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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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Cambridge, MA

Calling all job seekers! Discover exciting job opportunities in and around Cambridge, Massachusetts, a vibrant city known for its rich history, world-renowned universities like Harvard and MIT, and innovative tech scene. Cambridge offers a unique blend of academic excellence, cultural diversity, and a thriving arts community, with attractions like the iconic Harvard Square, the charming Charles River Esplanade, and the prestigious American Repertory Theater. From savoring local specialties like clam chowder and lobster rolls to cheering on the Red Sox at Fenway Park, there's something for everyone in this dynamic region. Explore job listings today and kick-start your career in this captivating area!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.