Clinical Development Medical Director (Hybrid)

MFS Investments

Boston (MA)

Hybrid

USD 240,000 - 360,000

Full time

4 days ago

Be an early applicant

Get a reply from this employer

Your resume and cover letter, tailored to exactly what they’re hiring for.

Get past ATS filters

Job summary

Vertex is seeking a Clinical Development Medical Director to serve as the Medical Lead for multiple Phase clinical trials, overseeing strategy, design and execution, and acting as the Medical Monitor to ensure subject safety across trials. The incumbent will work on diverse trials and may participate in other clinical development projects.

The ideal candidate will have an MD/DO, 10+ years of research experience, board certification, and strong biostatistics/GCP knowledge.

Qualifications

MD, DO or equivalent ex-US medical degree.
Board certification/eligibility in a specialty field is highly desired.
Typically requires 10 years of basic or clinical research experience.
Working knowledge of biostatistics; GCP; clinical study design; and regulatory expectations.
Experience with design, execution, and analysis of clinical trials required

Responsibilities

Leads development of Study Protocols, Investigator Brochures and Clinical Development Plans.
Functions as Medical Monitor for assigned studies.
Participates in cross-functional Study Execution Teams for efficient study execution.
Contributes to regulatory documents for submissions (INDs/CTAs, safety reports).
Provides scientific input to CSRs, SAPs, CPAPs and ICFs; liaises with Regulatory Affairs and Clinical Operations.
Represents Vertex to outside medical personnel in protocol development and study conduct.
Performs other duties as assigned related to clinical programs.