Executive Medical Director

US-MA-Watertown
1 month ago(12/8/2017 10:46 AM)
Job ID
2017-1084
# of Openings
1
Category
Clinical Development

Overview

Under the general guidance of the Chief Medical Officer, this position will be responsible for all aspects of clinical development programs for drug candidates, including: overall program goals; design of clinical trials to meet program goals; medical monitoring of the clinical trials; and internal and external program communications (e.g., with clinical experts and global regulatory bodies). Lead a multi-disciplinary matrix team through highly complex decisions.

Responsibilities

  • Drives clinical science activities relating to the preparation/approval of synopses, protocols and the conduct of clinical studies
  • Analyze and interpret data, and clearly communicate results both internally and externally
  • Ongoing medical monitoring of clinical trials
  • Contributing to, reviewing, and approving clinical regulatory documents (clinical study reports, regulatory submission sections, investigator’s brochures, etc.)
  • Directs activities involved in interactions with regulatory authorities / agencies and clinical development activities undertaken to establish and maintain strong relationships with key opinion leaders. These responsibilities include leadership roles in meetings with the regulatory organizations or key opinion leaders, establishment of strategy.
  • Serves as primary interface with internal stake holders as well as external KOLS and Regulatory authorities for assigned programs.
  • Accountable for production of highest quality clinical elements of study, program, and Regulatory documents including protocols, IBs, briefing documents, and drug labels.
  • As business needs require, provides technical evaluation of business development activities for proof of concept stage acute anti-infective assets, working collaboratively with Medical Affairs and Medical Writing, Drug Safety, Clinical Operations, Commercial, and Regulatory Affairs
  • May be responsible for the management of clinical development staff, including performance management and professional development.

Qualifications

Education & Experience:

  • M.D. or D.O. and at least 5-7 years of experience in the pharmaceutical industry with specialization in infectious diseases.
  • Five to ten years years of experience in anti-infective clinical research, including expereince in development of anti-biotics.
  • Experience in both large and small companies a plus.
  • Experience and understanding of the design of clinical studies and protocols.
  • Direct experience in preparation of sections of regulatory filings and in dealings with regulatory agencies.
  • Experience in overseeing the effective execution of clinical research programs.

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