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Medical Director I - Part Time

Cambridge, MA 02142

Posted: 04/08/2024 Employment Type: Contract Job Category: Medical Affairs Job Number: 604425 Is job remote?: Yes Country: United States

Job Description

Pay is commiserate with experience and ranges between $73-83/hr

Plans and directs all aspects of an organization's medical policies, standards, and programs. Responsible for strategic clinical relationships with physicians and interns. Ensures all clinical programs are in compliance with all applicable regulations. Researches and studies current medical publications and data on new treatments and practices to ensure high quality clinical service offerings. Advises non medical management on clinical and patient related matters and policies. Requires an advanced degree of in medicine. Manages a departmental function within a broader corporate function. Develops major goals to support broad functional objectives. Approves policies developed within various sub-functions and departments. Typically requires 8-15 years of managerial experience.

The Clinical Trial Physician will play a key role in a large global phase 3 lupus outcome study. In addition to the responsibilities described below, the CTP will be specifically responsible for reviewing participants medical conditions for study entry requirement . The tasks and activities of the Clinical Trial Physician will be carried out in close collaboration with the study Clinical Lead.

Responsibilities
• Providing medical leadership internally for the trial activities assigned, through a comprehensive understanding of the science, medicine, product environment and competitive landscape relating to a disease area
• Contributing to the core medical/scientific information required in all clinical documents of the respective trial (e.g. protocols, core informed consent forms, clinical study reports, safety related documents etc.) and assure production of high-quality documents
• Supporting the Clinical lead by:
• Delivering medical oversight of the study (including safety, medical review of data during the trial, quality and performance of the trial)
• Answering to trial-related EC/IRB and HA questions
• Delivering medical training to the study teams’ members and staff and protocol-related training to study sites
Requirements
• MD, Rheumatologist
• At least 2 years’ experience in clinical research in a Pharmaceutical and/or Biotech company or equivalent in Academia within lupus therapeutic area
• Experience in patient education is a plus
• Good knowledge of drug development and clinical trial process based on previous experience
• Good knowledge of regulatory requirements/ICH guidelines
• Good organizational and communication skills, able to work as part of a team and independently
• Results driven attitude and good sense of urgency
• Able to anticipate and proactively address issues and demands, solution oriented and hands-on
• Analytical thinking, data and detail oriented
• Shares knowledge and expertise openly
• Excellent written and spoken communication skills in English
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