Pranav Patel

• Provide strategic Therapeutic Area & program level contributions such as input to development plans and program-level strategies for Study Management. Ensure delivery of a portfolio of assets or compounds. • Provide managerial oversight to study management colleagues. Responsible for talent development of colleagues, preparing Study Managers to deliver on studies. Ensure Study Managers are following Pfizer SOPs and provide leadership & oversight to the CROs. • Responsible for the oversight & delivery of complex / high priority assets with multiple indications / studies. Ensure that Study Managers are delivering according to agreed plans & proactively escalate risks and deviations to plans, and that any asset level strategies are appropriately implemented. • Define & leverage performance data, e.g. operational metrics, study plan variance and trend reports to drive the business & support the oversight & management of Study Managers & CROs. Interface with CRO managers to resolve issues and escalate resource concerns. • Act as a Subject Matter Expert on study management processes and facilitate the sharing of therapeutic/functional area expertise & best practices within their group & where applicable across the Study Management organization. • Interface as needed with senior stakeholders across organization including but not limited to Clinical Operations Heads, Clinical Group Leads, BU and RU leaders, DM Group Leads, Area/country Heads to ensure appropriate issue resolution/escalation and healthy stakeholder relationships. • Interface with the senior stakeholders & leadership within pCROs to ensure optimization of services & drive progress across their assigned assets or therapy area. • Accountable for building & ensuring therapy/functional area expertise and technical study management expertise for their group of direct reports through recruitment & talent development/management of staff and the development of training strategies to enhance study management.

• Provide leadership to Clinical Trial Operations project teams to ensure delivery of project milestones • Represent Clinical Trial Operations in senior level, cross-functional teams and committees • Along with the Sr. Director, establishes a strategic vision and long-range plan for the RCTO team • Work globally to determine the best utilization and the optimal organization of the Trial Operations infrastructure and staff • Provide RCTO staff with appropriate coaching, mentoring and development • Provide guidance in the preparation and follow-up of in-house and on-site quality audits, as well as, regulatory authority inspections • Serve as Subject Matter Expert in one or more areas. • Develop new or leads the improvement of existing department systems and processes • Lead the implementation of process improvements or of new process across RCTO • Develop or improve SOPs and training guides applicable to a global organization • Ensure proper training is implemented to demonstrate CFR, GCP/ICH compliance • Participate in the selection of vendors and Contract Research Organization (CRO) services as required Leadership & Functional Competencies. May be a point of escalation for CRO’s performance in site management Infrastructure Development and Maintenance • Collaborate cross-functionally to deliver on portfolio milestones and establish best practices • Build, engage and energize the team and set high performance expectations

• Represent Clinical Operations platform in Clinical Development Project Team and act as main interface with other platforms/units for the project and Clinical Operations functions such as Trial Operations, Medical Operations, Statistics, Medical Writing, Clinical Supplies, Local Clinical study units, Clinical Quality, Records Management, Clinical Finance, Clinical Legal, and Clinical Procurement. • Lead the multi-disciplinary cross-functional Clinical Operations project team & accountable for team performance to secure the project deliverables within defined timelines, quality & budget. • Transmits clear project requirements to the Clinical Operations functions. Assesses the impact of the project on the platform. In conjunction with the function leads within the Clinical Operations, builds study teams that are adapted to meet project’s needs. • Develops and negotiates program budgets, timelines and other expectations in order to establish clear expectations. Accountable for financial oversight of the project/program. • Sets team goals and provides performance reviews for the team. • Anticipate project risks and develops and implements a risk management plan to minimize negative impact in fulfilling project deliverables. • Lead Clinical Operational Project Team meetings to address status & critical issues. • Builds a strong relationship with the project team, platform team and key stakeholders. Ensures appropriate communications channels are maintained and reporting schedules adhered to. • Responsible for routine reporting of the project’s status to the team & platform. Supervise maintenance of the project management information and tracking. • Identify opportunities for improving organizational processes & drive organizational excellence • Leads the discussion on the choice of vendors for outsourced programs, provides input into vendors used for specific activities and is accountable for deliverables of full-package outsourcing.

• Oversee activities of Trial Operations pre-approval inspection teams, ensuring team members are provided with appropriate coaching and training related to inspection readiness understanding and regulatory requirements (in collaboration with regulatory and Q&CI as needed) for Trial Operations CTOM team. • Ensure and monitor consistent implementation of standards and quality processes as they pertain to CTT best practices, PAI readiness, and ICH/GCP compliance within Trial Operations. Help to build a consistent “inspection ready mindset.” • Drive change and implementation of new approaches and standards within Trial Operations. Participate in working group for process improvements and development of global SOPs, guidelines or related tools in collaboration with Q&CI.

- Acted as trial operations DPE (Dedicated Project Expert) on a phase III program, Led & provided oversight on phase III studies operation from start-up to product submission for approval, including pre-approval inspection activities - Responsible for the overall operational planning and activities for the implementation and conduct of studies in compliance with GCP's, SOPs and standards within established timelines and budgets. - Provide oversight / coordination of global study operations to ensure progress according to planned study timelines. - Manage Trial start up activities; enrollment / Retention targets and related challenges; Database Lock activities - Develop and follow-up the study budget - Lead the study vendor selection, set-up & management. - Organize and lead cross-functional corporate CTT meetings; meetings with regional trial managers - Operational review of key study documents such as Protocol, WSI, CRF, CRF completion guidelines, Vendor specs & manuals, DMP, DVP, DRSP etc…. - Prepare Monitoring Plan, Risk management plan and other Operational Plans - Organize & participate in Monitoring team training and provide oversight on plans for investigator meeting - Coordinate and support field-monitoring & enrollment activities by developing global recruitment/retention plan and related tools. - Collaborate with the CSP to validate study IP needs, specifications, packaging, shipment (including resupply) and reconciliation process. - Ensure study documentation is properly maintained and archived in the Trial Master File (TMF) and relevant E-repository and databases as required. - Preparation and oversight of study audits/inspections both internal and external - Provide oversight and preparation for FDA pre-approval inspections (PAI) - Manage clinical trial management systems (such as IMPACT, ClubNet etc...)