Senior Nonclinical Program Lead, Late-Stage Development

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 156,000 - 234,000; Full time

Benefits offered by this job

Annual bonus

Equity awards

Total Rewards

Job summary

Vertex Pharmaceuticals Inc (US) is seeking an Associate Director, Nonclinical Sciences Program Management & Strategic Operations to lead complex nonclinical development programs and manage regulatory submission activities. The role reports to senior leadership and collaborates with Regulatory Affairs, CROs, and cross-functional experts.

You will develop integrated project plans, forecast budgets, and ensure milestones are met on time and within budget, while driving risk management and executive

Qualifications

• Bachelor's degree in a scientific discipline or related field.
• Typically requires 10+ years of relevant experience in pharma/biotech/life sciences.
• Experience in program management and regulatory submission execution across NDA/BLA.

Responsibilities

• Lead cross-functional teams supporting major nonclinical development programs.
• Develop and maintain integrated project plans aligning deliverables with timelines.
• Forecast and manage program budgets and resource needs; oversee direct reports.
• Coordinate planning, authoring, review, and submission of regulatory documents for NDA/BLA.
• Partner with Regulatory Affairs, CROs, and external collaborators on submissions.
• Provide status reporting, risk management, and issue escalation to senior leadership.

Skills

GLP regulations

Nonclinical drug development

Regulatory submission planning

Cross-functional coordination

Project leadership

Excellent communication

Education

Bachelor's degree in a scientific discipline

Job description

Vertex Pharmaceuticals Inc (US) is seeking an Associate Director, Nonclinical Sciences Program Management & Strategic Operations to lead complex nonclinical development programs and manage regulatory submission activities. The role reports to senior leadership and collaborates with Regulatory Affairs, CROs, and cross-functional experts.

You will develop integrated project plans, forecast budgets, and ensure milestones are met on time and within budget, while driving risk management and executive