Clinical Development Operations Leader (GxP)
Resume:
Isabel Luther
Vice President, Clinical Development Operations
**********@*****.*** 415-***-**** linkedin.com/in/biotechbay Executive Summary
Global Clinical Development Operations executive with 20+ years of leadership experience across biotechnology, biopharmaceutical, and CRO organizations. Trusted partner to executive leadership teams, boards, investors, and development stakeholders in advancing innovative oncology and immuno-oncology programs. Recognized for building high- performing organizations, enabling operational excellence, and leading teams through growth, transformation, and strategic milestones.
Selected Career Highlights
Built Clinical Operations function from first hire to scalable development organization.
Supported collaboration activities for a Gilead partnership valued up to $1.75B.
Enabled two IND clearances and rapid first-in-human study initiation.
Managed approximately $60M development portfolio budget.
Led and developed multidisciplinary teams across Clinical Operations, Safety, Data Management, Regulatory Affairs, and related functions.
Implemented validated 21 CFR Part 11-compliant systems and governance frameworks. Core Capabilities
Global Clinical Development & Operations Leadership
Oncology & Immuno-Oncology Development
First-in-Human Through Registrational Studies
Phase I-III Clinical Trials
IND, CTA & Regulatory Submission Support
Global Study Start-Up & Site Activation
CRO Governance & Vendor Management
Risk-Based Monitoring (RBM)
GCP, ICH E6(R3) & Audit Readiness
Health Authority Interactions
Clinical Systems (CTMS, eTMF, EDC, IRT, eCOA)
Portfolio Strategy & Governance
Budget Management & Resource Planning
M&A Due Diligence & Integration
Executive & Board Presentations
Operating Model Design & Talent Development
Strategic Partnerships & Alliance Management
Digital Transformation & AI Enablement
Isabel Luther
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Professional Experience
Career Break – Primary Caregiver Apr 2024 – Present
Continued professional development focused on evolving clinical trial regulations and ICH E6(R3) expectations, clinical trial technologies (AI governance and AI-enabled clinical operations) while prioritizing end-of-life and aging-in-place family caregiving responsibilities.
Pionyr Immunotherapeutics, Inc. (Ikena Oncology) – Vice President / Executive Director / Sr. Director, Head of Clinical Operations Jun 2019 – Mar 2024
Recruited as the company’s first clinical hire and built Clinical Operations into a scalable development organization supporting corporate growth from early-stage biotech through acquisition.
Led the organization through rapid expansion, pandemic-era disruptions, strategic partnerships, and acquisition-related transition activities.
Supported due diligence and development activities contributing to a Gilead Sciences collaboration valued at up to $1.75B, including a $275M upfront payment.
Enabled two IND clearances within approximately three months and rapid initiation of first-in-human oncology studies.
Owned approximately $60M portfolio budget and long-range operational planning supporting development objectives and cash runway management.
Secured executive endorsement for innovative sourcing strategies that reduced projected combination therapy supply costs by more than 20 percent.
Established enterprise outsourcing and CRO governance frameworks that provided transparency, accountability, and cross-functional alignment.
Led implementation of validated 21 CFR Part 11-compliant systems supporting document management, e-signature, and lifecycle management.
Built and developed high-performing teams, including individual contributors, managers, and senior leaders across Clinical Operations and related development functions.
Directed up to 15 professionals spanning Clinical Operations, Drug Safety, Medical Monitoring, Data Management, Biostatistics, Clinical Systems, Regulatory Affairs, Translational Operations, and Clinical Quality.
Biotech Bay Consulting – Senior Clinical Operations Consultant Nov 2016 – May 2019
Provided VP-level and senior clinical operations leadership to oncology and dermatology biotechnology companies.
Supported IND preparation, first-in-human execution, operational readiness, and GCP capability development.
Maintained continuity and performance for active oncology development programs during leadership transitions.
Isabel Luther
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Gilead Sciences – Senior Clinical Program Manager / Consultant Nov 2012 – Oct 2016
Led oncology clinical programs across multiple assets and Phase I/II studies within a global matrix organization.
Managed distributed teams across multiple geographical sites.
Identified outsourced service deficiencies and secured a $500,000 CRO credit while improving vendor oversight processes enterprise-wide. Onyx Pharmaceuticals – Associate Director, Clinical Operations Jan 2012 – Oct 2012
Led startup and launch activities for a global registrational multiple myeloma program across 25 countries supporting on-time patient recruitment milestones. Biotech Bay Consulting – Clinical Operations Consultant Sep 2010 – Dec 2011
Led Phase II oncology programs with emphasis on execution, clinical analytics, data quality, cleaning, and database lock readiness.
Medivation – Senior Clinical Project Manager Jan 2010 – Aug 2010
Established and activated an 18-country Phase III registrational oncology study team within seven months of hire, coordinating global regulatory and study-start-up strategy across FDA, MHRA, EMA, PMDA regions.
Earlier Career
Progressive clinical research and leadership roles with Cell Genesys, Immune Tolerance Network, Titan Pharmaceuticals, Sugen/Pfizer, PPD, Covance, and PRA.
Experience includes CRA management, site management, multinational trial execution, enrollment strategies, monitoring leadership, records remediation, biosample disposition, operational scale-up, large-scale trial closeout and successful strategic exit. Education & Certifications
B.A., Psychology – University of California, Berkeley Cancer Immunotherapy Winter School (SITC)
Project Management Certificate Program (PERI)
Certified Clinical Research Associate (ACRP)
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