Jennifer V.

Provided operational leadership for the Rocatinlimab global development program, one of Amgen's high-priority immunology assets, serving as the sole Clinical Program Manager during the program's foundational development phase and establishing the operational framework that supported subsequent program expansion. Key Contributions Led end-to-end operational strategy and execution for the program's first pivotal adult study, successfully achieving all major milestones including feasibility, regulatory submissions, study activation, First Patient In (FPI), enrollment targets, database lock, and final analysis. Directed global feasibility strategy in partnership with CRO leadership, independently overseeing country and site assessments, enrollment forecasting, operational risk evaluation, and site selection activities during the program's early development phase. Drove successful regulatory execution, including oversight of submissions to the European Clinical Trials Register (EUCTR), ensuring alignment with global activation timelines and development objectives. Established the operational foundation for a rapidly expanding global program, successfully transitioning from sole CPM oversight to a multi-CPM operating model while maintaining continuity, governance, and execution excellence. Spearheaded development and implementation of Amgen's Local Trial Manager (LTM) engagement strategy, helping define the role's operational integration within the organization. Participated in recruitment, onboarding, and mentoring of LTMs, contributing to capability development and establishment of a high-performing study management organization. Provided strategic oversight of patient recruitment and enrollment across seven global studies, partnering with CROs, site networks, and cross-functional stakeholders. Collaborated closely with Clinical Development, Regulatory Affairs, Data Management, Biostatistics, Medical Affairs, and external partners.

Led operational oversight and execution of a First-in-Human (FIH) oncology clinical trial, partnering closely with Clinical Development, Medical, Regulatory, and Program Management teams to support successful study delivery and advancement of early-stage assets. Provided strategic oversight for Phase I oncology studies, translating clinical development objectives into operational execution while ensuring protocol compliance, data quality, patient safety, and inspection readiness. Directed CRO oversight and governance activities, proactively identifying and mitigating operational risks, monitoring study performance, and ensuring adherence to timelines, budgets, and quality expectations. Authored Clinical Operations processes, study execution plans, and operational procedures to support organizational growth and standardization within a rapidly evolving biotechnology environment. Collaborated cross-functionally with Clinical Development, Regulatory Affairs, Data Management, and Program Management to support protocol execution, study start-up, and delivery of high-quality clinical data. Trained and mentored Clinical Operations personnel, establishing best practices and fostering a culture of operational excellence and accountability.

Key Contributions Spearheaded the expansion and implementation of an innovative home infusion framework across the DMD program, partnering closely with clinical sites, home healthcare providers, and specialized infusion vendors to maintain continuity of treatment during the COVID-19 public health emergency. Led cross-functional planning and execution efforts to rapidly design, operationalize, and scale home dosing processes, ensuring compliance with protocol requirements, patient safety standards, and regulatory expectations. Developed and executed patient-centric operational strategies that enabled uninterrupted access to study treatment despite widespread site closures, travel limitations, and healthcare system constraints. Collaborated with investigators, study coordinators, vendors, logistics partners, and internal stakeholders to identify and mitigate operational barriers, creating alternative treatment pathways that preserved study integrity and patient safety. Implemented innovative solutions to address travel restrictions and access challenges, ensuring that patients could continue participation in clinical trials without disruption. Successfully maintained treatment continuity across the program, achieving a 100% dosing adherence rate with no missed patient doses during the height of the pandemic. Served as a key operational leader during a period of significant uncertainty, providing proactive risk management, stakeholder alignment, and strategic decision-making to support successful trial execution. Established scalable operational practices and patient-focused delivery models that contributed to long-term adoption of decentralized and home-based clinical trial approaches.

Key Contribution Participated in 10 bid defenses and helped win 6 new programs, including a major sponsor engagement in Shanghai. Led a team of seven Project Managers during a period of organizational transformation, overseeing strategic resourcing, financial forecasting, operational performance, and client delivery across a global oncology portfolio. • Partnered with Business Development and Global Project Leadership teams to support proposal development, operational strategy, and executive-level bid defenses, contributing to the successful award of 6 new clinical development programs. • Represented Clinical Operations during global bid defense presentations, including a high-profile sponsor engagement in Shanghai, helping secure strategic business opportunities and strengthen the organization's global oncology portfolio. • Served as a trusted client-facing leader, translating complex operational strategies into executable delivery models that increased sponsor confidence and improved proposal competitiveness. • Led organizational change initiatives focused on modernizing clinical operations processes, implementing automation, standardization, and governance enhancements that improved operational efficiency and delivery consistency. • Directed execution of complex Phase I-III global oncology studies, ensuring achievement of key milestones, quality objectives, budget expectations, and client commitments. • Established standardized study start-up frameworks and performance metrics that reduced cycle times, improved operational predictability, and accelerated study activation. • Provided strategic oversight of resource planning and financial forecasting across multiple programs, ensuring efficient utilization of personnel and operational budgets. • Mentored and developed Project Managers, fostering a culture of accountability, collaboration, operational excellence, and leadership development.

Key Contribution Led the digital transformation of Clinical Operations at a growing CRO by selecting, implementing, and operationalizing core clinical development systems that became foundational to study execution and client delivery. Directed development and execution of global Clinical Development Plan across oncology programs, integrating strategic feasibility assessments, risk management, operational planning, and value-based decision making to support client development objectives and business growth. • Partnered with executive leadership, operational teams, and external clients to define program scope, development strategy, success metrics, and key performance indicators (KPIs) across multiple global clinical programs. • Led Clinical Operations efforts to implement and operationalize the organization's first Clinical Trial Management System (CTMS) and Veeva eTMF platform, establishing scalable infrastructure, standardized processes, and enhanced oversight capabilities across the clinical development portfolio. • Served as a key business and operational stakeholder throughout system implementation, driving requirements gathering, process design, workflow development, user adoption, training, and change management activities. • Contributed directly to Electronic Data Capture (EDC) system development and configuration, partnering with technical teams to design and build study-specific functionality that improved data collection processes and study execution efficiency. • Championed organizational process transformation initiatives that strengthened operational consistency, improved inspection readiness, increased data visibility, and enhanced cross-functional collaboration. • Implemented operational improvements that accelerated study start-up timelines, improved study governance, and increased predictability of clinical trial execution.

Provided global project leadership across multiple therapeutic areas within both Functional Service Provider (FSP) and Full-Service clinical development models, partnering with sponsors, regional teams, and cross-functional stakeholders to drive study start-up, trial execution, and operational excellence across global clinical programs. Key Contributions • Led global study start-up and activation strategies, partnering with sponsors, regional country teams, and operational functions to achieve aggressive activation timelines and accelerate study delivery. • Directed and influenced geographically dispersed teams of Regional and Country Trial Managers, providing strategic guidance, issue resolution, and operational leadership across multiple countries and time zones. • Served as a trusted sponsor-facing leader, translating strategic objectives into executable operational plans while ensuring alignment of timelines, quality standards, and business goals. • Successfully delivered site activation milestones through proactive risk identification, performance management, and cross-functional coordination, enabling studies to progress according to development timelines. • Managed complex global stakeholder relationships, frequently coordinating activities across multiple regions and operating outside traditional business hours to ensure continuity of execution and timely decision-making. • Provided operational oversight across multiple therapeutic areas, ensuring consistent delivery of study objectives, regulatory commitments, enrollment goals, and quality expectations. • Drove collaboration between Clinical Operations, Regulatory Affairs, Data Management, Medical, and external partners to proactively address study challenges and optimize trial performance. • Established a reputation for strong leadership, accountability, and partnership, supporting successful study execution in both sponsor-dedicated and full-service CRO environments.

Provided global operational leadership for a multinational metastatic colorectal cancer (mCRC) oncology study, overseeing execution from feasibility and study start-up through database lock, clinical study report (CSR), and program closeout. Key Contributions • Directed end-to-end study execution across global regions, ensuring alignment of timelines, quality standards, regulatory requirements, and operational objectives throughout the clinical trial lifecycle. • Led cross-functional teams spanning Clinical Operations, Data Management, Biostatistics, Medical Writing, Regulatory Affairs, and external vendors to successfully deliver all study milestones from feasibility through final CSR. • Developed and maintained strong partnerships with investigative sites, fostering a collaborative operating environment that enhanced site engagement, responsiveness, and overall study performance. • Implemented proactive study management and issue resolution strategies that minimized operational risk, maintained data quality, and supported efficient study execution. • Drove operational excellence through rigorous oversight of study conduct, resulting in a highly organized and inspection-ready trial environment. • Earned recognition from Medical Writing leadership for delivering one of the highest-quality and most operationally sound studies reviewed, facilitating an efficient and streamlined CSR development process. • Built strong credibility and trust with participating sites through transparent communication, responsiveness, and partnership-focused leadership, generating positive investigator feedback and strengthening site willingness to participate in future Pfizer clinical research programs. • Successfully delivered a complete and high-quality clinical trial package from feasibility through CSR despite challenging clinical outcomes, ensuring reliable data generation and supporting informed program decision-making.

Conducted ongoing review and analysis of clinical trial data to ensure subject safety, data quality, and protocol compliance for primarily Phase I and II oncology studies ( AML, CLL, NHL, MDS) Identified data trends, inconsistencies, and potential safety signals through routine review of clinical, laboratory, and efficacy data. Collaborated with Medical Monitors, Clinical Operations, Data Management, and Biostatistics to resolve data issues and support study execution for primarily Phase 1 and II oncology studies Participated in data review meetings and contributed to risk assessment, issue escalation, and mitigation strategies. Supported development of data review plans, study reports, and clinical study documentation. Assisted with database lock activities, data cleaning efforts, and preparation for interim and final analyses. Ensured adherence to GCP, regulatory requirements, and company SOPs throughout the clinical trial lifecycle