Clinical Trial Research

Tonny Liu, Ph.D., MBA, PMP

Malden, MA, USA

Email: *******@*****.***

M: 781-***-****

PROFESSIONAL SUMMARY

• Certified as Clinical Research Ethical & Regulatory specialist, NIH launched;

• Outstanding Scientist in Clinical Oncology, Gynecological Cancer, mucosal immunology, cardiovascular disease, experienced with tumor biology models, immune-oncology related mice models, and molecular mechanism, Cancer Biomarker discovery through high-through genetic profile analysis, such as analyzed by using activity based proteomic profile, whole transcriptome microarray, protein antibody array and microRNA array, ABPP, NGS data analysis, etc;

• Project lead for key study and regulatory documents contribution (protocol, ICF, study manuals, briefing books); Lead internal meetings to review topics and develop mitigation plans, Partner with the medical director on oversight of clinical trial activities, including safety reviews and site monitoring, inspection readiness or leading and conducting clinical site, vendor/CRO, and internal process audits according to GCP guidance and regulations;

• Expertise in Clinical Trial management Systems such as CTMS (Clinical Trial Management System), eTMF

(electronic Trial Master file);

• Contribute to the development of presentations, abstracts, and publications emerging from clinical studies, ensure compliance of all activities with ICH/GCP guidelines, applicable regulatory requirements, and SOPs;

• Excellent project leader with PMP/Agile CSM certificate, professional in business /Financial analysis, Project management and team leadership, and experienced Competitive Intelligence consultant

• Excellent team leader and coach with advanced business mentorship skills;

• Expertise with business analytic software Palisade and Tableau software;

• Certificated Global Innovative Consultant (level 1&2);

• Certificated Strategic Management Consultant (level 1&2);

• Advanced proficiency with MS Office (Word, Excel, Outlook, PowerPoint, etc.); EDUCATION

Hult International Business School, Boston, MA

Master of Business Administration (MBA) 2016

Outstanding Scholarship Award for MBA program

University of Chinese Academy of Sciences, Beijing, China PhD, Biochemistry & Molecular Biology 2008

Dean’s List Excellent Graduate

Certificates:

MBTN market data analytics HubSpot inbound marketing Management Consulting Institute (MCI) Certificate Level 1/2, 2016 PMI- Certified Project Management Professional (PMP), 2013 Scrum Master (CSM) with Agile Project Management, 2014 PROFESSIONAL EXPERIENCE

Senior Clinical Project Manager, Clinical Trial Lead Hengenix Biotech, Inc. Aug 2022 ~ Now

• Successfully executed a Phase 3 ophthalmology trial and a Phase 2 oncology trial as lead;

• Developed clinical study project delivery strategy, including meticulous planning, execution, and management to ensure the study is conducted efficiently, within budget, and in compliance with all regulations.

• Coached and mentored clinical operation team, clinical trial managers and CRAs;

• Negotiated budgets and contracts, recruited clinical sites;

• Worked with Regulatory Affairs, Legal, Quality Assurance, and Finance teams to ensure alignment on outsourcing strategies and project budget;

• Managed clinical trial CROs and vendors, ensuring seamless patients’ samples & kits delivery of trial;

• Designed and implemented patient recruitment strategies and communication plans; development, review and implementation of departmental SOPs and processes, including development and/or review of templates, tools, and training materials.

• Managed Clinical Systems Veeva CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file);

• Managed Clinical trial projects budget financial planning, forecasting, contract negotiation;

• Proficient in relevant software such as IVRS/IWRS, Excel, and MS Project, and adept in overseeing scenario planning, clinical supply recommendations, and risk mitigation through comprehensive insight into supply and demand issues for high stakes and resource constrained programs.

• Planed and conduct of study committee meetings (e.g. IDSMC), investigator meetings, and advisory boards, including contribution to presentations and minutes;

• Preparate final reports of clinical trial data for study documents (including CSRs, IBs and DSURs);

• Utilized different data sources, such as electronic health records (EHRs), claims data or patient registries that can be utilized for conducting US RWE studies to support drug launches and patient’s recruitment. Senior Project Manager, Clinical Operation

Moderna. Inc. Dec 2021 ~ Jul 2022

• Involved in the Covid-19 vaccine Phase 3 US trial and fully been approved.

• Lead the Clinical Trial Operation team and support all related activities.

• Monitored study documentation and Sponsor Oversight of outsourced clinical activities

• Communicated study-status, cost, and issues to ensure timely decision making by senior management leadership

• Managed clinical projects timelines, including communication to internal and external team members on deliverables

• Managed trial feasibility process and oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team;

• Managed and maintained Clinical Systems Veeva CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file)

Project manager, Competitive Intelligence & strategy consulting Bioeagle Lab, LLC May 2020 ~ Nov 2021

• Managed systems changes, updates/creates documentation, and provided training for Scientific Partnership, legal/regulatory, and other stakeholders

• Responsible for tracking the activities of the overall market, specific competitors and providing activity updates, threat and opportunity assessments.

• Supports the development of new plans, programs, processes or products through findings and fact-based interpretations of competitive intelligence with a subject matter focus on competitive intelligence related to price, product and underwriting.

• Digital interactives for scientific congresses, mechanism of disease and clinical trial progress.

• Strategic & Management competitive intelligence consulting; data & Business analysis; Financial prediction & Planning;

• Responsible for coordinating, maintaining, leading, and managing projects and processes

• Responsible for providing medium to high complexity analytical and competitive research

• Identified and communicate trends, competitive forces, competitor strategies Senior Project Manager, Clinical Trial Manager, Operation Consultant Novartis Pharmaceutical Corporation, NY Sep 2018–May 2020

• Managed global Clinical Trial projects budget planning, monitoring, forecasting and financial prediction;

• Managed 20 drug clinical trial projects, each project budget over $10M

• Developed and managed clinical trial project financial management plan, tracking and monitoring the critical paths and key progresses

• Lead the identification, evaluation, and selection of external vendors, including CROs, central labs, and other clinical service providers.

• Oversee the development, negotiation, and execution of contracts, master service agreements (MSAs), work orders, and budgets.

• Clinical trial projects financial planning, forecasting, and competition intelligence with data analysis;

• Managed Clinical Systems Veeva CTMS, eTMF;

• Managed and communicated with clinical trial CRO companies, trial hospitals physician

• Lead the Clinical Trial Team to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures.

• Account for investigators meeting organization and internal meetings related to the clinical trial execution. In collaboration with the GDD or Sponsor Medical representative, lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation

• Provided clinical outsourcing specifications to facilitate selection of vendors.

• Account for project / trial allocation plans within given indications. Work closely with the Regional Monitoring Managers on feasibility and patient enrolment.

• Work with GBS Line Functions and QA to identify potential quality issues and implement actions to resolve them.

• Account for the development, management and tracking of trial budget working closely with the GBS Finance and Sponsor representative.

• Account for accuracy of trial information in all trial databases and tracking systems.

• Project managed experience in real- world evidence (RWE) studies, specifically related to examining treatment patterns, genomic sequencing and other analyses in the cancers therapeutic area. Senior Scientist, Project Lead

Glinda Bioscience, LLC Jan 2017 – Jul 2018

• Managed a Circulation Tumor Cells (CTC) capture based Start- up biotechnology & diagnostic platform, offered the novel clinical cancer diagnostics solution based on the microfluidic technology.

• Balanced potential risks and challenges, develop contingency plans, and effectively managed project and team

• Managed Scientific project collaboration with multiple partners.

• Lead diagnostic projects involving gene sequencing, from conception to completion, and ensuring to meet project objectives within timelines and budget constraints; Postdoctoral Research Fellow

Brigham & Women’s Hospital, Harvard Medical School, Boston, MA Oct 2010 – Sep 2015

• Developed and designed the plan of strategies, implementation, and execution for clinical cancer biomarkers discovery projects, integrated with multiple novel high through screen methods, including activity based proteomic profile, microarray, antibody array, etc.

• Screened cancer stem cells-like drug resistance target for Ovarian cancer;

• Explored the regulatory mechanism of infant mucosal immunology system development under DAMP & PAMP and gastric inflammation related diseases, including inflammation bowel disease;

• Collaborated with biomarkers diagnostic companies for developing novel cancer diagnostic device prototypes, analyzed and validated cutting-edge pilot translational research projects;

• Published research results at top rank research journals as Gut, PNAS, Clinical cancer research, etc.

Contact this candidate