Phase 1 Early Development Medical Lead

MFS Investments; Boston (MA); Hybride; USD 204 000 - 306 000; Plein temps

Avantages offerts par ce poste

Medical, Dental, Vision benefits

Paid Time Off

Student Loan Repayment Support

Commuting Subsidy

401(k) Match

Educational Assistance

Résumé du poste

Vertex is seeking an Early Development Associate Medical Director to lead Phase 1 trials as the Medical Lead and internal Medical Monitor, overseeing safety and scientific integrity while collaborating across Research, Biomarkers, Regulatory Affairs and Global Clinical Operations.

Role involves cross-functional study execution, regulatory documentation, and liaison duties; requires MD/DO and 8+ years of research experience in academia or industry, with a hybrid work option.

Qualifications

• MD, DO or equivalent ex-US medical degree.
• Typically requires 8 years of basic or clinical research experience.

Responsabilités

• Participates in development of Study Protocols, Investigator's Brochures, Early Development Plans and other key documents.
• Serves on cross-functional Study Execution Teams (SET) for assigned trials.
• Prepares regulatory documents for regulatory submissions, including clinical sections of INDs/CTAs, safety reports and annual reports; responses to authorities.
• Provides scientific and clinical input to study-related documents and analysis plans.
• Acts as liaison between Early Development and other Vertex groups.
• Represents Vertex to outside medical personnel in protocol development, study conduct, and external reporting of results.
• Performs other duties related to Early Development.

Connaissances

Communication

Cross-functional teamwork

Regulatory experience

Biostatistics

Pharmacology

Pharmacokinetics

GCP knowledge

Study design

Manuscript preparation

Oral presentations

Formation

MD/DO or equivalent ex-US medical degree

Description du poste

Vertex is seeking an Early Development Associate Medical Director to lead Phase 1 trials as the Medical Lead and internal Medical Monitor, overseeing safety and scientific integrity while collaborating across Research, Biomarkers, Regulatory Affairs and Global Clinical Operations.

Role involves cross-functional study execution, regulatory documentation, and liaison duties; requires MD/DO and 8+ years of research experience in academia or industry, with a hybrid work option.