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For Companies At a Glance
- Tasks: Lead risk management for clinical trials, ensuring patient safety and regulatory compliance.
- Company: Join Pfizer, a global leader in pharmaceuticals dedicated to improving healthcare outcomes.
- Benefits: Enjoy hybrid work options, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on patient safety while working in a dynamic, innovative environment.
- Qualifications: BA/BS with 10+ years experience or MBA/MS with 9+ years in clinical drug development.
- Other info: Apply with your CV and motivational letter in English.
The predicted salary is between 54000 - 84000 £ per year.
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
- Providing strategic quality direction to functional line leads for quality risk mitigation and issue remediation
- 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.
Risk Management Lead employer: Pfizer
Contact Detail:
Pfizer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Risk Management Lead
✨Tip Number 1
Familiarise yourself with Good Clinical Practices (GCP) and the latest trends in clinical drug development. This knowledge will not only help you understand the role better but also allow you to engage in meaningful conversations during interviews.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in risk management. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest challenges and solutions in the field.
✨Tip Number 3
Prepare to discuss your experience in leading cross-functional teams and implementing successful processes. Be ready to provide specific examples of how you've managed risks in previous roles, as this will demonstrate your expertise and suitability for the position.
✨Tip Number 4
Stay updated on regulatory changes and data privacy requirements that could impact clinical trials. Showing that you are proactive about understanding these areas will highlight your commitment to patient safety and compliance, which is crucial for this role.
We think you need these skills to ace Risk Management Lead
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Risk Management Lead position. Familiarise yourself with Good Clinical Practices (GCP) and the specific skills mentioned in the job description.
Tailor Your CV: Customise your CV to highlight relevant experience in risk management, clinical drug development, and any leadership roles you've held. Use keywords from the job description to ensure your CV aligns with what the company is looking for.
Craft a Compelling Motivational Letter: In your motivational letter, express your passion for quality risk management and how your background makes you a perfect fit for the role. Be sure to mention specific experiences that demonstrate your analytical and problem-solving skills.
Proofread and Edit: Before submitting your application, carefully proofread both your CV and motivational letter. Check for any grammatical errors or typos, and ensure that your documents are clear and professional.
How to prepare for a job interview at Pfizer
✨Showcase Your GCP Knowledge
Make sure to brush up on Good Clinical Practices (GCP) and be ready to discuss your understanding of them. Highlight any relevant experience you have in clinical drug development, as this will demonstrate your expertise in the field.
✨Prepare for Analytical Questions
Expect questions that assess your analytical skills and ability to identify risks. Be prepared to share examples of how you've used data-driven approaches and predictive analytics in previous roles to mitigate risks effectively.
✨Demonstrate Leadership Experience
Since the role involves influencing senior leaders and leading cross-functional teams, come equipped with examples of your leadership experience. Discuss how you've successfully managed teams and driven strategic discussions in past positions.
✨Foster a Culture of Innovation
Be ready to talk about how you've promoted innovation in your previous roles. Share specific instances where you've implemented new processes or policies that improved patient outcomes or enhanced operational quality.
