Director, Portfolio Development Process & Standards Lead

CSL Plasma•Waltham, MA

8d•Hybrid

About The Position

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.

Requirements

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

Responsibilities

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.