Clinical Development Director

1 day ago


Reston, Virginia, United States Biopretium Full time
{"title": "Clinical Development Director", "content": "Job Summary

Biopretium is seeking a highly experienced Clinical Development Director to lead the strategic direction, planning, and execution of clinical development programs. This role is responsible for overseeing the design and execution of clinical studies, ensuring compliance with medical and regulatory standards.

Key Responsibilities:

  • Lead the design and execution of clinical development programs, ensuring compliance with medical and regulatory standards.
  • Oversee the integrity and progress of clinical studies, ensuring the accumulation, analysis, and communication of data regarding the safety and efficacy of compounds.
  • Accountable for serious adverse event assessments and regulatory reporting.
  • Proactively monitor clinical trial safety, collaborating with safety teams to evaluate trial data and address safety concerns from investigators and regulatory bodies.

Requirements:

  • M.D. or equivalent degree.
  • Strong background in drug development, particularly in biologics within Oncology.
  • Proven leadership, decision-making, and communication skills, with the ability to work in a cross-functional team.
  • Expertise in the clinical development process, risk management plans, and regulatory requirements for global trials.

About Biopretium:

Biopretium is a biotech company founded in 2014 with headquarters in Washington state. We focus on the development of therapies for oncology indications and have a substantial pipeline with multiple assets in Phase 3 development.

", "lang_code": "en-US"}

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