Director, Clinical Project Management

  • location: Waltham, MA
  • type: Contract
  • salary: $90 - $100 per hour
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job description

Director, Clinical Project Management

job summary:




The Director of Project Management provides project leadership to cross-functional teams in the successful delivery of all phase drug development projects or sub projects within a major development program. These responsibilities include leadership of the team in predicting and planning solutions to achieve successful operational execution; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making on projects. This position will have a high level of interaction with Senior Management to ensure that the scientific strategy is clearly integrated into operational plans.?



 
location: Waltham, Massachusetts
job type: Contract
salary: $90 - 100 per hour
work hours: 9 to 5
education: Masters
 
responsibilities:
  • Leads the planning efforts for assigned development programs in defining and implementation of Project Team strategy and operational plans.
  • Manages the operational plan and formulates the project scope, project plan, critical paths and risk-mitigation strategies with the Project Team and the Senior Management team.
  • Identifies and drives project and resource priorities that align with the business objectives that identify ways to accelerate the project execution where possible while maintaining high quality standards.
  • Develops strong logistical skills to manage activities across functions and regions.
  • Manages the identification and escalation of potential issues/risks or obstacles and achieves resolution or plans contingencies and follow issues through to resolution ensuring that all issues arrive at a singular conclusion or recommendation.
  • Establishes, communicates and executes plans that drive toward goal achievement.
  • Generates collaboration, cooperation and communication across functions teams to achieve stated goals.
  • Responsible for setting and managing expectations, highlighting and resolving issues, ensuring regular communications and managing internal and external activities. Facilitates the system to track and monitor program objectives/goals.
  • The scope of responsibilities extends from early clinical development through commercialization and post-marketing commitments.
 
qualifications:
  • Requires a Master's degree and a minimum of 5-7 years' experience as a project manager leading complex pharmaceutical projects in a multi-disciplinary, global environment. PhD, MD or PharmD a plus.
  • Extensive drug development experience with biologics in Phase 1-IV and Commercialization is preferred.
  • Proven leadership experience in managing a global, cross-functional team with demonstrated skills in strategic planning, risk mitigation, and operation problem solving.
  • Solid working knowledge of functional IND, BLA and NDA components/requirements required. Ideal candidate has worked on a program(s) that lead to successful regulatory approval (i.e., NDA, BLA, MAA, or SNDA).
  • Excellent verbal, written, and organizational communication skills.
  • Proficient in Microsoft Office including Word, Excel, PowerPoint, Microsoft Project and Outlook
 
skills: Phase iii
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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