Clinical Research Professional · Wister Group LLC

Jean
Mastrangelo

MSHS — Sr. Director, Clinical Operations | Pharmaceutical & Biotechnology

Transformational Clinical Operations executive with 20+ years building, scaling, and leading global clinical development organizations across oncology, CNS, rare disease, and cardiometabolic indications. Proven track record delivering 5 NDA approvals through disciplined operational governance, enterprise risk management, and cross-functional executive leadership. Trusted strategic partner to C-suite, Boards, and global regulatory agencies.

Phase I–III Trials Global Clinical Operations CRO Management IND · NDA · BLA CAR-T · Oncology CNS · Neurology First-in-Human Studies GCP Compliance

20+

Years Experience

NDA Approvals

I–III

All Clinical Phases

$75M+

Budgets Overseen

Core Expertise

What Jean Delivers

Clinical Program Management

End-to-end operational leadership for global Phase I–III trials — from protocol design through regulatory submission. Proven in managing multi-cohort dose-escalation oncology studies, including FIH monoclonal antibody programs and CAR-T cell therapy trials.

CRO & Vendor Management

Primary accountability for CRO selection, RFP development, contract negotiation, and governance framework establishment. Extensive experience managing Australia-based and global CRO partners across leading oncology networks aligned with TGA, ICH-GCP E6(R2), and FDA requirements.

Regulatory Strategy & Submissions

Deep experience with FDA and international regulatory agencies on IND, NDA, and BLA submissions. Served as a key contributor on the LY03004 NDA team leading to successful approval for Schizophrenia treatment. Expertise in TGA pathway navigation and Australian clinical trial strategy.

Biotech Startup Operations

Specialized expertise in building clinical operations infrastructure from the ground up for early-stage biotech companies. Established U.S.-based offices and clinical operations teams, developed SOPs, and created the processes and structures that enable small teams to execute like large organizations.

First-in-Human Trial Execution

Directed the operational execution of complex FIH Phase 1 SAD/MAD studies. Managed Safety/Cohort Review Committee (S/CRC) meetings, implemented adaptive design protocols (3+3 and BOIN methodologies), and oversaw real-time cohort progression including sentinel dosing.

GCP Compliance & Quality

Maintained rigorous compliance with ICH, GCP, and all applicable regulatory requirements across global trials. Led SOP development and quality assurance initiatives, established department processes, and served as the single point of accountability for clinical operations integrity.

Therapeutic Focus

Areas of Specialization

Jean has accumulated rare breadth across therapeutic areas — spanning neurology, oncology, cardiovascular, rare disease, and pediatric conditions. This cross-therapeutic experience enables her to advise on development strategy, trial design, and operational execution with genuine scientific and clinical depth.

Her international trial experience spans the US, Europe, Australia, South America, Japan, and China — providing the global operational fluency that early-stage biotech companies need as they expand beyond domestic development.

Oncology CAR-T Cell Therapy CNS / Neurology Cardiovascular Parkinson's Disease Schizophrenia Major Depression Pediatrics Epilepsy Rare Disease Biologics / Vaccines Immuno-Oncology Precision Medicine Cell-Based Therapy

Ph I

Phase I — First-in-Human & Dose Escalation SAD/MAD studies, FIH monoclonal antibody programs, dose-limiting toxicity evaluation, Safety Review Committee coordination, MTD/RP2D determination using adaptive design (3+3, BOIN)

Ph II

Phase II — Proof of Concept & Expansion Global Phase II oncology and CNS trials, patient enrollment strategy, cross-functional team leadership, site performance management across US, Europe, and Asia-Pacific

Ph III

Phase III — Pivotal & Registration Trials Pivotal trial execution, NDA submission support, regulatory agency interactions, budget management, CRO oversight, and cross-functional integration through to submission and approval

IND

IND Filing & Regulatory Strategy Full IND support for Ex-US startup clients entering US development, TGA pathway navigation for Australian programs, FDA and international health authority meeting preparation

Selected Experience

Organizations Served

Jean's 20+ year career spans global pharmaceutical companies, specialty biotech, and early-stage startups across oncology, CNS, rare disease, cardiovascular, and pediatric indications. She has built clinical operations teams from the ground up, led Phase I–III trials across the US, Europe, Asia-Pacific, and South America, contributed to 5 NDA approvals, and served as a trusted strategic partner to C-suite executives and founders navigating complex development programs.

DynamiCure Biotechnology
Karuna Therapeutics
Klus Pharma
Luye Pharma Group
Tmunity Therapeutics
Marinus Pharmaceuticals
Inovio Pharmaceuticals
Clinlogix LLC
BTG International

Education

Academic Foundation

Trident University

Master of Science, Health Sciences — Clinical Research Administration

2009

Summa Cum Laude

Pennsylvania State University

Bachelor of Science, Business Administration

2000

Professional Certifications

Six Sigma · Drug Regulatory Affairs · Clinical Data Management · Healthcare Administration & Leadership

Ongoing Professional Development

Technology & Publications

Tools & Contributions

Jean brings deep fluency with the clinical technology stack used across pharmaceutical and biotech organizations — from project management platforms to EDC systems and regulatory databases.

MS Project Smartsheet SharePoint Medidata Medrio Veeva MS Office Suite EDC Systems CRM Platforms eCRF Development UAT Database Lock

Peer-Reviewed Publication

D. Wright, K. Gibson, J. Barclay, A. Razumovsky, J. Rush, C. McColum — High prevalence of right-to-left shunt in patients with symptomatic great saphenous incompetence and varicose veins. Society of Vascular Surgery, August 2009.