About the role

The Director, Clinical Trial Portfolio Management is a senior program and portfolio management leader within the PMO function, responsible for developing and maintaining the integrated portfolio view across clinical programs and cross-functional workstreams required to deliver the clinical, registrational, and lifecycle strategy. The role provides leadership with clear visibility into how programs, milestones, risks, dependencies, and workstreams support near-term regulatory objectives, future approvals, label expansion, and longer-range portfolio priorities.

This position works in close partnership with Clinical Leadership, Clinical Operations, Medical, and cross-functional leaders, serving as an integrated portfolio partner who connects strategy, execution planning, governance, and decision-making across functions. The role translates strategy into integrated plans, governance forums, timelines, dependencies, risks, and decision points that connect Clinical Development, Clinical Operations, Regulatory, Medical Writing, CMC, Safety/PV, Biometrics, Data Management, Quality, Medical Affairs, and Commercial.

The ideal candidate has demonstrated experience supporting registrational and lifecycle clinical programs in biotechnology or pharmaceutical environments, partnering with cross-functional leaders, supporting global health authority readiness, managing integrated plans, risks, governance forums, budgets, and submission-readiness milestones, and translating long-range strategy into disciplined execution over a multi-year planning horizon.

Essential Functions

Program Strategy & Integrated Development Planning

• Develop and maintain the integrated development plans across registrational and lifecycle clinical programs, ensuring alignment with corporate strategy, target product profile, evidence generation objectives, and key value drivers.
• Establish and maintain critical path timelines, milestones, decision points, dependencies, and cross-functional deliverables across clinical, regulatory, CMC, safety, biometrics, quality, medical writing, and commercial workstreams.
• Proactively identify program risks, opportunities, contingencies, and trade-offs that may affect registrational success, submission readiness, budget, resources, or timing.

Strategy-to-Execution Translation & Registrational Readiness

• Translate program strategy into actionable, cross-functional execution plans so clinical trials support registrational success, lifecycle planning, and future development priorities across geographies.
• Partner with Regulatory Affairs, Medical Writing, Clinical Development, Biometrics, CMC, Safety/PV, Quality, and Clinical Operations to ensure protocols, SAPs, CSRs, submission documents, datasets, supply plans, safety obligations, and inspection-readiness activities are planned with submission readiness in mind from inception.
• Define and manage the cross-functional submission readiness roadmap, aligning functions to key milestones such as database lock, CSR completion, module readiness, labeling inputs, filing readiness, and global expansion requirements.

Cross-Functional Program Leadership

• Lead and integrate matrixed teams across Clinical Development, Clinical Operations, Regulatory, Medical Writing, Safety/PV, CMC, Biometrics, Data Management, Quality, Medical Affairs, and Commercial to maintain one cohesive program plan.
• Drive alignment across functional strategies, resolve cross-functional conflicts, maintain decision clarity, and ensure functional deliverables support program-level milestones and submission readiness.
• Hold functions accountable to agreed timelines, dependencies, risks, actions, decisions, and governance commitments while escalating program-level issues in a timely and structured manner.

Governance, Risk, Budget & Portfolio Management

• Support program governance on behalf of the PMO function, including meeting cadence, decision framing, scenario planning, executive updates, risk documentation, action tracking, and timely escalation.
• Maintain living program risk registers and contingency plans across strategic, regulatory, operational, safety, supply, quality, budget, and commercial dimensions.
• Partner with Finance and functional leaders to support multi-trial budget forecasting, resource planning, trade-off decisions, and portfolio-level visibility.

Inspection Readiness, Operational Excellence & Continuous Improvement

• Partner with Quality Assurance and cross-functional teams to support continuous inspection readiness across sponsor functions, vendors, and clinical sites for relevant health authority inspections, including BIMO, pre-approval, and other inspection-readiness activities tied to current and future development programs.
• Contribute to continuous improvement of portfolio management practices, governance tools, integrated planning templates, dashboards, and lessons-learned processes across the PMO function.

Qualifications

• Bachelor's degree in life sciences, biological sciences, pharmacy, nursing, engineering, or a related scientific discipline required; equivalent relevant experience may be considered
• 10-15+ years of progressive experience in pharmaceutical, biotechnology, or related industry, with significant experience in clinical development, program management, clinical project management, or portfolio management at the program or portfolio level.
• Experience supporting registrational, Phase 2/3, pivotal, or submission-enabling clinical programs, with demonstrated ability to manage integrated timelines, risks, decisions, dependencies, and governance forums.
• Working understanding of clinical development, global regulatory pathways, IND/BLA/NDA/MAA submission planning, GCP expectations, and the role of protocols, SAPs, CSRs, datasets, labeling, and module-level submission readiness.
• Proven ability to translate complex clinical, regulatory, CMC, safety, quality, and operational strategy into executable cross-functional plans, dashboards, and governance materials.
• Strong stakeholder management and influence skills, including the ability to align senior functional leaders, surface trade-offs, and drive timely decision-making in a matrixed environment.
• Experience supporting program risk management, budget tracking, resource planning, executive-level reporting, and inspection-readiness documentation.

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
• 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 2026 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 2 x base salary + Voluntary Plans
• ADDITIONAL EXCLUSIVE BENEFITS - Voluntary Legal, Pet, Plus More