Clinical Development Associate Medical Director- Generalized Myasthenia Gravis

Role Summary

The Clinical Development Associate Medical Director for generalized myasthenia gravis (gMG) serves as the Medical Lead for clinical trials, guiding strategy, design, execution, and reporting. They act as the internal primary Medical Monitor responsible for monitoring safety and ensuring scientific integrity across the study. The role may involve participation in other projects to support the clinical development program.

Responsibilities

• Participates in the development of Study Protocols, Investigator's Brochures, Clinical Development Plans and other key documents 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

Qualifications

• MD, DO or equivalent ex-US medical degree
• Typically requires 8 years of basic or clinical research experience in an academic or industry setting, or the equivalent combination of education and experience
• 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
• Preferred: Board certification/eligibility, as well as clinical training in a relevant medical specialty is highly desired