Medical Director Boston

Investigo is working with a cutting edge Boston based biotech firm who is looking for a long term contract Medical Director to join the team. In this role you will be working closely with the CMO and Head of Medical Development to design and lead clinical trials, author medical and scientific articles, and provide data analyses.

Key Responsibilities

• Support the CMO as the US/International clinical lead for program within Hepatology to both internally and externally facing stakeholders
• In conjunction with other relevant functional areas, help develop/ refine the strategic development plan
• Provide clinical and scientific expertise to the design of studies, writing of protocols, and other study and regulatory-related documents for program
• Participate in the analysis and interpretation of data, ensure integrity of trial data, and assist in reporting of study results including preparation of scientific summaries, abstracts and manuscripts
• Provide leadership in the execution of clinical trials
• Ensure compliance with SOPs, ICH, GCP and other national and international regulatory requirements
• Work with the CMO, Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive the timely completion of all clinical activities related to the program
• Interface with US/International regulatory authorities, as appropriate, in support of the development objectives and assist Regulatory Strategy staff in the compilation of submissions and in the responses to inquiries

Qualifications

• MD or the international equivalent is required
• Strong scientific background with experience in reviewing & interpreting scientific and study data is required
• Track record of scientific publications strongly preferred
• 1- 2 years of Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic research background
• Working knowledge of biostatistics, data management, clinical operations and scientific and technical processes desirable
• Working knowledge of applicable US and EU regulatory requirements and of the drug development process
• Experience in building and maintaining effective relationships with external KOL's, advisory boards and other key external therapeutic area influencers desirable
• Team player who works collaboratively in a challenging team matrix environment
• Ability to work independently to resolve challenges and conflicts

For more information on this opportunity or others in the area please email me at chris.pizarro@investigo-us.com or call at 8609782363