Pritesh V. Shah Email & Phone Number

Edison, New Jersey, Us

As a President and the Founder of Lead the Genius, I work alongside CEOs, executives, HR, IT, Business, and Program Leaders to provide executive and leadership coaching. I help leaders to embrace uncertainties with courage using the B.R.A.V.E. mindset. I partner with leaders to elevate their competence, confidence, credibility, composure, communication, and connections. After partnering with me, leaders gain clarity about their current state, enhance their self-awareness, and optimize their untapped potential. They improved their balance, resilience, adaptability, versatility, and engagement mindset and demonstrated thriving and inspiring behaviors. Additionally, Clients confidently navigate uncertainty, effectively adapted to change, and delivered exceptional results. As an Executive and Leadership Coach and a Consultant, I help my clients with: • Executive and Leadership Coaching (1:1 and teams)• Hogan (HPI/HDS/MVPI) Personality Assessment • Leadership Assessments: Emotional (EI), Adaptability (AQai), and Positive Intelligence (PQ)• Imposter Syndrome (IS), Emotional Intelligence (EI), Adaptability workshops and training • IT, Program, Risk Management Consulting, and Facilitation Connect with me for a discovery call at 📞: https://calendly.com/leadthegenius/discovery

Jacksonville, Florida, Us

As an Executive and Leadership Coach, I help my clients with: • Executive and Leadership Coaching (1:1 and teams)• Hogan (HPI/HDS/MVPI) Personality Assessment • Leadership Assessments: Emotional (EI), Adaptability (AQai), and Positive Intelligence (PQ)• Emotional Intelligence (EI) workshops and training • IT, Program, Risk Management Consulting, and Facilitation

Berlin, De

I work alongside CEOs, executives, HR, IT, Business, and Program Leaders to provide executive and leadership coaching.As an Executive and Leadership Coach and a Consultant, I help my clients with: • Executive and Leadership Coaching (1:1 and teams)• Hogan (HPI/HDS/MVPI) Personality Assessment • Leadership Assessments: Emotional (EI), Adaptability (AQai), and Positive Intelligence (PQ)• Emotional Intelligence (EI) workshops and training • IT, Program, Risk Management Consulting, and Facilitation

New York, New York, Us

As an Executive and Leadership Coach, I help my clients with: • Executive and Leadership Coaching (1:1 and teams)• Hogan (HPI/HDS/MVPI) Personality Assessment • Leadership Assessments: Emotional (EI), Adaptability (AQai), and Positive Intelligence (PQ)• Emotional Intelligence (EI) workshops and training • IT, Program, Risk Management Consulting, and Facilitation

Austin, Texas, Us

As an Executive and Leadership Coach, I help my clients with a Whole Person Mindset (WPM) to help them thrive, inspire, and deliver exceptional outcomes: • Executive and Leadership Coaching (1:1 and teams)• Hogan (HPI/HDS/MVPI) Personality Assessment • Leadership Assessments: Emotional (EI), Adaptability (AQai), and Positive Intelligence (PQ)• Emotional Intelligence (EI) workshops and training • IT, Program, Risk Management Consulting, and Facilitation

London, Uk, Gb

As a Foundation Certified Practitioner with AQai, I am committed to their mission: to inspire & empower every human with the skills to adapt and thrive. Ensuring no one is left behind in the fastest period of change in history. Transforming the way employees, teams and organizations thrive in change. AQai is a pioneer in organizational adaptability to support the development of highly adaptable employees, safeguarding careers, unleashing potential, and protecting the future of their organizations. Adaptability and resilience are rated the No.1 most important skill by L&D professionals according to the 2021 Linkedin Workplace Survey. We highlight one of the most pressing problems in supporting people through change, transformation, disruption, and re-skilling. Together, we empower people, teams, and organizations to assess, understand, and change the behaviors needed to adapt to our ever-changing environments successfully. Let’s talk about how we can develop highly adaptable employees to help them safeguard careers, unleash potential, and protect the future of their organizations. Lack of adaptability costs businesses $19.8b per year in HR, according to PWC. Protect your organization from disruption. Upgrade your organization’s adaptability performance with detailed metrics, benchmarking, and coaching support.

London, Gb

Recognized for delivering mission-critical transformations, optimizing PMO, Program delivery, Change adoption, and Quality and Compliance. Accelerated growth and innovation, improved operational excellence, and delivered results for fortune 500 clients. Served as a trusted advisor for C-suite: Demonstrated experience in leading the program's planning, execution, and risk remediation for complex initiatives.• Managed Merger and Integration / Divestitures: Delivered TSA Objectives for the $5.5M Medical Devices Integration. Optimized Integration Management Office (IMO), defined integration strategy, portfolio roadmap, processes, and execution plans. Led global teams, monitored the performance of PMs and vendors. Integrated 75+ R&D and IT applications, migrated data and managed quality, privacy, and compliance. For R&D, Documentation and storage, and IT Enablement capabilities (i.e., Veeva, JIRA, Confluence, Solid works, etc.). • Managed Integration for Four Biotech Organizations: Integrated clinical and regulatory assets for four biotech acquisitions. Evaluated technology integration strategy, organization, business applications, infrastructure, and controls. Aligned stakeholders and vendors, minimized quality and compliance risks, and ensured the SDLC and regulatory compliance. Drove change adoption for the IT assets integration. • Managed Divestiture and creation of Independent organization: Conducted Independent Program assessments for the Divestiture of ERP and IT application suite of applications. The assessment scope was to ascertain the Divestiture roadmap, program controls, Validation approach, and Go-live and Change readiness. Provided status and progress updates and recommendations to C-Suite leaders on program performance. Established Project management, software development, product life cycle (PLM) management, and validation approaches. Delivered business process and performance improvement and quality and regulatory compliance programs

London, Gb

Advised clients in IT, Financial Services, pharmaceutical, Life Sciences, Healthcare, Medical Devices, and Government industries. Optimized program management office and program governance, project planning, execution, and risk management for complex programs• Optimize Program Management Office Performance: Develop a baseline understanding of the program’s maturity and risks (Inherent and known) for multiple clients. Investigated root causes for poor program performance. Established PMO operating model, aligned business and IT strategy, program’s vision, execution, risks, quality, audit, change implementation strategies, decision-frameworks, and IT and program execution capabilities.• Execute Complex Programs: Created / Refined Program execution methodology, Program Audit methodology, program plans, integration (Risk, Issues, communication, quality, Change, and vendor management), and approaches. Evaluated performance reporting (Accuracy and completeness), Vendor and Quality risks, and vendor performance management needs. Customized program governance, performance reporting, and communication capabilities. Enhanced performance visibility and transparency to minimize the intent and execution risks. • Remediate and Recover Complex Programs: For multiple clients, assessed transformation program’s complexity and maturity, identified program, IT, Vendor, quality, and compliance risks across project management, program governance, and solution delivery areas. Developed troubled program remediation plans and provided oversight for recovery program implementation and benefit realization.

• Improved performance predictability, transparency, and realized integration objectives for Merck and Schering-Plough's merger. Aligned cross-company teams, customized governance, decision, RACI, dependency frameworks, and KPIs. Monitored execution of program performance management plans• Aligned Operations: Streamline IT Operations, crafted and aligned IT services strategy, defined service processes, and frameworks, transitioned service processes, and re-trained resources. Built insight into the cost of quality, resource utilization, and root causes of Incidents and problems, and improved customer satisfaction by 90%. Integrated additional suppliers to align IT services and technical operations and transformed IT quality and compliance processes resulting in a 50% reduction in operational costs. • Managed Vendor Relationships and performance: Implemented a Service improvement framework, defined service strategy and operating model, identified service requirements, evaluated RFPs, negotiated and consolidated five service desks. Established IT governance, optimized IT and Vendor performance and relationships. Monitored SLA performance and transformed outsourced service providers into a strategic partner. • Maintained Process, Quality, and Compliance: Held PDAM Portfolio in a validated state. Ensured compliance with Regulatory and Corporate policies. Established, maintained, and adhered to MRL Quality and Compliance, verified that Portfolio is inspection ready and, as required implemented CAPAs to enhance compliance. Designed, developed, and implemented Corrective and Preventative Actions (CAPA) to address remediation and prevention needs.

• Assessed Business needs and IT capabilities: Led Patient Data Acquisition Management (PDAM) business and technology teams to support end-to-end Clinical Trial Operations, including Safety and Pharmacovigilance. Aligned stakeholders, identified business capabilities, defined business requirements, and assessed new product/technology fit. Conducted user requirements workshops and influenced Vendor Product strategy, capabilities, roadmaps, and release schedules. • Delivered R&D IT Capabilities: Led complex global R&D transformation programs and acquired platform technologies. Minimized project management, program governance, and solution delivery risks. Customized program plans, execution, change implementation, and training strategies for operational capability and process transformations. Provided oversight for program performance, cost, schedule, testing and validation, quality and business acceptance, and operational roll-out. • Managed Change Adoption: Accelerated the change adoption for the roll-out of changes for a global portfolio. Aligned capability, business process, validation, quality, compliance, release documentation and deployment, communication, go-live readiness, and training needs, and created change adoption plans: Led validation, implementation, and training and change deployment strategies. Integrated stakeholders, vendors, DR/BCP, and training delivery.

Created IT Analytics Infrastructure: Gathered business requirements, identified end-to-end process KPIs, and designed IT solutions (Trial / Therapeutic Area and Portfolio level) to measure Patient Data Acquisition Management process performance. Improved performance transparency, Cycle time cost of quality, and reduced waste by 30% for Clinical trial operations. Implemented Process Performance Management Framework: Prioritized Clinical Data Management (CDM) IT Capabilities Project Portfolio. Defined PDAM Performance Management (PPM), a continuous process improvement framework, IT solution, operating model, and reporting cadence. Delivered training to entire Clinical Data Management and supporting vendors to identify process design and improvement opportunities. Reported Performance to Balanced Scorecard: Designed, developed, and implemented global analytics and business performance improvement solutions. Aligned IT, Business, and Vendor Governance. Established Business Intelligence (BI), Data and Governance frameworks, and performance review cadence. Streamlined reporting of process performance to Balance Scorecard KPIs and KRIs

Iselin, New Jersey, Us

•Directed and supervised the performance of global contract staff. Managed Therapeutic Area (TA) programs (Vioxx, Arcoxia, Zocor, Fosamax, Singular, etc.) and supported 10000 users in 35 countries. Provided oversight of global study teams and resolved data collection, query, mapping, data-flow, SAE Reporting, quality, and integrity issues. Delivered Data entry and review, site onboarding and monitoring, and SAE reporting training to functional and study teams. •Completed > 45 critical Database Locks (DL) by uniting and directing culturally diverse global teams to transmit quality clinical data on-time. Supervised and directed Consultants to support global Database Locks (DL) by providing production support, managing trial data integrity, ensuring timely and accurate data corrections, performing database locks, critical changes, and establishing Integrated Summary of Safety (ISOS) frameworks to support New Drug Application (NDA) Filings. •Managed development of e-CRF, data collectors, database views, queries, data entry, and handling guidelines and Integrated vendor data to Merck’s clinical trial database. For eleven TAs, led development and delivery of study startup, conduct, and closeout deliverables for Phase I-V clinical trials. Delivered database locks, CSRs, ISOS, and SURs for FDA submissions. •Enhanced operational excellence. Built insight into the cost of quality, resource utilization, and root causes. Minimized database cycle time to 10 days, reduced critical data changes by 85%, and saved $1M per trial.

Master Of Business Administration (M.B.A.), Technology Management

Master'S Degree (Ms), Technology Management

Masters In Project Management, Project Management

Masters, International Finance

Bachelors, Mechanical Engineering

High School Graduate

Certified Career And Executive Coach, Executive And Leadership Coaching