RESUME

Ignacio Lauder, Jr. MD CCRP CHC

Vallejo, CA 94591

Email: ad0uy0@r.postjobfree.com

US Citizen

SUMMARY of EXPERIENCE:

● Experience clinical trials in Phases I-IV-for over 30-year experience in Infectious Disease, Cardiovascular Anesthesiology, Oncology/Hematology, Clinical Pathology including solid tumors such as Breast, Prostate, Esophageal, Gastric, Lung (NSCL/SCL), Genitourinary, Sarcomas, Melanomas, Lymphomas, Leukemias and therapeutic modalities such as immunotherapy and Chemotherapy;

•Extensive experience in the management and assessment of adverse events and serious adverse events as per FDA, EU, and CE guidelines

•In-Vitro Diagnostics Research and Development for 8 years

•Clinical trials in Neurosurgery, Neurology, and Neurosurgical device for over three years including stroke and brain injury

•Familiar with FDA, EU, and CE requirements including IND, NDA, RUO, 510K, PMA

•CTMS platforms, eCRF, EMR systems, Castor EDC, Medidata, Rave Medidata, Veeva

•Global Corporate Ethics and Compliance in the life science industry

•Global Sunshine Transparency Reporting Requirements

•Experienced in various compliance platforms including Medispend, Navex, Polaris EDUCATION:

Virgen Milagrosa University Foundation

Pangasinan, Philippines Doctor of Medicine, 1988

University of California, San Francisco, CA

Post-Graduate Clinical Research Design Course, 1993 Attended Project Management Course UC Berkeley Extension, 2013 Attended Principles of Compliance and Quality Management UC Berkeley Extension, 2015

Attended Healthcare Compliance Certification Program Seton Hall Law School, 2018

Continuing Regulatory, Clinical Research, and Medical Education through SOCRA, Medscape, and other online courses

PROFESSIONAL EXPERIENCE:

Clinical Trial Manager - Contractor

Intune Bio

June 2023 to present.

• Responsible for the overall development and implementation of the clinical study. Responsibilities may include such things as:

o Plan, coordinate, and execute clinical studies.

o Protocol development

o Oversees the progress of the study.

o Managing clinical trials costs and budgets

o Managing clinical research associates, vendors, and contracts o Develop final clinical study report.

• Develops processes and tools for all aspects of clinical study management.

• Manages CROs, Ssubcontractors, vendors, and internal personnel in the execution of clinical projects.

• Clinical Trial Data Management in assuring site and sponsor compliance with regulatory obligations and requirements in accordance with GCP guidelines

• Mentor and provide leadership to the clinical and regulatory affairs organization to ensure accountability and support the efficient achievement of clinical trials. Clinical Trial Manager/Clinical Affairs

Lucira Health, Emeryville, CA

May 2022 to Feb 2023

• Responsible for the overall development and implementation of the clinical study. Responsibilities may include:

o Oversees the progress of the study.

o Study protocol development

o Managing clinical trials costs and budgets

o Managing clinical research associates, vendors, and contracts o Develop final clinical study report.

• Develops processes and tools for all aspects of clinical study management.

• Manages subcontractors, vendors, and internal personnel in the execution of clinical projects.

• Clinical Trial Data Management in assuring site and sponsor compliance with regulatory obligations and requirements in accordance with GCP guidelines

• Mentor and provide leadership to the clinical and regulatory affairs organization to ensure accountability and support the efficient achievement of clinical trials. Part-Time Consultant GLG Consulting September 2021 to April 2022

● Consultant in Healthcare Compliance and Clinical Research Management Clinical Affairs / Healthcare Compliance Specialist / Business Ethics Manager - Bio-Rad Laboratories, Inc., Hercules, CA October 2015 to March 2021

● Implement global corporate compliance relating to the development, manufacturing, and distribution of broad range of products for life science research and clinical diagnostic markets.

● Implement and communicate processes that support adherence to the corporate anti- corruption act, foreign corrupt practices act, false claims act, and sunshine act transparency policies.

● Develop several draft agreement templates with the legal team for an efficient and timely manner of business transactions.

● Experienced in developing new In-Vitro Diagnostics (IVD) medical devices including new biomarkers for diagnostic and/or monitoring assays.

● Serve as the primary compliance advisor to management and local marketing director on a wide range of business and compliance matters related to the organization’s business, including strategic initiatives, interpretation of relevant laws and regulatory issues.

● Review business courtesies requests including research collaboration for accuracy and completeness (against company policy) and coordinate with the local management team to ensure requests move through the approval process in an effective and timely manner.

● Develop policies, standard operation procedures, and documentation for various business processes and initiatives including research and development, clinical trials, and marketing.

●Verify and validate all transactional data required for federal and state transparency reporting including quarterly certifications

● Identify and recommend system and process changes necessary for the accurate collection of data and increase efficiency among sales, marketing, and administrative teams.

●Facilitate a culture of compliance across the organization toward achieving a high level of compliance on company policies and regulations

● Clinical Affairs role includes external collaborations in the development of IVD products.

●Support clinical trial management in the development of clinical trial protocols as well as creating clinical trial templates. Additionally, he is primarily responsible for managing the sample procurement for tissue and blood specimens including companion diagnostics protocols.

Clinical Research Consultant

Jun Lauder, LLC

November 2014 – October 2015

Clinical trial audits at investigator sites and IRBs including regulatory compliance as per FDA and OHRP regulations.

• Perform Clinical trial audits at investigator sites and IRBs including regulatory compliance as per FDA, GCP ICH, and IRB regulations.

• Develops synopsis, and protocols, and creates CRF/eCRF at CTMS platforms.

•Develop electronic data capture systems and create reports of clinical data.

• Leads clinical data management activities by using clinical knowledge, data listings, and manual review of eCRFs to issue queries and clean data as required.

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• Contributes to the monitoring of data quality during clinical trial operations and provides findings after an audit on issues along with proposed resolutions.

• Verification of data in EDC is consistent with medical records including electronic medical records.

• Ensure that clinical procedures are consistent with a clinical trial protocol including laboratory and diagnostic procedure.

• Ensure that all adverse events including serious adverse events are reported to FDA and IRB as well as captured in EDC.

• Ensure compliance with FDA, GCP and IRB regulations.

• Develop and maintain written procedures for conduct of clinical trials in accordance with FDA and other international government regulations.

• Ensure that database management is consistent, and that data integrity is maintained.

• Ensure that the appropriate statistical analyses are consistent with each study design to demonstrate all safety and effectiveness claims.

Primary Clinical Research Coordinator University of California, San Francisco San Francisco General Hospital

October 2011 to October 2014

• Implement clinical research protocols in the clinics particularly in the field of Neurosurgery, Neurovascular and Neurocritical disciplines.

• Ensure compliance with FDA, GCP, IRB and other regulatory agency guidelines and regulations for clinical investigations.

• Supervise the Clinical Monitors and their activities.

• Develop and maintain written procedures for the conduct of clinical trials in accordance with FDA and other international government regulations.

• Coordinated the administrative and budgeting activities for clinical trials.

•Ensure outcomes data collected as per Good Clinical Practices and HIPAA regulations

• Ensure that results of clinical statistical analyses are reported in a manner consistent with FDA and other regulatory requirements.

• Ensure that database management is consistent, and that data integrity is maintained.

• Ensure that the appropriate statistical analyses are consistent with each study design to demonstrate all safety and effectiveness claims.

CLINICAL RESEARCH CONSULTANT

JUN LAUDER, LLC

On assignment with the UC Davis/VA Northern California Health Care System and Contra Costa Regional Medical Center

July 2007 to October 2011

• Implement clinical research protocols in the clinics particularly in the field of Hematology, Oncology, and Infectious Disease

• Management of research activities of several medical centers in San Francisco Bay Area including physicians, pharmacists, nurses, residents, and fellows in the implementation of clinical research protocol

• Provide quality assurance consultation to medical institutions and regulatory agencies to ensure program compliance and enhancement related to FDA, GCP, ICH, and IRB guidelines.

•Coordinate studies within a large oncology network of university and hospital-based sites

• Train and Manage CRAs, Nurses, and Pharmacist in implementing the clinical trial protocol. UC-DAVIS/VA NORTHERN CALIFORNIA HEALTH CARE SYSTEM Clinical Research Manager/Coordinator

April 1994 to June 2007

• Implement clinical research protocols in phase I - IV in the field of Hematology, Oncology, Rheumatology, and Infectious Disease

• Assure compliance with FDA, GCP, IRB and other regulatory agency guidelines and regulations for Clinical investigations.

• Supervise the Clinical Monitors and their activities.

• Management in the development of synopsis and protocols and other documents for all phase I – IV clinical studies

• Develop and maintain written procedures for conduct of clinical trials in accordance with FDA and other international government regulations.

• Coordinate the administration and budgeting for clinical trials.

• Ensure outcomes data collected per Good Clinical Practices and HIPAA regulations.

•Assure that results of clinical statistical analyses are reported in a manner consistent with FDA and other regulatory requirements

• Assure that database management is consistent, and that data integrity is maintained.

• Assure that the appropriate statistical analyses are consistent with each study design to demonstrate all safety and effectiveness claims.

• Train and Manage CRAs, Nurses and Pharmacist in implementing the clinical trial protocols. UC-SF/VAMC AND KAISER-PERMANENTE MEDICAL CENTER, DEPARTMENT OF CARDIOVASCULAR ANESTHESIA,

San Francisco, California

October 1990 to April1994

• Implement clinical research protocols in phase I - IV, particularly in the field of Cardiovascular Anesthesiology

•Assure compliance with FDA, GCP, IRB and other regulatory agency guidelines and regulations for Clinical investigations

• Supervise the Clinical Monitors and their activities.

• Assist in the development and review of protocols and other documents for all clinical studies.

• Utilize clinical educational opportunities to maintain medical knowledge relative to the studies being performed.

• Develop and maintain written procedures for the conduct of clinical trials in accordance with FDA and other international government regulations.

•Assure that all clinical studies follow departmental SOPs

• Responsible for coordinating the administrative and budgeting activities for clinical trials.

• Ensure outcomes data collected per Good Clinical Practices and HIPAA regulations.

•Responsible for supervising and directing activities of the Biostatistician and all statistical services

•Assure that results of clinical statistical analyses are reported in a manner consistent with FDA and other regulatory requirements

• Assure that database management is consistent, and that data integrity is maintained.

• Assure that the appropriate statistical analyses are consistent with each study design to demonstrate all safety and effectiveness claims.

• Train and Manage CRAs, Nurses, and Pharmacist in implementing the clinical trial protocols. ARMED FORCES OF THE PHILIPPINES MEDICAL CENTER,

Post-Graduate Medical Intern

Manila, Philippines

May 1988 to April 1989

12-month clinical rotation internship in all clinical disciplines including Internal Medicine, Neurosurgery, Orthopedic Surgery, Urology, Oncology, Radiology, Obstetrics, Gynecology, Pediatrics, Pathology

COMPUTER SKILLS:

● CTMS Applications such Medidata, Rave, IBM solutions, etc.

● EDC Applications such as Castor EDC, etc.

Familiar with Aruvio and Salesforce Software (Third Party/Channel Partner Policy)

● MS Office (Word, Excel, Outlook, PowerPoint)

● Adobe Acrobat

● Google Apps

● EDC Applications such as Castor EDC, etc.

● Familiar with Business Courtesies Portal (NAVEX/Medispend Compliance Portal)

● Familiar with the Fair Market Value (InteractRx) CERTIFICATIONS:

● Certified Healthcare Compliance, 2018

● Certified Clinical Research Professional (SOCRA 2007) LICENSURES:

● Physician Medical License No. 0069910, Issued in January 1990 MEMBERSHIPS:

● Member, Philippine Medical Association

● Member, Southwest Oncology Group (SWOG-USA)

● Member, American Cancer Society

● Member, Northern California Oncology Group

● Member, California Cancer Consortium

● Member, Society of Clinical Research Associates (SOCRA) HIGHLIGHTS:

● Extensive experience in managing clinical trials for both industry and governmental-funded studies as per FDA, ICH and GCP guidelines including management and assessment of serious adverse reporting requirements as per FDA, EU, and CE

● Experienced in developing new In-Vitro Diagnostics (IVD) medical devices including new biomarkers for diagnostic and/or monitoring assays.

● Extensive experience in clinical trial phases I-IV in various clinical Disciplines such as neurosurgery, neurovascular, neurology, oncology, hematology, infectious, and cardiology.

● Global corporate compliance specialist relating to the development, manufacturing, and distribution of a broad range of products for life science research and clinical diagnostics market.

● Implementation and adherence to the corporate anti- corruption act, foreign corrupt practices act, false claims act, sunshine transparency reporting requirements, General Data Protection Regulation, Conflict of Interest, and other legal and compliance matters.

PUBLICATIONS:

Upon Request

REFERENCES:

Upon Request

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