Job Description
General Summary :
The Clinical Development Associate Medical Director will serve as the Medical Lead for Type 1 Diabetes clinical trials, working with cross-functional teams on trial strategy, design, execution, and reporting.
In addition to oversight and accountability for the study as a whole, this role will serve as the internal primary Medical Monitor accountable for monitoring the safety of enrolled subjects and ensuring scientific integrity.
The incumbent may participate in other projects to support the clinical development program.
Key Duties and Responsibilities :
- Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents in conjunction with other line functions and with minimal guidance
- Serves on cross-functional Study Execution Teams (SET) 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 INDs and CTAs, 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, clinical pharmacology analysis plans, and clinical study reports
- Acts as liaison between Clinical Development and other internal groups at Vertex (e.g., Regulatory Affairs, Clinical Development Execution) for assigned studies
- Represents Vertex to outside medical personnel in the development of clinical protocols, in study conduct, and in external reporting of study results
- Performs other duties as assigned related to other aspects of Clinical Development
Knowledge and Skills :
- Strong oral and written communication skills
- Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate
- Global clinical research experience and experience interacting with regulatory authorities is a plus
- Working familiarity with analysis of research data, biostatistics, pharmacology and pharmacokinetics, international standards for Good Clinical Practice (GCP), clinical study design, ethics committee / Institutional Review Board review, preparation of manuscripts, abstract / posters, and oral presentations, overall drug / device clinical development
- Board certification / eligibility, as well as clinical training in a relevant medical specialty is highly desired
Education and Experience :
- MD, DO or equivalent ex-US medical degree
- Medical Residency in Endocrinology or experience in Type 1 Diabetes research or related field
- 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience
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