Risk Management Lead

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

Purpose

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

Disability Inclusion

Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!

Quality Assurance and Control