Medical Director

5 days ago


Cambridge, Massachusetts, United States ONO PHARMA USA Full time
Job Title: Medical Director

ONO PHARMA USA is seeking a highly skilled Medical Director to lead our clinical development programs and associated clinical trials. As a key member of our team, you will be responsible for ensuring the highest medical integrity and conduct of clinical studies in the execution and completion of the clinical and regulatory components of the program.

Key Responsibilities:
  • Develop and implement strategic plans to enhance and streamline programs in the Clinical Development organization.
  • Collaborate with cross-functional teams to achieve organizational alignment and collective decision-making on approach and achievement of corporate objectives.
  • Represent the organization at high-level external meetings and ensure effective communication of technical information across the organization.
  • Ensure all clinical development plans, protocols, reports, publications, and regulatory documents are of the highest quality and scientific, operational, and ethical standards, in compliance with external regulations, and completed on time.
  • Develop proactive strategies to prevent risk and promote safety of patients enrolled in investigational trials.
Requirements:
  • Medical Degree (M.D.), possessing medical expertise in the therapeutic area of oncology or non-oncology is required.
  • 5 to 7 years of in-depth knowledge and clinical development experience within the pharmaceutical or biotechnology industry, or 7 to 9 years clinical trial experience in an academic setting, collaborating with pharmaceutical sponsors.
  • Experience as a Clinical Development Medical Monitor providing clinical leadership, strategic medical input, and medical evaluation of safety data for all clinical deliverables.
  • Experience working with regulatory bodies and creating scientific methodology for unbiased and well-controlled experimental design, methodology, analysis, interpretation, and reporting of study results.
Working Conditions:

The noise level in the work environment is usually quiet. This role requires the incumbent to travel up to 30% of the time.


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