and responsibilities include :
- Directs the project planning efforts for assigned projects in the US and EU in defining and implementation of the project strategy and operational plan by managing the creation of the operational plan and formulating the project scope, project plan, and critical paths with the Project Team and the Senior Leadership team.
- Ensures all partners meet company global project deliverables and guarantees excellence of project delivery on-time and on-budget.
- Independently identifies and drives project and resource priorities to align with the business objectives. Establishes, communicates, and executes plans that drive toward goal achievement.
- Provides clear direction and obtains buy-in of all team members to Integrated global development plan commitments.
- Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
- Directs the identification and escalation of potential issues / risks or obstacles and achieves resolution independently.
Plans contingencies and follows issues through to resolution ensuring that all issues arrive at a singular conclusion or recommendation with limited guidance from Senior Leadership.
- Oversees and manages a drug development budget of varying size and scope in all phases of drug development projects.
- Tracks and monitors program objectives / goals.
- Participates in the portfolio analysis process to ensure accurate information and timelines are completed to support project recommendations to Senior Leadership.
- Works with Regulatory Affairs to effectively manage timely completion of clinical trial applications, HA interactions and end of Phase II meetings.
- Utilizes project management tools to ensure timely execution of all activities related to clinical milestones, proactively identifies critical path activities, and allocates resources to mitigate bottlenecks.
We seek candidates with the following qualifications :
- A Bachelor’s degree in science or math is required. A Master’s degree and or project management certification is preferred.
- Must have 7-10 years of drug development experience in Clinical Research, Regulatory, CMC, or BDM or development related function.
Previous clinical research experience in Phase I-IV is preferred.
- Must have at least 5 years of project management experience leading complex projects in a multi-disciplinary, global environment.
- Must have a minimum of 3-5 years of people management experience and / or proven leadership experience in managing a global, matrix team.
- Proven leadership skills and strategic problem-solving ability are required.
- Requires demonstrated leadership skills managing matrix teams, influencing outcomes and key project decisions.
- A proven ability to communicate and collaborate effectively with senior management is required.
- Must have thorough knowledge of global drug development, QA, manufacturing operations, clinical and regulatory functions.
- The ability to read, analyze and interpret scientific and technical information and data is required.
- Excellent English communication skills, both verbal and written, are required.
- Requires the ability to apply mathematical concepts to such tasks as budgeting, cash flow, forecasting, probability analysis, statistics, and scenario planning to support corporate planning process.
- Must have the ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
- Must be able to define problems, collect data, establish facts, and draw valid conclusions.
- Requires the ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables.
- Must have a knowledge of PC software, including Microsoft Office products.
- Must be able to travel domestically and internationally on a reasonably frequent basis, approximately 15-20% of the time including some weekend travel.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
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