Anh Tran
San Jose,CA
Summary
Accomplished Clinical Operations Leader with 20 years of experience managing global Phase I–III oncology and immuno-oncology programs from Pre-IND to NDA stages. Delivered significant reductions in timelines and budget savings across multi-million dollar portfolios. Fostered inspection-ready trials through strategic collaboration with leadership and regulatory teams, overseeing CROs and vendors to ensure timely, submission-ready data.
Overview
21
21
years of professional experience
Work History
Executive Director, Clinical Operations
Trishula Therapeutics, Inc
South San Francisco, CA
03.2023 - Current
- Spin-out from Tizona
Sr. Director, Clinical Operations
Trishula Therapeutics, Inc
South San Francisco, CA
08.2020 - 03.2023
- Leads global Clinical Operations for an oncology/immuno-oncology portfolio from program planning through database lock and submission readiness.
- Sets strategy, builds internal processes, governs CROs/vendors, and steers cross-functional execution, budget, quality, and risk management.
- Delivered portfolio critical path and acceleration plans, resulting in 8-week earlier enrollment timeline across Phase 1/2 studies.
- Established vendor governance with KPIs/KRIs, reducing protocol deviations and query aging through centralized data review while ensuring quality data oversight.
- Re-forecasted and optimized CRO/vendor budgets and performance, achieving maximum annual efficiencies.
- Simplified tech stack (EDC, IRT integrations); trimmed database-lock and site closures cycle time.
- Built scalable processes (start-up playbooks, risk-based quality, issue management) that shortened timelines ~15%.
- Spin-out from Tizona
Director, Clinical Operations
Tizona Therapeutics, Inc
South San Francisco, CA
03.2019 - 08.2020
Director, Clinical Operations
Adverum Biotechnologies
Menlo Park, CA
10.2017 - 01.2019
- Accountable for clinical program execution: vendor oversight, resource planning, timeline/budget management, and compliance.
- Provided operational leadership to translate program strategy into executable plans and lifecycle delivery, ensuring alignment with organizational goals.
- Collaborated on protocol and clinical document development, facilitating IND submissions and achieving expedited designations/briefing packages.
- Led study teams, coaching talent to enhance skills and managing performance to meet project milestones.
- Partnered with Quality to refine SOPs, mitigate compliance risks, and conduct vendor audits.
Director, Clinical Operations
Iovance Biotherapeutics, Inc
San Carlos, CA
09.2016 - 10.2017
- Led operational planning and execution for oncology program, ensuring adherence to timeline, budget, and quality standards.
- Negotiated and managed CROs/vendors, enhancing investigator engagement and site performance.
- Chaired cross-functional study forums, managing risks and issues to resolution.
- Drove process and SOP improvements across the department.
- Authored core study documents (protocol, ICF, monitoring/data plans) and governed change control.
Associate Director, Clinical Operations
Pharmacyclics LLC (An AbbVie Co.)
Sunnyvale, CA
07.2015 - 09.2016
- Program lead for a late-stage oncology portfolio; accountable for planning, resources, milestones, fiscal management, and compliant execution.
- Managed and developed team of 7, directing CTLs and study staff to ensure project alignment and compliance.
- Partnered with project management, clinical science, research, and supply to strategize and mitigate risks across programs.
- Established training priorities with Therapeutic ED to ensure role-based, GCP-aligned competency.
- Conducted sponsor oversight of CROs/vendors; participated in audits and inspections.
- Led department initiatives to modernize processes and tools.
- Directed study management for multiple trials, including a pivotal Phase 1b/2 CLL study culminating in accelerated FDA approval.
- Managed delivery from start-up through close-out; served as primary escalation point for sites and vendors.
- Developed study and vendor specifications (protocol, ICF, CRFs, monitoring plans, EDC/IRT) and supported CSR and NDA deliverables.
- Executed internal audits, mock inspections, and remediation plans to enhance inspection readiness and maintain TMF quality.
- Served as subject matter expert during FDA inspection.
Sr. Clinical Research Associate
Nektar Therapeutics, Inc.
San Francisco, CA
07.2009 - 11.2011
- Led Phase II oncology trials, ensuring adherence to regulatory standards and timelines.
Clinical Research Associate
Abbott Vascular
Santa Clara, CA
11.2008 - 07.2009
Clinical Research Associate
Conceptus, Inc.
Mountain View, CA
10.2007 - 11.2008
Clinical Research Associate
Protrials Research, Inc.
Mountain View, CA
09.2004 - 08.2007
Education
Bachelor of Science - Nutrition Science
University of California Davis
Davis, CA01.2001
Skills
- Global clinical trial management
- Risk management
- Process optimization
- Oncology knowledge
- Budgeting and forecasting
- Cross-functional leadership
- Program strategy development
- Regulatory compliance (GCP/ICH)
Timeline
Executive Director, Clinical Operations
Trishula Therapeutics, Inc
03.2023 - Current
Sr. Director, Clinical Operations
Trishula Therapeutics, Inc
08.2020 - 03.2023
Director, Clinical Operations
Tizona Therapeutics, Inc
03.2019 - 08.2020
Director, Clinical Operations
Adverum Biotechnologies
10.2017 - 01.2019
Director, Clinical Operations
Iovance Biotherapeutics, Inc
09.2016 - 10.2017
Associate Director, Clinical Operations
Pharmacyclics LLC (An AbbVie Co.)
07.2015 - 09.2016
Sr. Clinical Research Associate
Nektar Therapeutics, Inc.
07.2009 - 11.2011
Clinical Research Associate
Abbott Vascular
11.2008 - 07.2009
Clinical Research Associate
Conceptus, Inc.
10.2007 - 11.2008
Clinical Research Associate
Protrials Research, Inc.
09.2004 - 08.2007
Bachelor of Science - Nutrition Science
University of California Davis