Executive Medical Director Clinical Development

3 weeks ago


Chicago, United States Rbw Consulting Full time

RBW is partnered with a large pharmaceutical company that is looking to looking to expand their late phase clinical development team.

Job Summary

Our client is looking to hire an experienced Executive Medical Director Clinical Development who is interested in a global development leader / clinical lead role. This person will oversee at least two studies in either lung, ovarian, or colorectal cancer, including a pivotal study. This role will report directly to the SVP and will be responsible for the development of clinical research strategies and direction.

Job Responsibilities

  • Expertise in medical and scientific fields is crucial for the success of clinical trials and development of effective treatments.
  • Provide clinical and scientific input for study design, protocol concepts, statistical analysis plans, and reporting to ensure valuable clinical endpoint insight for future decision-making.
  • Sound scientific and clinical judgement is essential to interpret clinical trial data accurately.
  • Collaboration with external opinion leaders, Principal Investigators, and clinical operations personnel is necessary for successful implementation of appropriately designed studies.
  • Developing scientific relationships with external opinion leaders and presenting at advisory boards, scientific meetings, and external committee meetings.
  • Participate in the preparation of abstracts, manuscripts, and presentations for external meetings and author clinical sections of regulatory documents (IB, IND sections).
  • Support the development of regulatory documents for filings and agency meetings and participate in interactions with regulatory agencies to ensure compliance.

Qualifications

  • MD or Equivalent
  • 5+ years of clinical development experience within the pharmaceutical industry.
  • Experience in oncology with deep experience in either ovarian, NSCLC, or colorectal clinical trials.
  • Late phase experience.
  • Experience as a global development lead.


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