Senior Medical Director

About CG Oncology, Inc.

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 Senior Medical Director provides oversight, technical expertise, and leads the direction, planning, execution and interpretation of clinical trials, protocols, and data collection activities for multiple programs in the development portfolio. This individual establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Together with the Clinical Trial Managers and teams, may recruit clinical investigators and negotiate study design and costs. They will be responsible for directing human clinical trials, phases I – IV, for company products under development. They will work collaboratively, both internally and externally, to develop, implement, and oversee clinical trials working extensively with the Clinical Operations team, external advisers, investigators, and regulators to ensure clinical studies are executed using robust designs, conducted in relevant populations, and adhere to compliance standards for regulatory submissions. Responsibilities also include adverse event reporting and drug safety monitoring. Coordinates and develops information for reports submitted to the Food and Drug Administration and other health authorities. Monitors adherence to protocols and determines study completion. May act as consultant/liaison with other corporations when working under licensing agreements.

Location: Remote

Essential Functions

• Provides and oversees medical monitoring to multiple clinical trials.
• Lead project teams to design and implement clinical studies.
• Write protocols, investigator brochures, clinical study reports and review clinical trial documents.
• Conduct investigator meetings and lead site initiation visits with clinical trial investigators.
• Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets.
• Translate findings from research and nonclinical studies into clinical development opportunities.
• Interact with clinical investigators and thought leaders.
• Work with internal regulatory affairs team and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
• Work with internal pre-clinical scientists, translational scientists, safety physicians, business, and commercial organizations in a cross functional manner.
• Attends investigator and advisor meetings, when necessary, to enhance the awareness of studies and findings evaluating CG Oncology’s product portfolio.
• Establishes and maintains relationships with KOLs, clinical institutions, physician and clinical trial and demonstration project site investigators and research staff, third party clinical trial companies, disease advocacy groups, in furtherance of clinical evaluation of CG Oncology’s products pre and post launch.
• Oversees the development of clinical trial protocols, monitoring plans, CRF development working in concert with clinical trial scientists, Clinical Operations, Clinical Data Management, and statistical science.
• Actively engages with and works in partnership with QA/Regulatory Affairs, CMC/TechOps, and other ethical guidelines relevant to the pharmaceutical industry and ensure compliance with these external guidelines.
• Partners with the VP, Clinical Development and if needed, the CMO, on strategic planning activities by anticipating changing clinical needs a