Dawn Payne M.S. PMP

Lead project management and operational execution for small molecule and biologics CMC programs, supporting assets across early development through commercial lifecycle management. Provided strategic oversight for multiple concurrent development and commercial programs, ensuring alignment across CMC timelines, resource plans, budgets, and risk mitigation strategies. Served as a strategic PM partner across Process Development, Formulations, Analytical Operations, Quality Assurance, Regulatory Affairs, Packaging & Labeling, Global Supply Chain, and Outsourcing, enabling integrated decision-making. Drive end-to-end program governance, including preparation for Project Reviews, Commercial CMC Reviews, Tech Development Reviews, and PNGC meetings, ensuring leadership-ready materials and aligned team narratives. Oversaw activities supporting supply continuity, inspection readiness, and change management, partnering with Quality and Supply Chain to maintain compliance for commercial products. Manage internal teams and external CMOs and vendors, ensuring execution against milestones, issue resolution, and accountability across complex networks. Lead and contributed to PMO-wide initiatives, including adoption of best practices, modernization of documentation standards, and development of internal training content. Translated complex CMC, regulatory, and technical input from subject matter experts into clear, actionable strategies for senior leadership and portfolio teams.

Managed execution of up to 9 concurrent CMC programs spanning Phase 1, Phase 2, and commercial assets, supporting small molecule development from IND through commercialization. Maintained and integrated CMC timelines, resource plans, budget tracking, risk registers, and action items, proactively identifying critical path risks and driving corrective actions. Collaborated across Process Chemistry, Formulations, Analytical, Quality Assurance, Regulatory CMC, Global Supply Chain, Packaging, and Commercial Manufacturing to deliver program milestones. Led project risk identification and mitigation efforts, including support for nitrosamine risk evaluations, CAPA initiation and closure, and strategic scenario planning aligned with program context. Prepared teams for governance and portfolio reviews, ensuring high-quality documentation, aligned messaging, and readiness for senior leadership decision-making. Played a key role in portfolio reporting, providing regular updates to PDM Portfolio Teams and Leadership Teams on program status, risks, and execution progress. Contributed to and led PMO initiatives, including Long Range Resource Planning, Meeting Optimization, and modernization of project management best practices. Led the PDM PM Training Refresh and PM Academy content updates, strengthening organizational capability and onboarding effectiveness. Supported organizational initiatives including CARES Act reporting and optimization, contributing to efforts that secured $0.5M in funding for continued improvements. Led the PDM Refresh workstream, resulting in leadership approval for Phase 2 execution.

Served as a key liaison between biopharma clients and internal scientific, data, and biometrics teams, supporting delivery of translational and biomarker-driven programs. Supported project leads by developing and maintaining project plans, data specifications, reports, dashboards, and stakeholder communications across the project lifecycle. Conducted financial forecasting, budget tracking, and resource planning for assigned projects to support accurate delivery and client expectations. Coordinated Scientific Steering Committee meetings, including agenda development, materials preparation, and follow-up action tracking with senior stakeholders. Initiated and managed change orders for expanded Biomarker Data Management services, ensuring scope clarity and alignment with contractual requirements. Ensured all activities were executed in accordance with best practices, SOPs, and quality standards in regulated research environments.

Managed clinical trial start-up activities for sponsor-led studies, including IRB submissions and regulatory documentation. Acted as a primary liaison between Principal Investigators, sponsors, and study teams, ensuring protocol adherence and clear communication. Supported patient recruitment and enrollment, ensuring compliance with eligibility criteria, HIPAA, and GCP requirements. Performed accurate and timely data entry into electronic case report forms (IBM Clinical Development). Maintained high standards of data integrity, patient confidentiality, and regulatory compliance throughout trial execution.

Supported national healthcare initiatives through a CMS-funded Transforming Clinical Practice Initiative, focusing on clinician engagement and quality improvement. Led clinician recruitment, strategic planning, and deliverable submissions, supporting federal reporting and program milestones. Managed educational webinars, national meetings, interns, and consultant agreements, ensuring timely execution and stakeholder alignment. Developed learning plans, data collection strategies, executive presentations, and project documentation for leadership and external partners.

The Quality Improvement Organization (QIO) Program is the cornerstone of Medicare’s efforts to improve the quality of care and health outcomes for beneficiaries. Collaborated with KEPRO under the Medicare Quality Innovation Organization (QIO) Program to research and analyze Patient & Family Engagement (PFE) programs. Contributed to an Environmental Scan through data collection, interviews, analysis, and reporting on emerging healthcare engagement practices.

Patient-Centered Outcomes Research Institute (PCORI) Project is entitled "Changing the Healthcare Delivery Model: A Community Health Worker/Mobile Chronic Care Team Strategy”. This program provides a useful and affordable way to help individuals with Type 2 Diabetes stay healthy. My duties include: • Patient Recruitment • Obtaining patient information • Scheduling Meetings • Counseling patients • Organizing files/Documents • M3 Clinician screening of patients • Updating physicians on patient status

This study serves as a mechanism for patients to decrease their A1C through the use of technology. We developed a patient portal website and mobile application that aids in patient compliance. This application allowed patients to contact their specialist, have remote access to lab results, medication refills, appointments times, and learning resources. Patients from my PCORI study utilized this portal as a means for their diabetes management.

• Utilized apoptotic kits to evaluate role of programmed cell death in the growth, development and differentiation of tumor cell line HT-29 and correlating the incidence of apoptosis and necrosis of cell lines exposed to varying dosages of anti-mitotic extracts derived from medicinal plants. • Utilized flow cytometric studies and immunocytochemistry to evaluate the growth and cell cycle of HT-29 cell lines. • Exposure to Athymic animal studies (fixation and tissue Preparation) • Experience in Cell Culture (cell maintenance, cell dissociation, & media preparation)

• Maintained administrative functions within biology department to include; organization and maintenance of lab inventory; responsible for lab access and security; respond to staff and student inquires and utilized a variety of office equipment and MS office products