Job Description

A re 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 Medical Director (Monitor) will utilize their medical and drug development experience to oversee the conduct and evaluation of clinical trials of cancer immunotherapeutics. Responsibilities will include but are not limited to education and support of clinical study sites, assessment of drug safety, communication and collaboration with regulatory authorities, protocol design and amendments, data collection, review, and interpretation, as well as other aspects of study conduct, and oversight as needed. The successful candidate will be highly collaborative and work cross-functionally with key stakeholders and international partners as required.

Location: Remote

Essential Functions

• Collaborate with the Clinical Development, Clinical Operations, Regulatory, Pharmacovigilance, Medical Affairs and other applicable teams to develop protocol strategies, design and assist with development of both regulatory and study documents and any related scientific publications.
• Collaborate with external teams such as CROs or other vendors who provide services to support Clinical Development and CG Oncology clinical trials.
• Develop competency with all CG Oncology assets and studies to be able to provide coverage and support for other Medical Directors to achieve company goals.
• Responsible for assessing and overseeing study conduct in conjunction with Clinical Operations and interact with investigative sites to review and respond to protocol/medical questions regarding patient safety, patient evaluation, and protocol adherence.
• Review and approve final protocols and amendments in conjunction with clinical trial scientists. Coordinate with the study team to review and approve study processes and deliverables and participate in development of Case Report Forms (CRFs) and statistical analysis plans (SAPs).
• Ensure appropriate collection, review, and analysis of study data, in collaboration with Clinical Scientists, CRAs, CROs, and sites.
• Facilitate and respond to patient safety questions and review the applicable literature as needed.
• Review individual data with Serious Adverse Events (SAEs) and potentially clinically important laboratory test or vital sign abnormalities.
• Oversee and review protocol training, assist with the production of relevant materials, and deliver protocol training (as required/requested) during meetings.
• Review patient profiles, study level data review, and perform a review of data generated by data listings or statistical analyses for assigned studies, and present findings at quarterly drug safety reviews.
• Participate in all reviews and procedures required for database lock and will review all patient narratives.
• Review outstanding medical and/or GCP issues report and address issues across the study and provide the study team with medical expertise during key activities.
• Attend company meetings in person on a regular cadence biannually at minimum; in person attendance at sites to support study activities; attend regional or national scientific meetings.

Qualifications

• Medical Degree (MD) or equivalent degree program.
• 2-3 years of clinical development and medical monitoring experience in biotech/pharmaceuticals.
• Experience supporting multiple clinical trials.
• Strong medical/research/technical acumen.
• Flexible working hours to meet geographical needs – occasional early days and late evenings are expected.
• Ability to travel domestically/international as required.

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

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 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.

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