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.

We invite you to review our website to learn more about our company and team by visiting our website at https://www.cgoncology.com/careers/#overview.

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Role: Senior Manager, Clinical Supply Chain

Location: Remote US-Based

Essential Functions:

• Oversees and manages Clinical Supply Chain end to end activities from vial to clinical sites, including planning, labeling, packaging and distribution of Investigational Product (IP) for multiple clinical trials.
• Meticulous management of IP inventory levels at depots and clinical sites through the life of a trial; proactively mitigates potential supply issues at clinical sites while preventing excess product loss.
• Develop packaging and supply strategies to maximize supply efficiency, minimize waste while identifying risk and develop risk mitigation plans.
• Oversight of clinical supply third party vendors, including communication of project requirements, management of project execution, review of quotes and invoices.
• Manages and resolves supply chain related issues such as import/export, temperature excursion events during cold chain shipping and storage, and other time sensitive issues.
• Ensures accurate inventory records at all depots through timely reconciliation review and checks.
• Tracks metrics related to drug supply processes.
• May support, mentor and/or manage subordinate staff.
• Works with Clinical and CMC teams to develop clinical supply forecasts, supply plans, and timelines.
• Develops and manages clinical trial IRT systems including vendor selection, specification development, UAT execution, ongoing system administration.
• Reinforces the Supply Chain team’s development of global supply and procurement strategies including RFP development, vendor selection and auditing activities.
• Partners with Finance to develop budgets and manage costs for clinical supply activities.
• Provides input to the development of IP-related study documents including study and pharmacy manuals, training slides and documentation.
• Contributes to ongoing clinical supply chain gap analysis and process improvement initiatives.
• Partners with cross functional team including Clinical Operations, Regulatory Affairs, CMC and QA.
• Exhibits a solid understanding of clinical study design, execution, and impact of study drug supply. Familiarity with various clinical trial designs (randomized, double-blind, etc.).
• Support or lead other clinical and/or commercial supply chain activities, such as ancillary material assessment and procurement.
• Excellent knowledge of GxPs and Quality practices with close attention to good documentation practices.
• Reviews Master Service Agreements (MSA) and facilitates Legal review.
• Excellent verbal and email communication and presentation skills to internal stakeholders (Core Teams, Management Team, etc.).
• Performs other related duties as assigned or requested.

Qualifications:

• Bachelor’s Degree in a scientific field.
• Seven (7) years of relevant management supply chain experience in the pharmaceutical industry including supply planning, CMO oversight, project management, labeling and packaging, and/or logistics/distribution.
• Experience with biologics (sterile products), cold chain logistics, and product administration.
• Proficient knowledge of Microsoft Excel, PowerPoint & Project software.

The U.S. target annual salary range for this remote, full-time, position is currently set at $160,000-$170,000. The actual base salary offered for this role will vary depending on job-related knowledge, skills, market factors, experience and considering internal equity. In addition, to the base salary, CG Oncology offers a very attractive set of Total Rewards (including bonus and equity) and Well-Being Benefits provided as part of the overall compensation package for this role.

Please visit https://www.cgoncology.com/careers/#rewards for a listing of these rewards and benefits.

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 the 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 - Unlimited Paid Time Off (PTO)
• HOLIDAYS – We observe 12 Holidays/year
• RETIREMENT – 401K with 100% company Safe Harbor match up to 4% of base salary
• HEALTH (MEDICAL, DENTAL, VISION) – HMOs, PPOs & HDHP – Anthem/MetLife
• 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.

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.