Global Medical Director, Clinical Development

Vertex Pharmaceuticals Incorporated; Boston (MA); Hybrid; USD 320,000 - 480,000; Full time

Job summary

Vertex Pharmaceuticals Incorporated seeks an Executive Medical Director, Clinical Development to provide high-level input on clinical development strategies for povetacicept renal programs, coordinating with Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, and Marketing.

Lead innovative approaches to development.

Qualifications

• Broad and comprehensive understanding of the drug development process.
• Experience interacting with regulatory authorities is highly desired.
• Proven ability to lead multi-disciplinary teams in a fast-paced setting.
• Familiarity with US and EU regulatory requirements and IND/NDA filings.

Responsibilities

• Provide clinical development recommendations to project teams and optimize study design.
• Oversee medical monitoring of clinical studies and evaluate safety.
• Interface with international regulatory authorities to support development objectives.
• Plan worldwide clinical development activities and guide multidisciplinary teams.
• Review study protocols and Investigator Brochures.
• Lead people management responsibilities including potential HR duties.

Skills

Clinical development

Regulatory interactions

Leadership

Study design

Biostatistics knowledge

Global collaboration

Education

MD/DO or equivalent ex-US medical degree

Job description

Vertex Pharmaceuticals Incorporated seeks an Executive Medical Director, Clinical Development to provide high-level input on clinical development strategies for povetacicept renal programs, coordinating with Medical Affairs, Regulatory, Global Patient Safety, Clinical Operations, Exploratory Development, Commercial, Pharmaceutical Development, Research, and Marketing.

Lead innovative approaches to development.