Pfizer
Oncology Risk Management Lead
Job Function:
Job Type:
Location:
United Kingdom - Cambridge
Based:
Closing date:
ABOUT THE ROLE
JOB SUMMARY:
The Oncology Quality Risk Management Lead (RML) is a strategic role in the Oncology Quality value chain for driving holistic risk management practices across clinical development. The RML is an expert in Oncology quality risk management that drives risk identification and management from an end-to-end global clinical trials perspective that encompasses GCP, GVP, and GLP environments. The Oncology Quality RML partners with the appropriate functional lines, and quality groups to drive Oncology quality 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 Oncology Quality RML provides expertise to help identify and mitigate risk across the enterprise. The Oncology Quality 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.
JOB RESPONSIBILITIES:
Risk Management Excellence
Owning, influencing, and innovating Oncology quality elements of the Pfizer R&D (PRD) Risk Management Framework, risk scoring methodology, risk universe, and quality governance structure
Maintaining a standardized risk library and the risk management system(s)
Drive consistent development of risk plans across domains in the Oncology portfolio
Experience with building requirements for, and utilizing improved risk and predictive analytics/dashboards to help identify and manage risk, and to prevent the occurrence of repeat issues; monitor risk management effectiveness over time
Collaborate with stakeholders across risk domains in identification, analysis, control, mitigation, communication, and closure of risks
Implement tools, technologies, and training to support the adoption and adherence to the risk management framework
Risk Mitigation
Providing strategic quality direction to Pfizer Oncology Division (POD) teams for quality risk mitigation and issue remediation
Domain Risk Visibility and Reporting
Coordinating risk escalation to governance committees and acting as a risk liaison to support risk owners
Fostering transparency by creating communication strategies to inform leadership and stakeholders about risks
REQUIREMENTS
QUALIFICATIONS/SKILLS
Experience in Quality Risk Management systems, tools (e.g., FMEA, risk register, risk matrix, etc.), processes, and concepts and business impacts of the process
Experience with implementing, and managing quality governance forums
Maintain visibility into enterprise-wide quality risks and signaling/flagging from various dashboards, and using this visibility to escalate risks to leadership
Must have a solid understanding of Good Clinical Practices (GCP), and ICH Q9, and an extensive background in clinical drug development. Additionally, a strong understanding of GvP and/or GLP is preferred.
Ability to understand large complex processes with a focus on quality, control and continuous improvement
Critical thinker able to utilize qualitative and quantitative data to inform risk-based decisions
Proven track record of leadership and influence
Advanced knowledge, experience and expertise in clinical trials / development, and operational quality management disciplines
Ability to engage with agencies and forums external to Pfizer to gather insights and information relevant to risk management
Strong, demonstratable analytic and data storytelling capabilities
A scientific or technical degree is preferred. In general, candidates for this job would have the following levels of experience:Bachelors – 14 years or equivalent
MS/MBA – 12 years or equivalent
PhD/PharmD/MD – 9 years or equivalent
ORGANIZATIONAL RELATIONSHIPS
Partners with the leads in PRD and POD functional lines and quality groups to drive effect risk management
Partners with Business Process Owners on aspects of process risk that impacts the Division
Partners with Regulatory Quality Assurance (RQA) on management of risks resulting from audits and inspections
Partners with Analytics teams on creation, maintenance, and/or use of tools and dashboards
Partners with IM/Digital Technology roles on risk management for innovation projects
Partners with Global Privacy Office related to data privacy risks and controls
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Relocation support available
Work Location Assignment: Hybrid
The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
ABOUT THE COMPANY
Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.
HOW TO APPLY
