Clinical Development Associate Medical Director - Cystic Fibrosis

Role Summary

The Clinical Development Medical Director serves as the Medical Lead for Vertex clinical trials, collaborating with cross-functional study teams on trial strategy, design and execution, and acting as Medical Monitor to oversee safety of enrolled subjects across assigned trials. The role involves work on multiple trials across all Phases of clinical development and may include participation in other clinical development projects.

Responsibilities

• Leads development of Study Protocols, Investigator Brochures, Clinical Development Plans and other key study documents with minimal guidance
• Serves on cross-functional Study Execution Teams for assigned trials to achieve efficient, high-quality study execution
• Participates in preparation of regulatory documents supporting submissions, including clinical sections of INDs and CTAs, safety reports and annual reports, responses to regulatory authorities and Ethics Committees/IRBs
• Provides scientific and clinical input to study-related documents and analysis plans, and acts as liaison between Translational Medicine/Clinical Development and other internal groups
• Represents Vertex to outside medical personnel in the development of clinical protocols and study conduct
• Performs other duties as assigned related to clinical programs

Qualifications

• Board certification/eligibility in a medical, pediatric or surgical subspecialty
• MD, DO or equivalent ex-US medical degree; board certification/eligibility in a specialty field highly desirable
• Typically requires 10 years of basic or clinical research experience in an academic or industrial setting, or equivalent combination of education and experience
• Experience in analysis of research data and publications; working knowledge of biostatistics; working knowledge of GCP, scientific and clinical research methods and clinical study design
• Experience with design, execution, and analysis of clinical trials

Skills

• Excellent oral and written communication skills
• Ability to work collaboratively in a fast-paced, team-based, matrix environment and to function independently as appropriate
• Effective at building alliances across functions based on end-to-end drug development thinking and experience

Education

• MD, DO or equivalent ex-US medical degree