Risk Management Lead

Pfizer; Stone Cross; Hybrid; GBP 100,000 - 125,000

Job description

Use Your Power for Purpose

The GCP Risk Management Lead (GRML) is a strategic role in the GCP Quality (GCPQ) value chain for driving holistic quality across clinical development. The RML is an expert in GCP quality risk management that drives the holistic risk identification and management from an end-to-end global clinical trials perspective. The RML partners with the appropriate functional area leadership and quality leadership to drive GCP risk management to proactively prevent negative impacts to patient safety and well-being, reliability of trial results, and regulatory compliance. Utilizing data driven approaches and predictive analytics, the RML provides GCP and risk expertise to identify and mitigate risk in the following domain areas: submissions, asset and study, 3rd party, innovative partnerships/initiatives and the external environment. The RML drives strategic discussions and influences senior leaders in the functional lines and quality groups to develop effective risk mitigation strategies to reduce any significant negative consequences to patients, colleagues and Pfizer’s reputation.

What You Will Achieve

In this role, you will:

• Risk Management Excellence
• Owning Risk Management Framework, risk scoring methodology, and risk universe
• Maintaining a standardized risk library and the risk management system(s)
• Flagging risk patterns across the study lifecycle
• Leverage quality measures to identify issues/trends and to bring to attention of appropriate functions/teams across domains (enterprise, process, third party, data privacy, site organization, site, study, asset)
• Developing and utilizing improved risk and predictive analytics to identify and manage risk and to prevent the occurrence of repeat issues; monitor risk management effectiveness over time
• Oversight via review of metrics on a set cadence
• Risk Mitigation
• Providing strategic quality direction to functional line leads for quality risk mitigation and issue remediation
• Domain Risk Visibility and Reporting

Identify and manage risks in: third parties, clinical trial operational quality, innovative partners and initiatives, regulatory intelligence, data privacy, industry sensing, and market insights to mitigate negative impacts in the GCP area related to patient safety and well-being, reliability of trial results, and regulatory compliance.

Here Is What You Need (Minimum Requirements)

• BA/BS with at least 10 years of experience or MBA/MS with at least 9 years of experience
• Solid understanding of Good Clinical Practices (GCP) and an extensive background in clinical drug development. Strong analytical, organizational, communication, and people skills
• Experience in implementing successful processes and policies
• Ability to work independently in a highly matrixed organization
• Proven track record of leading high-performing cross-functional teams
• Expertise in quality risk management and compliance
• Experience in developing strategies for a portfolio of products and projects

Bonus Points If You Have (Preferred Requirements)

• A Master's degree is highly desirable, coupled with relevant experience in the pharmaceutical industry
• Demonstrated ability to foster a culture that promotes innovation and thrives on improving patient and healthcare outcomes
• Excellent problem-solving skills with a focus on innovative solutions
• Ability to build and leverage constructive relationships across the organization
• Experience in providing quality systems' implementation guidance across business units
• Experience related to one or more of the risk domains areas would be beneficial
• Vendor Management: Integrated, inclusive vendor-level risk management
• Clinical Trial Operational Quality: Cross-functional, end-to-end quality risk management
• Innovative Partnerships/Initiatives: Nuanced risk management for novel partnerships and initiatives
• Regulatory Intelligence: Comprehensive view of regulatory changes, trends, and potential impacts
• Data Privacy: landscape of data privacy requirements across countries and US states
• Industry Sensing: Industry risk management (i.e., best practices, benchmarks, emerging risks)
• Market insights: Country/regional dynamics with risk management implications
• Ability to act as an advisor and expert within the organization

Work Location Assignment: Hybrid

Please apply by sending your CV and a motivational letter in English.