Director, Portfolio Development Process & Standards Lead

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's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Could you be our next Director, Portfolio Development Process & Standards Lead? This position is located in our King of Prussia, PA Waltham MA or Maidenhead UK office. It is a hybrid role three days onsite. You will report to the Head, Porfolio Development Excellence, Process & Compliance. You will be responsible for establishing and maintaining a framework that allows the Global Portfolio Development group, in collaboration with multiple partner functions across the organization, to plan, evaluate and report clinical trials and programs under highest quality standards.

REQUIREMENTS

• Portfolio Development Excellence: Procedures, training, continued learning, and guidance
• Manages all Portfolio Development (CD/BM/CO) owned SOP updates in collaboration with critical partner SMEs where appropriate and ensures they are updated to reflect current processes and structure
• Drives the development of a fit for purpose technical training curriculum across PD that supports achieving quality program goals and standards.
• Provides guidance on process/procedural expectations and stakeholder management.
• Driving excellence through change management and objectives oversight in partnership with PD Chief of Staff
• Tracks and manages all Portfolio Development sponsored process development / improvement initiatives, in collaboration with the appropriate delegates and surface to PD CoS
• Identifies and drives cross functional initiatives to bring in technology
• May sponsor or lead cross-functional initiatives supporting design and execution excellence
• Tracks and manages all procedural documents update requirements to ensure compliance across the department in collaboration with the Portfolio Development Leadership Team and appropriate delegates.
• Provides innovative solutions to increase the excellence of Portfolio Development; aiming to reduce complexity, increase quality and speed, and reduce decision making churn.
• Represents Portfolio Development for applicable cross-functional R&D initiatives and forums.
• Core reviewer on all Portfolio Development SOP updates to ensure changes work systematically across procedural documents.

QUALIFICATIONS

• Bachelor's degree or equivalent in life sciences, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred.
• Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist).
• 12+ years experience in the biotechnology or pharmaceutical industry (or biomedical research organization)
• In-depth knowledge of drug development and GCP environment
• 5+ years experience in managing projects in Clinical Research and Development, first-hand experience in the execution of clinical trials is required
• 3+ years experience in managing process improvement initiatives, and influencing change in an organization
• Proven experience in leading cross‑functional, multicultural and international (product development) teams

The expected base salary range for this position at hiring is $230,000- $270,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed for Waltham MA at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.