• Support the design and writing of clinical protocols and associated clinical study documents (e.g., ICFs, charters, operational manuals, etc.) • Serves as an expert on the clinical study design (including trial procedures and requirements) and develops training materials to ensure quality execution by the investigational sites. • Support cross-functional teams with study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures. • Engages clinical trial vendors to support study start-up activities in line with the clinical trial design • Provides medical monitoring support or oversight of activities conducted by a CRO, which includes monitoring, cleaning, analyzing, and reviewing efficacy data to establish the presence or absence of trends and follow up as appropriate • Collaborate on, or lead where appropriate, the writing of clinical sections of key program documents including Investigational New Drug submissions, Investigator Brochures, Clinical Study Reports, and other global regulatory submissions and responses. • Support clinical development planning by participating in the evaluation of innovative trial designs and provisioning and analyzing data from ongoing and/or completed clinical trials to support future planning • Maintaining awareness of internal and external developments (scientific, clinical, competitive, and regulatory) that could impact the development plan, including attendance at major scientific conferences, participation in competitive intelligence activities, and periodic literature review.

• Accountable for the delivery of studies or programs that are critical to a product’s clinical development, ensuring that they are completed on time, within budget and in compliance with SOPs, regulations and ICH/GCP guidelines • Performs all required management responsibilities including but not limited to: implementing the company's policies, programs, and guidelines; ensuring employee productivity and growth; managing resources; knowing Varian's business; and maintaining functional, technical, and external market awareness necessary for managing immediate organization. • Communicate study status, cost and issues to ensure timely decision-making by senior management • Initiate and manage study-level timelines, including communication to internal and external team members on deliverables • Oversee the creation of site materials including training, manuals and support documentation • Perform periodic review of clinical data, quality metrics and study deviations • Develop timelines and budgets for assigned studies/programs and is responsible for delivery to both quality and agreed timelines. • Develop and implement robust contingency and issue management plans to solve complex issues that impact study or program milestones. • Provides input into the development of study protocols and CRFs to ensure studies are designed and planned to be achievable

• Overseeing centralized patient recruitment operations across multiple clinical research sites. • Providing direct leadership and support to Central Recruiters engaged in phone-based patient outreach, screening, and scheduling. • Ensuring recruitment activities are accurate, compliant, patient-centered, and aligned with protocol, site, and sponsor requirements. • Serving as the primary operational escalation point for Central Recruiters. • Working closely with site teams and Patient Recruitment leadership to drive high-quality recruitment execution and continuous improvement.

• Provide statistical leadership for oncology clinical trials across multiple phases (Phase I–III). • Lead the development of statistical analysis plans (SAPs), protocols, and clinical study reports (CSRs). • Design and review statistical methodologies for efficacy and safety analyses. • Oversee analysis datasets (SDTM/ADaM) and TLFs in compliance with CDISC standards. • Support interim analyses, data monitoring committee (DMC) activities, and adaptive designs. • Collaborate with clinical development, data management, programming, regulatory, and medical teams. • Contribute to regulatory submissions (IND, NDA, BLA) and respond to health authority queries (FDA, EMA). • Provide strategic input on study design, endpoint selection, and sample size calculations. • Mentor junior statisticians and provide technical guidance.