Director, Medical Information

Are you ready to make a difference in the world and become part of our patient-centered team that is focused on Attacking Bladder Cancer for a Better Tomorrow? At CG Oncology, we believe that by having exceptionally talented individuals on our team who share our passion and enjoy working together, we can truly achieve our Vision and Mission to benefit patients around the world. Every day we are making significant advancements across our multiple pipelines and are growing rapidly to meet the needs of our patients who cannot afford to wait to benefit from our novel immunotherapies. Please review this job posting and our Values and if they resonate with you and are what you expect from your organization and team, then we would like to hear from you. About the role The Director, Medical Information will provide strategic leadership for the development, governance, and delivery of Medical Information across CG Oncology's portfolio. This role will build and scale a compliant, responsive Medical Information capability that delivers accurate, balanced, and scientifically rigorous information to healthcare professionals, patients, payers, and other stakeholders. As a key member of Medical Affairs, the Director will lead the development and lifecycle management of core Medical Information content, oversee outsourced Medical Information operations via the call center, generate actionable insights from inquiry trends, and partner cross-functionally to support launch readiness, lifecycle management, market access, Scientific Communications, and Field Medical activities. The ideal candidate combines deep scientific expertise, operational excellence, and an innovation mindset to modernize Medical Information capabilities through process optimization, digital transformation, and appropriately governed AI-enabled solutions while ensuring adherence to applicable regulations, guidance, and company policies. Essential Functions Define and execute the Medical Information strategy in alignment with Medical Affairs and corporate objectives. Build scalable Medical Information capabilities to support product launch readiness, lifecycle management, and organizational growth. Lead the strategy, governance, and execution of Medical Information activities, ensuring timely, accurate, balanced, and compliant responses to unsolicited inquiries. Establish and oversee lifecycle management of Medical Information content, including standard response letters (SRL), frequently asked questions (FAQs), medical narratives, payer‑facing scientific resources, and other approved materials. Direct the resolution of complex or novel medical inquiries and serve as a product and disease-state subject matter expert for internal and external stakeholders. Provide strategic oversight of Medical Information vendors and call center, including onboarding and training, performance management, quality monitoring, issue escalation, compliance governance, and budget stewardship. Lead Medical Information launch readiness, including content planning, inquiry response models, contact‑center training, systems and workflow readiness, and cross‑functional alignment. Analyze inquiry trends and operational metrics to identify actionable scientific and stakeholder insights; communicate recommendations to Medical Affairs, Clinical Development, Safety, Regulatory, Market Access, and other relevant functions. Represent Medical Information on cross‑functional launch, medical strategy, market access, and other portfolio initiatives. Support Medical Affairs activities at scientific congresses and professional meetings, including Medical Information booth coverage and development or review of congress materials. Provide compliant scientific support for payer and market access activities, as needed. Develop and maintain Medical Information policies, guidelines, SOPs, quality controls, and inspection‑ready documentation consistent with applicable requirements and company standards. Identify and implement continuous‑improvement initiatives that enhance Medical Information quality, efficiency, scalability, and stakeholder experience. Evaluate and support responsible adoption of digital and AI‑enabled solutions for content development, knowledge management, workflow automation, analytics, and operational efficiency. Qualifications Advanced scientific or healthcare degree (PharmD, PhD, MD, or equivalent) required. Ten (10) years of experience in the pharmaceutical, biotechnology, or healthcare industry, including substantial experience in Medical Information or Medical Affairs. 4-5 years of direct Medical Information experience. Demonstrated experience leading Medical Information programs, content strategy, and operational delivery. Strong knowledge of requirements and industry standards governing dissemination of medical information and non‑promotional scientific communications. Experience leading cross‑functional initiatives and influencing stakeholders in a matrixed environment. Experience overseeing Medical Information vendors or external service providers, including quality and performance management. Demonstrated ability to critically evaluate clinical evidence and communicate complex scientific information accurately and clearly. Strong analytical, project management, and organizational skills, with the ability to manage multiple priorities in a fast‑paced environment. Excellent written and verbal communication skills, including communication with senior leaders and external stakeholders. Demonstrated experience establishing, scaling or materially enhancing a Medical Information capability. Experience developing Medical Information operating models, processes, systems, SOPs and governance. Experience supporting late‑stage development, commercialization readiness or product launch. Developing and managing standard response letters, FAQs and other scientific response content. Establishing content‑development, review, approval, maintenance and retirement processes. Experience moving Medical Information content through Medical, Legal and Regulatory review. Work Authorization: Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time. Please note that CG Oncology does not accept unsolicited information and/or resumes from search firms or agencies for our job postings. Any resumes or client information submitted to our careers page or any employee of CG Oncology by any search firm or agency without an applicable contract in place will become the property of CG Oncology and no fee(s) will be paid. Total Rewards CG Oncology offers very competitive and comprehensive Total Rewards, helping to support and reward our global team of high‑performing employees focused on developing bladder‑saving therapeutics for patients afflicted with bladder cancer. HIGHLY COMPETITIVE SALARIES ANNUAL PERFORMANCE/MERIT REVIEWS ANNUAL PERFORMANCE BONUSES EQUITYSPECIAL RECOGNITION In addition to our Total Rewards, CG Oncology offers a variety of Well‑Being Benefits to meet the majority of the needs of our unique and growing workforce. These benefits are designed to support our team to achieve a healthy balance between work and their personal lives to remain refreshed, engaged, and creating an environment where each person can find a deeper meaning and purpose in their work. Well‑Being Benefits eligibility begins the 1st of the month after hire. While a majority of these benefits are for our US‑based workforce, we continue to assess comparable levels of benefits for our international team members that are aligned with country‑specific regulations and their national programs offered. FULLY REMOTE WORK ENVIRONMENT REST AND RECHARGE BENEFITS - Unlimited Flexible Time Off HOLIDAYS - In 2026 we will observe 14 holidays RETIREMENT - 401K with 100% company Safe Harbor match up to 4% of base salary HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC ILLNESS & DISABILITY PROTECTION - Company Paid LTD Coverage + Voluntary Plans LIFE INSURANCE - Company Paid 2 x base salary + Voluntary Plans ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More CG Oncology is an Equal Opportunity Employer: All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. At CG Oncology, we are building a community of intelligent and passionate team members that share our Vision, Mission and Values, and while the biotechnology space can feel limited in BIPOC, non‑binary and even female representation, we endeavor to make hiring decisions that will continue to grow and support our team in the direction of maintaining cultural diversity and sustainability. #J-18808-Ljbffr CG Oncology, Inc.