Director, Clinical Risk Management – Post Approval Delivery Unit

Role Overview

• Oversees the overall risk management of a Disease Area Stronghold (DAS) or development phase.
• Works with CRM Representatives to ensure the coordination of, identification, assessment, and mitigation of quality risks.
• Provides oversight to the execution of data-driven, risk-based trial and program oversight activities.
• Establishes goals and objectives for CRM Representatives.
• Performs mid-year and end-of-year review for CRM Representatives.
• Coordinates upskilling knowledge workshop series for CRM Representative team development.
• Drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.
• Develops and ensures a consistent interpretation of issues that require quality investigations.
• Supports and leads the coordination of the quality integration of the acquiring asset or company/partner.

Requirements

• A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
• A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) is required.
• Proven strong GCP Quality and/or clinical trials experience is required.
• Excellent interpersonal, oral, and written communication skills to effectively collaborate in a cross-functional team environment is required.
• Flexibility to respond to changing business needs is required.
• Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
• Proficiency in Microsoft Office Applications is required.
• Experience with fundamentals of clinical trial risk management is preferred.
• Experience working to ICH guidelines is preferred.
• Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and/or Good Pharmacovigilance Practice (GPvP) is preferred.
• Health Authority Inspection experience (FDA, EMA, and other inspectorates) is preferred.
• Strong Project Planning/Management skills is preferred.
• Experience in managing escalations and CAPA support/advisement is preferred.
• Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related) to analyze/interpret collective data and provide insights to drive decision-making is preferred.
• Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease) is preferred.
• Requires proficiency in speaking and writing English.
• Up to 10% of travel, primarily domestic with some international travel.

Tech Stack

• Google Cloud Platform
• Tableau

Benefits

• Inclusive work environment
• Career development opportunities