Medical Director/Senior Medical Director, Oncology

Alkermes   •  

Waltham, MA

Industry: Pharmaceuticals & Biotech

  •  

Not Specified years

Posted 175 days ago

This job is no longer available.

Clinical Development is composed of a “hands-on” group of dedicated professionals.  Team members work flexibly and collaboratively together in a matrix environment, with a high degree of personal accountability for the success of novel and aggressive clinical programs and timelines.  

Position Summary

This physician’s primary responsibility will be to advance the company’s immune-oncology program.  In addition, this physician will help advance early stage compounds into the clinic.

Key responsibilities for the Medical Director/Senior Medical Director include:

  • Accountability for the strategic planning and execution (including study design, method selection, etc) of Phase I through IV global clinical trials
  • Analyze and interpret data expertly, and clearly communicate results both internally and externally.
  • Oversee ongoing medical monitoring of clinical trials.
  • Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
  • Working collaboratively with Medical Directors, Biostatistics and Medical Writing, Drug Safety, Clinical Operations, Translational Medicine, and Regulatory Affairs.
  • Working with US and EU regulators.
  • Mentoring junior team members, and providing guidance and opportunity for their professional development.

 

Minimum Education & Experience Requirements:

  • MD with expertise in Oncology
  • A minimum of three years’ experience working in biopharma clinical development
  • A total of at least six years working in clinical research or clinical development, either in biopharma or academia.   
  • Direct experience interacting with regulatory authorities.

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