Director, Portfolio Excellence & Process Standards

CSL Plasma; Waltham (MA); Hybrid; USD 230,000 - 270,000; Full time

Benefits offered by this job

Equity

Incentive compensation

Job summary

CSL Plasma is seeking a Director, Portfolio Development Process & Standards Lead to establish a global framework for planning, evaluating, and reporting clinical programs. The role demands extensive PD expertise, SOP governance, and cross-functional leadership across sites in the US, UK, and beyond.

You will drive training curriculum development and change management, partnering with PM/PD leadership to ensure high-quality standards and streamlined processes across the organization.

Qualifications

• 12+ years experience in biotechnology or pharmaceutical industry.
• 5+ years managing Clinical Research and Development projects, including trials.
• 3+ years leading process-improvement initiatives and driving change.
• Proven cross-functional, multicultural, international collaboration.
• In-depth knowledge of drug development and GCP environment.

Responsibilities

• Establish and maintain a framework for planning, evaluating, and reporting trials and programs.
• Lead SOP updates and partner with SMEs to reflect current processes.
• Develop a fit-for-purpose PD training curriculum supporting quality goals.
• Guide stakeholders on procedural expectations and change management.
• Drive excellence through cross-functional initiatives and systematic design.
• Represent Portfolio Development in cross-functional R&D forums.

Skills

Portfolio Development

Process Improvement

Change Management

Stakeholder Management

Cross-functional Leadership

Training Curriculum Development

Education

Bachelor's degree in life sciences

Job description

CSL Plasma is seeking a Director, Portfolio Development Process & Standards Lead to establish a global framework for planning, evaluating, and reporting clinical programs. The role demands extensive PD expertise, SOP governance, and cross-functional leadership across sites in the US, UK, and beyond.

You will drive training curriculum development and change management, partnering with PM/PD leadership to ensure high-quality standards and streamlined processes across the organization.