CSL Limited

Director, Portfolio Development Process & Standards Lead

CSL Limited$250K — $280K *
Pharmaceuticals & Biotech
11 - 15 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in life sciences, nursing, pharmacy, or related area preferred.
  • 12+ years in the biotechnology or pharmaceutical industry.
  • In-depth knowledge of drug development and Good Clinical Practices (GCP).
  • 5+ years in managing projects in Clinical Research and Development and execution of clinical trials.
  • 3+ years managing process improvement initiatives and influencing organizational change.
  • Proven experience leading cross-functional and international teams.

Responsibilities

  • Establish and maintain a framework for Global Portfolio Development in clinical trials.
  • Manage updates to Portfolio Development SOPs in collaboration with key stakeholders.
  • Develop a technical training curriculum to support quality program goals and standards.
  • Track and manage process improvement initiatives within Portfolio Development.
  • Drive cross-functional initiatives to enhance design and execution excellence.
  • Ensure compliance across all procedural documents with relevant team members.
  • Provide innovative solutions to simplify processes and increase quality and speed.

Benefits

  • Hybrid work model with three days onsite.
  • Opportunities for continued training and professional development.
  • Participation in cross-functional initiatives and projects.
  • Collaborative work environment with diverse teams.
  • Role is instrumental in shaping the quality and standards of clinical trials.
Full Job Description
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 $250,000 - $280,000. 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.

About CSL Limited

CSL Limited is a global biotechnology company that develops and delivers innovative biotherapies and influenza vaccines to protect public health. They have a focus on rare and serious diseases, and their products are used in more than 70 countries. CSL Limited was founded in 1916 in Australia, and has since grown to become one of the largest biotech companies in the world. They have a strong commitment to research and development, and invest heavily in new technologies and therapies. CSL Limited is listed on the Australian Securities Exchange and the NASDAQ, and has a market capitalization of over $100 billion.
Learn more about CSL Limited
Size
25,000 employees
Industry
Founded
1904
NASDAQ

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