The Clinical Operations Head Oncology (COH) is the leader of a best in class clinical operations group with accountability for the operational delivery of all global clinical studies within the Oncology category from first in patients through to loss of exclusivity, and a member of the CD&O Leadership Team. They will act as the key Clinical Development and Operations (CD&O) strategic partner to the Chief Development and Chief Scientific Officers within the category ensuring that the respective portfolio is appropriately prioritized, resourced and delivered according to agreed strategy, timelines and budget. The COH will lead a group of up to 50 clinical operations leaders and colleagues distributed across Pfizer sites and virtual / global locations.
The COH is held directly accountable by the head of CD&O for the operational delivery of the portfolio of studies within a therapeutic category. The oncology portfolio of work approximates to between 5,000 to 12,000 active patients at up to 2000 Pfizer Clinical Development sites across the world.
The COH will inform, influence and drive decisions in a given therapeutic category through the application of quantitative, data driven operational planning and execution and by active participation at, and leadership of, major governance meetings.
In partnership and close collaboration with other COH's and functional lines within CD&O s/he will be responsible for leading the identification, development and implementation of clinical operations standards, processes and industry leading best practices. The COH will be held accountable for the thoughtful adoption and utilization of digital and innovation within their portfolio.
The COH will set the highest expectations for quality and operational excellence, fostering a culture of continuous improvement and inspiring Clinical Study Team Leads (CSTL) to lead with purpose and deliver against Pfizer's strategic imperatives. S/he will actively engage in talent development and provide the structural and cultural framework for the development of team leaders, realizing the potential and maximizing the impact of the CSTL role.
S/He safeguards the safety and wellbeing of trial participants through the provision of high-quality operational oversight and is a
point of escalation for operational quality issues arising from sites and the development of associated CAPAs.
Serves as the as the single point of accountability for the operational delivery of a portfolio of clinical studies and regulatory submissions consistent with the requirements of the clinical development plan.
Identifies, leads and implements industry leading best practices for the conduct of clinical trials within their therapeutic category.
Drives a culture of continuous improvement and a workforce that excels in clinical project management execution
Sets expectation, secures resources and holds CSTLs accountable for the delivery of clinical studies to the highest quality standards, against agreed timelines and within assigned budget.
Accountable to ensure CSTLs are effectively leading study teams through various stage gates, ie. FIH, FIP, POC, PSS, DP3 and Quality Gates etc as well as overseeing the quality and accuracy of data input for management reporting on study performance.
Ensures risk management and risk mitigation strategies are in place and implemented for all studies in respective portfolio.
Ensures Therapeutic Area deliverables align with Pfizer/industry leading standards on quality, speed and cost for clinical plan operationalization
Holds CSTLs accountable for ensuring study teams are inspection ready at all times.
Influences and informs clinical development strategy, portfolio prioritization and budget allocation through clinical operations input to therapeutic categories.
Inspires, motivates and engages operations colleagues, providing clarity of purpose and sets expectations of operational excellence, and continuous improvement.
Develops talent management plan and provides infrastructure and support for continued professional development.
Collaborates within CD&O and across GPD to develop, prioritize and support leadership team activities.
Ensures compliance with all applicable regulatory, operational and technical requirements, including global and local training requirements and adherence to relevant global / local SOPs assigned to roles.
Bachelor's Degree required
Advanced degree or professional certification in a health care related, scientific or technical discipline preferred.
At least 15 years of experience and track record of success in biopharmaceutical industry in clinical research and development
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
Demonstrated experience managing and training large teams in clinical development
Demonstrated experience in designing and launching large teams preferred
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel required
Other Job Details:
Last Date to Apply for Job: October 16, 2020
Eligible for Relocation Package Yes
Eligible for Employee Referral Bonus Yes
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