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 and assessing the competitive landscape.
• Provide leadership of Medical Director team within Clinical Development, including the clear communication of objectives, the development of key strategies and tactics, and oversight of the team’s performance.
• Assists in assessing clinical study related expenditures, forecasting and planning.
• Supports Clinical Operations in clinical trial site start up and utilization.
• Perform other duties as required.

Qualifications

• M.D. or D.O. degree
• Ten (10) to twelve (12) years of relevant drug development experience, either within industry or as a clinical investigator/physician scientist in academia, or equivalent experience.
• Proven clinical development strategist with experience designing, implementing, and conducting clinical trials.
• Knowledge of carrying out clinical trials, including knowledge of current treatment landscapes; experience with clinical trials involving mono and combination immunotherapies.
• Available for approximately 25% travel both domestic and international, including overnight stays.
• Flexible work hours to accommodate meetings in the evenings.
• Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities

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
• EQUITY
• SPECIAL RECOGNITION

Well-Being Benefits

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 2025 we will observe 14 holidays
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – PPO & HDHP – Cigna/Principal
• HEALTH SPENDING ACCOUNTS - HSA (with Annual Company Contribution), FSA, FSA-DC
• ILLNESS & DISABILITY PROTECTION – Company Paid LTD Coverage + Voluntary Plans
• LIFE INSURANCE – Company Paid 1 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.