The work, in full.

Built and led the clinical operations function for a clinical-stage immuno-oncology biotech — establishing the entire infrastructure from scratch while overseeing a Phase I/II program through dose escalation and expansion cohorts.

• Scientific Leadership: Co-authored 10+ peer-reviewed abstracts and posters at ASCO, SITC, and AACR (2023–2024) — elevating program credibility with global key opinion leaders and demonstrating an unusual dual contribution for an operations executive.
• Program Buildout: Established SOPs, CRO framework, and TMF from the ground up, enabling rapid site activation for a first-in-class immuno-oncology asset in a resource-constrained biotech environment.
• Cross-Functional Alignment: Chaired oversight committee spanning Clinical Development, Preclinical, CMC, and Regulatory — keeping all functions synchronized with corporate milestones and board-level objectives.
• Vendor & Budget Control: Directed CRO selection and ongoing performance management; oversaw clinical trial material forecasting and full study budget across multi-year execution.

Recruited to lead global clinical operations for a Precision Medicine-focused oncology biotech targeting a rare disease indication — where a narrow biomarker-selected patient population demanded a highly sophisticated multinational site strategy.

• Rare Disease Enrollment: Engineered site feasibility and patient recruitment strategy for adenoid cystic carcinoma, navigating the specialist-center landscape to make enrollment viable across international geographies.
• Risk Management: Proactively identified and resolved program risks across CRO performance, supply chain, and regulatory timelines — maintaining deliverables and cost targets through structured trade-off decisions.
• Cross-Functional Partnership: Aligned Regulatory Affairs, CMC, and Project Management around a unified execution roadmap, improving handoff efficiency and reducing cycle time on key deliverables.

Directed simultaneous clinical programs across immuno-oncology, orphan disease, and rheumatology — one of the broadest multi-indication portfolios managed by a single ops leader at the company over a five-year tenure.

• Multi-Program Delivery: Oversaw concurrent active trials across 3 therapeutic areas, ensuring all programs met or exceeded ICH/GCP standards and clinical development plan milestones throughout a five-year tenure.
• Regulatory Authorship: Contributed to IND, NDA/BLA, and MAA submissions — authoring protocols, Investigator Brochures, and interim study reports that advanced multiple assets through the regulatory pathway.
• Contract Execution: Negotiated CRO and vendor contracts and administered all trial budgets in partnership with legal — consistently delivering on scope and cost across a multi-year, multi-program portfolio.

Hand-selected to lead strategic lifecycle planning for two of the three highest-priority global oncology compounds, managing a 14-person team across trial design, execution, and evaluation.

• Portfolio Priority: Led lifecycle strategy for the #1 and #2 oncology compounds in Astellas' global R&D pipeline, coordinating cross-regional teams across design, implementation, and evaluation phases.
• People Leadership: Directly managed 14 clinical study staff; collaborated with R&D leadership on resource allocation to optimize team deployment across competing program demands.

Served as Global Clinical Operations lead for the Hematology/Oncology portfolio — 8 compounds, 20 concurrent studies, $180M in programmatic assets.

• Portfolio Scale: Administered $180M across 8 compounds and 20 studies; mentored 8 Senior Study Managers across 3 regional offices, driving global consistency in execution quality and compliance standards.
• Speed to Activation: Opened 3 oncology studies for patient accrual within 9 weeks of final protocol delivery — compressing a milestone that typically requires 4–6 months and setting a new benchmark within the organization.