Heather Ronemus, RN, BSN, MSN

ICON plc (Genentech) • Led Investigator Initiated Studies (IIS) across hematology and multiple oncology indications (GI, CNS, dermatology, breast, prostate, and thyroid) spanning Phase I–IV trials. • Served as strategic operational lead for a 500+ study IIS portfolio, partnering with senior leadership to define strategy, execution plans, and operational priorities. • Managed 80+ budgets totaling upwards of $90 million, as well as resource forecasts, and integrated timelines across various therapeutic areas to ensure program delivery. • Evaluated critical path scenarios and challenged existing assumptions to improve operational robustness, implementing a streamlined contract submission and intake process that reduced turnaround time by 100% and accelerated overall contracting timelines. • Oversaw high-impact collaborations, including SU2C Catalyst and Rare Tumor Oncology/Hematology alliances, enabling innovative, and high-risk research in areas of unmet need. • Directed cross-functional teams across Clinical, Safety, Regulatory and Legal partners to drive alignment. • Proactively identified and mitigated program risks, including scope changes, resource constraints, and timeline challenges. • Delivered executive-level reporting with clear insight into risks, issues, and mitigation strategies to support informed decision-making. • Ensured accurate and compliant documentation of decisions, actions, and scope changes within management systems. • Coordinated portfolio updates and communications for senior leadership and governance forums. • Mentored and trained 20+ Clinical Study Managers, enhancing team capability and driving consistent operational excellence.

ICON plc (Genentech) • Led cross-functional execution of 100+ Investigator Initiated Studies (IIS) across GI, CNS, and Dermatology indications spanning multiple phases. • Managed timelines, budgets, scope, and documentation, ensuring alignment with Medical Affairs, Safety, and Regulatory stakeholders. • Performed portfolio-level reviews to drive high-quality reporting, consistent decision-making, and documentation integrity. • Proactively identified risks and issues, implementing mitigation strategies to maintain timelines and program continuity. • Ensured all program activities, decisions, and documentation met internal standards and regulatory compliance requirements.

• Led operational delivery of Phase II–IV clinical programs, overseeing budgets, timeline forecasting, and execution. • Navigated complex program transitions post-acquisition, aligning Finance, Clinical, and CRO partners to ensure continuity and optimal performance. • Presented operational and scientific insights to advisory boards and senior leadership, influencing key program decisions. • Ensured accuracy, quality, and audit readiness of critical study documentation in compliance with regulatory standards. • Reduced projected startup costs by approximately $500K by limiting upfront fees for a high-risk clinical study with low regulatory approval likelihood, while ensuring contractual and operational obligations were met.

• Directed global operational delivery for Phase I and IV clinical programs across Neuroscience and Hematology indications. • Identified and corrected a drug cost calculation error, delivering approximately $1M in savings for Medical Affairs. • Managed program budgets, timelines, and cross-functional execution across geographically dispersed teams. • Led investigator meetings, CRA training initiatives, and CRO/vendor oversight to ensure consistent study execution. • Maintained high-quality documentation, decision tracking, and full compliance with ICH/GCP standards. • Managed the Neuroscience Investigator Initiated Studies (IIS) program, supporting strategic study execution and oversight.