Job Scope & Purpose:
Having recently placed the Chief Medical Officer, our long-term client has retained us exclusively to find a world-class Medical Director. Our client has their own potentiator, corrector, as well as amplifier (first triple for CF). The Medical Director will serve as the Medical Lead for clinical trials, working with cross-functional study teams on clinical trial design and execution of clinical studies, protocol development, and filing and submitting documentation with the FDA. This individual will work on multiple trials in Phases 1 through 3 and may also participate in selected projects in earlier programs.
A compelling opportunity:
Ground floor position, with an outstanding C-level management team.
This is a highly visible position within an organization that is well-position to be the global leader in disease-modifying therapeutics for cystic fibrosis, genetic diseases and neurodegenerative diseases.
Faced-paced, team based environment.
Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key study documents in conjunction with other line functions and with minimal guidance
Serves on cross-functional study teams for assigned trials, working with other team members to achieve efficient, high-quality study execution
Participates in the preparation of regulatory documents in support of regulatory submissions, including clinical section of IND’s and CTA’s, IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/IRBs, and other documents as appropriate
Provides scientific and clinical input to study-related documents and analysis plans including Informed consent forms, clinical research forms, statistical analysis plans, and clinical study reports
Acts as liaison between Clinical Development and other internal groups for assigned studies
MD, DO or equivalent ex-US medical degree (non-MD candidates with doctoral degrees may be considered if they have an appropriate background in a clinical field)-
At least 8 years of clinical research experience in an academic or industrial setting, with experience in analysis of research data and publications; working knowledge of biostatistics and pharmacokinetics; working knowledge of GCP, scientific and clinical research methods and clinical study design, regulatory requirements for clinical studies
Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
Must have prior “lungs” experience - pulmonary, Cystic Fibrosis, respiratory, experience.
Position is based in Boston.
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