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Director, Program Team Lead

Cambridge, Massachusetts

Post Date: 11/29/2017 Job ID: 1662 Job Category: Clinical: R&D Program Management

Our client is seeking a Director, Program Team Lead. The right candidate will possess an in-depth understanding of the drug development process, and have experience ranging from manufacturing to product development and successful product commercialization. As a Program Leader, responsibilities and experience include leading cross functional program teams to develop and execute on drug development plans to register and commercialize drug candidates for rare diseases. The Program Team Leader is expected to develop the long-term plan for the program, contemplating regulatory and commercial expansion well beyond the path to initial approval. The position reports into the Senior Director of Program Management.

Job  Responsibilities:
  • Operational leader for one or more of current clinical development programs
  • Serve as visible program champion and focal point for critical program information
  • Develop an integrated, cross functional, multi-year plan for the program that contemplates both fast paths to initial approval and commercialization and also incorporates medium and long-term opportunities beyond the obvious first path
  • Lead cross-functional program teams to develop strategies and execute on lifecycle management plans to ensure R&D objectives are aligned with overall business strategies
  • Manage and deliver product integrated development plans and ensure alignment across strategic, operational and tactical plans
  • Drive decision making and associated deliverables across all functions of the team and contribute to the portfolio planning process on behalf of the program(s)
  • Establish and maintain integrated cross-project plans to enable accurate project, financial and portfolio analyses
  • Ensure accurate project, financial, and portfolio analyses are provided for planning processes and resource allocation
  • Manage financial budgeting and forecasting process, including long range planning and budget drivers
  • Perform full program planning, goal setting, and execution within team environment


Qualifications:
  • 10+ year of industry experience with 5+ years of leading and managing preclinical and clinical drug development programs
  • Bachelor’ s degree in life sciences with an advanced degree (MBA, MPH, MS, PhD, etc.)
  • Understanding of late-stage clinical development and pre-commercialization activities required
  • Drug development and approval process  experience with advanced knowledge of FDA, EMA and ICH regulations, industry standards and quality control principles
  • Experience with Compassionate Use Programs, Investigator Sponsored Trials, and transition of clinical programs to commercialization highly preferred 
  • Must be proficient in Microsoft Project, Word, Excel, PowerPoint, and Adobe Acrobat

 

Anna Korelis

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