Global Head of Clinical Development

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

Job summary

Vertex Pharmaceuticals is seeking an Executive Medical Director, Clinical Development to guide high-level clinical development strategies for povetacicept renal programs, coordinating with Medical Affairs, Regulatory, and other functions.

You will initiate innovative approaches, provide project team recommendations, and oversee global development activities while leading a team and ensuring compliant execution of studies and safety monitoring.

Qualifications

• MD, DO or equivalent ex-US medical degree
• 15 years pharmaceutical industry experience, including time managing clinical trials and/or clinical development program(s)
• 7 years of management experience #LI-JM1

Responsibilities

• Provide clinical development recommendations to project teams, including optimizing study design and conduct for efficiency and effectiveness.
• Participate in planning for worldwide clinical development activities.
• Provide guidance to multi-disciplinary development teams.
• Review study protocols, Investigator Brochures, and study subject exemptions.
• Oversee medical monitoring of clinical studies and evaluate adverse events and safety profiles.
• Interface with international regulatory authorities to support development objectives and ensure compliance.

Skills

Global clinical research

Regulatory experience

INDs/NDAs filing

Biostatistics knowledge

Clinical operations

Leadership/people management

Education

MD/DO or equivalent

Job description

Vertex Pharmaceuticals is seeking an Executive Medical Director, Clinical Development to guide high-level clinical development strategies for povetacicept renal programs, coordinating with Medical Affairs, Regulatory, and other functions.

You will initiate innovative approaches, provide project team recommendations, and oversee global development activities while leading a team and ensuring compliant execution of studies and safety monitoring.