Oncology Risk Management Lead

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

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.\nRelocation support available\n
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.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Quality Assurance and Control