CG Oncology

Director

• Develop and execute Private Equity/IDNs/ Top LUGPAs Strategic Account Plans, establish engagement points and actions with appropriate stakeholders to map organizations interests and hierarchy.
• Remove barriers within Private Equity/IDNs/Large LUGPAs/VA/DoD to drive demand
• Facilitates strategic engagement between CG Oncology ELT/Senior stakeholders and key Private Equity/IDNs/Large LUGPAs/VA/DoD stakeholders
• Manage large geographies, identify opportunities and evolving trends across Private Equity/IDNs/Large LUGPAs/VA/DoD that are consistent with the goals of the YOLO Launch Strategic Imperatives
• Align Private Equity/IDNs/Large LUGPAs/VA/DoD with Local Market Strategy & Leadership
• Bridge alignment between the Health Systems Director and other field functions
• Long Term Strategic Focus and align the goals of the PEs/IDNs/Large LUGPAs with the goals of CG Oncology
• Lead, mobilize, and establish standing pull through and strategic account planning market meetings with market stakeholders
• Routinely communicate ongoing success, opportunities and identify new, unique and profitable business opportunities
• Ensure collaboration and partnership with field leadership, market access, marketing and operations to ensure best in class launch
• Inform the organization of trends and market insights, risks, opportunities for success etc.
• Inform and influence key opinion leaders (KOLs)
• Develop customer specific strategies, roadmap, segmentation, and account plans for all targeted accounts
• Build and maintain strong long-term customer relationships/partnerships that drive key initiatives related to our growth and success
• Collaborate with field teams (KAMs, FRM’s, Market Access, Medical Affairs, etc..) to monitor the market landscape to identify key trends, barriers, and partner with colleagues to mitigate.

Health Systems Director

Financial Planning and Analysis

• Lead the Company's financial planning, forecasting, strategic analysis, and business partnering functions.
• Serve as a key partner to the VP FP&A and executive leadership team, providing financial leadership to support R&D and Technical operations strategy, operational execution, commercialization readiness, and long-term value creation.
• Oversee enterprise budgeting, long-range planning, cash forecasting, Board reporting, and strategic decision support while building scalable financial processes and capabilities to support the Company's growth.
• Lead enterprise-wide annual operating planning, long-range planning, and rolling forecast processes for all R&D and Tech Ops functions.
• Develop financial frameworks that support strategic decision-making and capital allocation.
• Translate corporate strategy into actionable financial plans and performance metrics.
• Partner with executive leadership to evaluate strategic alternatives and growth opportunities.
• Assist VP FP&A with preparation of financial materials for Executive Leadership Team, Board of Directors, Audit Committee, and external stakeholders.
• Deliver actionable insights regarding operating performance, cash runway, and strategic initiatives.
• Own cash forecasting and liquidity planning processes for R&D and Tech Ops.
• Assist VP FP&A on financing initiatives and capital strategy.
• Assess investment opportunities and resource prioritization across the organization.
• Assist VP FP&A and CFO with financial due diligence and valuation support for business development, licensing, M&A, and partnership opportunities.

Director, Financial Planning – Analysis

Recruitment

• The Sr. Manager of Talent Acquisition is a hands-on recruiting leader responsible for driving high-quality hiring outcomes across commercial, clinical, and corporate functions
• Lead full-cycle recruiting, targeted sourcing, and hiring process execution
• Partner with the Senior Director of Talent Acquisition & HRBP, enterprise business leaders, and HRBPs to develop and execute recruiting and sourcing strategies aligned with workforce planning and growth objectives
• Forecast hiring needs and proactively build pipelines to support current and future talent demands
• Ensure a positive, seamless, and consistent experience for all candidates and hiring managers
• Implement and scale performance-based hiring methodologies and tools
• Develop and ensure consistent use of scorecards and structured interview processes
• Track, analyze, and report on recruiting metrics including pipeline health, time-to-fill, and quality-of hire

Senior Manager, Talent Acquisition

QA Engineer

• The Senior Specialist, Quality Assurance – Drug Product is responsible for executing quality assurance activities that support clinical and commercial manufacturing operations in compliance with cGMP standards.
• This role focuses on batch record review, vendor oversight, and ensuring the accuracy and completeness of GMP documentation across internal and external manufacturing operations.
• The individual will work closely with contract manufacturers to support tech transfer, process validation, and routine GMP operations.
• Success in this role requires strong attention to detail, the ability to manage multiple priorities, and effective cross functional collaboration to ensure timely batch disposition and compliance.
• The position serves as a key contributor within the QA team, supporting inspection readiness and the ongoing operation and continuous improvement of the GMP Quality System, while also providing occasional support for clinical labeling, drug substance contract manufacturing, and other QA activities as needed.

Senior Specialist, Quality Assurance – Drug Product

• Guide Study Design and Execution of Clinical Trials
• Provide statistical leadership and oversight for Phase 1-3 clinical trials.
• Contribute to and lead statistical aspects of study design activities including endpoint selection, sample size determination, randomization strategies, interim analyses, and statistical methodologies.
• Partner with Clinical Development and Clinical Operations to ensure study objectives, statistical assumptions, and operational execution are aligned.
• Review and provide input on protocols, protocol amendments, study conduct, and trial execution to ensure scientific rigor and regulatory acceptability.
• Support Data Monitoring Committees (DMCs), Safety Review Committees, and other governance bodies as needed.
• Author/Review Regulatory Documents and Support Regulatory Strategies
• Lead or contribute to the development and review of SAPs, protocols, CSRs, and regulatory submission documents.
• Support statistical contributions to regulatory interactions, including preparation for meetings with FDA and international health authorities.
• Contribute to regulatory strategy by ensuring statistical approaches align with applicable regulatory guidance and expectations.
• Support preparation of responses to regulatory questions, information requests, and health authority meetings.
• Ensure statistical deliverables meet quality, compliance, and submission readiness standards.
• Data Interpretation and Support Decision Making
• Interpret and communicate clinical trial results to cross-functional teams and functional leadership.
• Translate complex statistical findings into clear, actionable insights that inform development strategy and business decisions.
• Contribute statistical input into benefit-risk assessments, program evaluations, and clinical development planning.
• Support publication strategies, scientific presentations, and external communications by ensuring accurate interpretation of statistical results.
• Present statistical analyses and recommendations to cross-functional teams and governance committees.
• Process Improvements
• Identify opportunities to enhance efficiency, quality, and consistency across biostatistical processes and deliverables.
• Contribute to the development and implementation of standards, templates, and best practices.
• Promote innovative statistical methodologies, data visualization approaches, and analytical tools.
• Contribute to inspection readiness initiatives and continuous improvement of quality systems.
• Promote statistical integrity, reproducibility, and compliance with industry and regulatory standards.
• Oversee CROs and External Partners
• Provide oversight and management of CRO statisticians, statistical programmers, and other external vendors.
• Review and QC vendor deliverables to ensure quality, scientific accuracy, regulatory compliance, and adherence to timelines.
• Establish expectations, monitor performance, and proactively manage risks related to outsourced statistical activities.
• Serve as a key statistical representative for external partners and ensure alignment with program objectives.
• Support vendor selection, budgeting, and resource planning activities as needed.
• Mentor Team Members
• Provide technical guidance, coaching, and mentorship to statisticians and cross-functional team members.
• Foster a culture of collaboration, accountability, scientific excellence, and continuous learning.
• Support talent development through training, knowledge sharing, and professional growth opportunities.
• Support departmental resource planning and knowledge-sharing initiatives.
• Serve as a role model for leadership, collaboration, and effective communication across the organization.

Associate Director – Biostatistics

Software Engineer

• Provide technical leadership for statistical programming activities across multiple clinical development programs
• Lead the development, validation, and maintenance of SDTM and ADaM in accordance with CDISC standards and regulatory requirements
• Oversee creation and maintenance of specifications, Define.xml packages, and submission-ready deliverables
• Ensure programming deliverables support study objectives, statistical analyses, and regulatory submission requirements
• Serve as the programming subject matter expert for complex analyses, integrated summaries, and submission activities
• Develop and review analysis datasets, tables, listings, figures (TLFs), patient profiles, and ad hoc analyses
• Ensure programming deliverables meet quality, traceability, reproducibility, and regulatory compliance standards
• Establish and maintain programming specifications, validation plans, and quality control procedures
• Lead implementation and governance of SDTM, ADaM, and Define.xml standards across development programs
• Evaluate evolving industry standards and regulatory guidance and implement best practices within the organization
• Drive continuous improvement initiatives across statistical programming processes and systems
• Review vendor deliverables for quality, consistency, regulatory compliance, and adherence to timelines
• Mentor and develop team members, leading training initiatives related to CDISC standards, programming methodologies, validation practices, and submission requirements

Senior Principal Programmer

• Establish and drive the global quality strategy aligned with corporate objectives, regulatory expectations, and risk-based approaches to product development and commercialization.
• Develop and lead quality strategy across the product lifecycle (clinical to commercial), ensuring operational excellence, phase-appropriate quality systems, and regulatory compliance.
• Represent Quality in strategic discussions and business planning across Technical Operations, Regulatory, and the Executive Leadership Team (ELT).
• Serve as quality SME for manufacturing campaigns, CMC strategy, and regulatory submissions (e.g., IND, BLA, supplements).
• Lead quality input for QTPP, CQA assessments, control strategies, stability programs, and product specifications.

Senior Director, Quality Control

• Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements.
• Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness.
• Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities.
• Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution.
• Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards.
• Support timely disposition activities once all required data is available.
• Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities.
• Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings.
• Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations.
• Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations.