Phase 1 Medical Director, Early Development – Hybrid

Vertex Inc.; Boston (MA); Hybrid; USD 204,000 - 306,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Vertex Inc. is seeking an Early Development Associate Medical Director to serve as the Medical Lead for Phase 1 trials, guiding strategy, design, execution and reporting.

You will monitor safety and maintain scientific integrity across the study with cross-functional teams. The role also involves developing study protocols, regulatory submissions, and clinical analysis plans, collaborating with Regulatory Affairs and Global Clinical Operations.

Qualifications

• MD, DO or equivalent ex-US medical degree.
• Typically requires 8 years of basic or clinical research experience.
• Strong communication and collaboration across functions.

Responsibilities

• Participates in protocol development and key study documents with minimal guidance.
• Serves on cross-functional Study Execution Teams to ensure high-quality trial execution.
• Prepares regulatory submissions, IND/CTA documents, safety reports and annual reports.
• Provides medical input to study documents and analysis plans.
• Acts as liaison between Early Development and internal Vertex groups.
• Represents Vertex to external medical personnel in protocol development and reporting.
• Performs other duties related to Early Development.

Skills

Medical leadership

Cross-functional collaboration

Regulatory affairs interaction

Clinical trial design

Biostatistics familiarity

Education

MD/DO or equivalent ex-US medical degree

Job description

Vertex Inc. is seeking an Early Development Associate Medical Director to serve as the Medical Lead for Phase 1 trials, guiding strategy, design, execution and reporting.

You will monitor safety and maintain scientific integrity across the study with cross-functional teams. The role also involves developing study protocols, regulatory submissions, and clinical analysis plans, collaborating with Regulatory Affairs and Global Clinical Operations.