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As part of the Clinical Data Sciences (CDS) group, an integral delivery unit within the Clinical Development & Operations (CD&O) organization, the Head CDS Argentina is a key leader and influencer across Global Pfizer R&D on behalf of the CDS functions and the geography they represent. CDS is a critical partner in the advancement of Pfizer’s development pipeline and this role is a key component of cross-functional R&D planning at the function, TA and program level. As such, the goals of the individual in this role will be aligned with the Global CDS Head, the CDS Roadmap and R&D priorities. They are accountable for all CDS activities, deliverables, and resources in their geography within CDS from planning through submissions, including all clinical trial data and analyses generated from their department being fit for purpose and aligned with the relevant development plan(s). Their span of control includes multiple CDS sub-functions (Reporting, RBM, DB Build, etc.), multiple TA’s, multiple indication groups, including priority programs and multiple functions within CDS.
Job Responsibility:
Within CDS, lead a regional team comprised of multiple specialized functions and the local resources supporting and/or leading global trials across multiple TAs
Lead and influence across R&D on behalf of their TA Group or Function as a key component of cross-functional R&D planning
Build a brand-new and/or foster CDS departmental presence that has a strong local culture while being a fully integrated member of the worldwide CDS organization
Develop a departmental roadmap starting with the departmental vision, defined through targeted outcomes, strategic initiatives, and tactical deliverables
Ensure strong partnerships within global CDS, across R&D through collaborations with senior leaders (SVP, VP, ED and SD), senior level stakeholders and with external vendors
Act as a thought leader with the network to drive innovation within the organization and across the industry. Lead the conversation in key industry forums through presentations and publications
Lead clinical and non-clinical cross-functional special projects aimed to evolve CDS and partner functions in line with the Pfizer organization and the changing industry landscape
Set current and future strategy as a core member of the CDS Leadership Team
Span of control of 50 or more people or equivalent in terms of functional areas of accountability
As requested, deputize for the responsibilities of the Global Head of CDS
Shared accountability along with peer LT members for overall CDS budget and planning and specific accountability for CDS deliverables. Align delivery strategy to ensure responsible, efficient use of resources to deliver analyses required within budget
Accountable for accurate forecasting for future budget estimates and direct reports expenses. Develop budgets and resourcing plans for Geography. Determine headcount needs in conjunction with development pipeline
Manage an organization of 50 or more employees and third-party staff
Direct reports at levels of Associate, Senior Associate, Manager, Senior Manager up to Director as appropriate
Oversee vendors (CROs and partners) performing data processing, data management and study start-up, study conduct, and study close out activities
Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy
Requirements:
University or college degree in life science, computer science, pharmacy, nursing, or equivalent relevant degree. Advanced degree preferred
Ideally 20 or more years’ experience in drug development with at least 10 years in Clinical Data Management
At least 10 years' line management or global project team leadership experience
Clinical development and business experience in order to have a thorough understanding of regulatory processes at a global level
Recognition in peer community as expert and leader in topic area
Ability to leverage network to establish/maintain contact with scientific community
Exceptional technical and problem solving skills, and ability to evaluate computer systems for Data Management
Excellent understanding of clinical trials methodology, GCP and medical terminology
Experience of interaction with major regulatory authorities (not only in India)
Ability to work under pressure, demonstrating a high level of initiative and flexibility
Demonstrate effective and innovative leadership, with substantive experience building and leading a team
Excellent organizational, planning, resource, and global project management skills
Advanced interpersonal and communication skills and ability to manage effectively in an international organization
Executive capability to mentor and coach associates
Superior people management skills with demonstrated positive leadership, innovative and collaborative behaviors
Ability to work effectively in a multi-cultural context and knowledge of team development principles
Ability to provide leadership and management oversight, with particular emphasis on the ability to lead process development and improvement initiatives
Proven ability to manage the performance of others to meet business objectives as well as colleague development objectives
Knowledge of Windows Environment and its applications (Word, Excel, PowerPoint, Project, etc.)
Project management skills that can be used to facilitate efficient resource allocation and ensure adherence to timelines
Excellent verbal and written communication skills in relating to stakeholders and colleagues
Demonstrated ability to create clear written professional communications
Excellent knowledge of drug development and knowledge of methodology of clinical study and drug development