Summary
Overview
Work History
Education
Skills
Phone - Number
Training
Therapeutic Areas
Profileoverview
Languages
Certification
Websites
Timeline
Generic

Sharon Lariosa

Wilmette,IL

Summary

Results-oriented Executive Medical Director with 25 years of experience in clinical trials, focusing on oncology Phase I-III development. Proven expertise in problem-solving and patient safety, enhancing trial efficacy. Adept at building key opinion leader relationships and leveraging data-driven insights to consistently meet project milestones and contribute to advancements in medical science.

Overview

29
29
years of professional experience
1
1
Certification

Work History

Executive Medical Director

Kapadi
06.2022 - Current
  • Provide strategic medical and scientific leadership to executive management and project teams.
  • Provide overall medical and safety oversight.
  • Lead the Medical Monitoring (MM) team in performing MM activities, including the development of the Medical Monitoring Plan (MMP), and reviewing SAE reports.
  • Interact with inter-departmental and external consultants, key opinion leaders, and regulatory agencies as appropriate.
  • Participate in proposal development and project bid defense activities.
  • Maintained clinical and technical expertise in the therapeutic care of oncology.

Executive Medical Director

Shasqi
11.2021 - 03.2022
  • Lead the Medical Monitoring (MM) team in performing MM activities, including the development of the Medical Monitoring Plan (MMP), and reviewing SAE reports.
  • Medical point of contact for scientific issues, questions, and clarifications for internal and external stakeholders (e.g., IRB, sites).
  • Coordinated and authored protocol synopses, major protocol amendments, and communicated upcoming changes.
  • Assisted the CMO with the design and final recommendations in the clinical development plan for their drug(s), after soliciting appropriate input and review from colleagues within Regulatory Affairs, Commercial, Medical Affairs (Global and Regional), Manufacturing, Clinical Pharmacology, Statistics, Health Economics, Outcomes Research, and other line functions.
  • Lead the global medical team(s) to design, implement, and conduct multi-phase development studies globally to support the filing of successful regulatory submissions and supplemental filings post-approval.
  • Managed and mentored a specific therapeutic area/sub-group through the successful recruitment and retention of high-performing teams and individual contributors.
  • Responsible for managing the development and deployment of resources, while ensuring optimal oversight and supervision to ensure technical, leadership, and team membership skills are maintained.
  • If not directly managing other medical directors, serves as a mentor and works with senior line management to provide feedback and input to the career development of junior medical staff.

Executive Director, Clinical Scientist

Prelude Therapeutics
01.2021 - 10.2021
  • Interacted with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols.
  • Researched and assisted in the selection of investigators for clinical studies.
  • In collaboration with the clinical teams for a specific product candidate, I designed, prepared, and initiated study protocols and other required documentation in compliance with project plans, federal regulations, GCP, and good medical practice.
  • Conducted appropriate literature research for the assigned clinical product candidate.
  • Collaborated with clinical operations and other internal study team members to develop Informed Consent Forms, Case Report Forms, and CRF instructions.
  • Acted as the primary contact for the clinical study team for medical monitor inquiries, with guidance and oversight from the Program Director assigned to the clinical program.
  • Collaborated with clinical operations and other team members in the development of agendas, training materials, and presentations for site visits, investigator meetings, and other study-related venues.
  • Participated in internal safety meetings, analyses, and reports of potential safety events.
  • Collaborated with team members in the clinical review and interpretation of study data in support of the preparation of reports for health authorities, including regulatory filing documentation and study close-out reports.
  • Assisted in the writing and review of product-specific abstracts, publications, and supported the development of presentations for scientific meetings.
  • Proactively provided feedback on emerging clinical and competitive trends.
  • Demonstrated a thorough understanding of both clinical and commercial strategies and priorities.
  • Coordinated and facilitated oncology trials by developing and maintaining excellent working relationships with study investigators.
  • Delivered high-quality scientific presentations on Prelude’s investigational agents to physicians and other key external customers.
  • Provided clinical education support for internal Prelude customers.
  • Maintained clinical and technical expertise in the therapeutic care of oncology.

Sr. Medical Monitor

PRA Health Sciences
11.2019 - 01.2021
  • Lead the Medical Monitoring (MM) team in performing MM activities, including the development of the Medical Monitoring Plan (MMP) and the review of SAE reports.
  • Clinical point of contact for scientific issues, questions, and clarifications for internal and external stakeholders (e.g., IRB, sites).
  • Responsible for trial design and endpoint development in collaboration with the Clinical Director.
  • Set up and supported SAC, DMC, and adjudication committees.
  • Protocols/amendments – collaborates with the medical writer (MW), participates in the governance committee review.
  • Provided scientific input to the Study Manager (SM) for data management activities (e.g., EDC, DRP, CRFs).
  • Scientific Lead on the Clinical Trial Team (CTT)
  • Collaboratively planned CSRs, CTDs, and WMAs with medical writing.
  • Supported publications and presentations as needed.
  • Mentored other clinical scientists.

Senior Clinical Project Manager

Becton Dickinson
04.2019 - 11.2019
  • Worked without appreciable supervision and direction, prepared and/or reviewed study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Consent forms, Investigator Brochures, Medical Monitoring Plan, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines, and other relevant study plans and charters).
  • Collaborated with medical directors and supported pharmacovigilance regarding safety and medical issues.
  • Reviewed medical data as part of medical monitoring, including labs, patient profiles, CRF data, and eligibility, enrollment, and protocol deviations.
  • Conducted a medical data review and generated data queries in collaboration with data management.
  • Served as a Clinical Project Manager, ensuring that the Study Management team met and exceeded timelines and deliverables.
  • Mentored junior Clinical Project Managers.
  • Managed relationships with sites and PIs.
  • Other study-related vendors, including CROs,
  • Implemented intermediate knowledge of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost/material and human resource, quality, communication/escalation, risk, value), and organizes/facilitates meetings and discussions as needed.
  • Created aggressive, but achievable resource and budget forecasts, and timelines.
  • Interacted with both internal and external contacts, providing direction to the GCD cross-functional team members and vendors (if applicable) regarding the technical, protocol-specific, and operational aspects of assigned studies.
  • Proactively identified and managed risks and issues (including a log, mitigations, and contingencies) to ensure cost-effective, timely delivery of the project, including escalation if needed.

Senior Clinical Study Manager

Astellas
12.2016 - 03.2019
  • Managed and lead the day-to-day operations of assigned US and Global studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements
  • Managed and lead cross-functional study teams, including vendors
  • Responsible for accurate and up-to-date study information within CTMS and other relevant tracking systems and provided regular updates; proactively identified and resolved issues that occurred during study conduct; managed escalation of study-related issues
  • Reviewed medical data as part of medical monitoring including labs, patient profiles, CRF data and eligibility, enrollment, and protocol deviations
  • Chaired and presented investigator/KOL meetings in support of training and presenting study updates
  • Lead development of budgets and timelines for assigned studies
  • Ensured accurate forecasting, tracking, timely review, and escalation of variances within established processes
  • Lead the development of study plans and system set-ups; participated in preparation for and ensured operational excellence of protocol, CRF, CSR and other key study team documents
  • Participated in process improvement and quality-related initiatives associated with study execution and deliverables; participated in establishment of best-in-class processes and standards for study conduct
  • Responsible for the preparation and management of budgets, timelines, and resources for assigned clinical studies of up to $100M

Research Manager

Takeda
04.2015 - 07.2016
  • Managed all aspects of the US External Research program including Investigator Initiated and Sponsored Research (IISR) studies for multiple therapeutic areas and product programs
  • Managed TA and product level study budgets and communicate study activities to internal stakeholders
  • Oversight and managed the activities of USMA research project managers, including the initiation, tracking, completion, and reporting of studies
  • Responsible for the conduct of IISR studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external regional and country specific regulatory guidelines
  • Served as the US External Research therapeutic area lead for interfacing with internal stakeholders (e.g., GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc.) and external investigators to develop and execute USMA research plans and budgets
  • Chaired, presented, and assisted regions with the conduct of cross-functional TA research committee meetings used to review, approve, and track studies
  • Managed, directed, coached, and developed individual Project Managers as assigned

Lead Clinical Research Associate

Abbott
01.2011 - 04.2015
  • Lead manager on investigator-initiated clinical trials within Abbott’s internal specimen study collection program.
  • Responsible for the cross-functional development of the Medical and Scientific Affairs IIS (Investigator-Initiated Studies) process improvement program.
  • Assisted senior staff and interacted with R&D teams, the Statistical Support department, and Medical Affairs in planning the study and developing the study conduct.
  • Reviewed medical data as part of medical monitoring, including labs, patient profiles, CRF data, and eligibility, enrollment, and protocol deviations.
  • Functioned as Study Manager (as designated by projects), responsible for writing protocols, designing case report forms (CRFs), selecting and managing Contract Research Organizations (CROs), selecting and training investigator sites, planning and running study meetings, and evaluating, selecting, and training new study investigators to ensure compliance with protocol and ICH/GCP guidelines.
  • Ensured that all CRFs are complete, and queried the site as needed.
  • Participated in audit activities and responses.
  • Presented study progress reports to management.
  • Responsible for clinical research monitoring activities required for design validation studies, including specimen procurement, for in vitro diagnostic products.
  • Performed pre-study activities, including qualification monitoring visits to the site, and securing essential documents.
  • Conducted initiation, interim, and close-out monitoring visits.

Clinical Trials Manager

NorthShore University Health System
09.2007 - 09.2010
  • Managed NIH and pharmaceutically sponsored clinical research studies from start-up to close-out in the Department of Neurology.
  • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP, and ICH guidelines.
  • Assisted in patient recruitment.
  • Lead manager on investigator-initiated clinical trials within Abbott’s internal specimen study collection program.
  • Screened study patients, and coordinated all study activities as required by the study protocol.
  • Effectively maintained both study drug and device accountability, as well as documented and reported all AEs and SAEs to the sponsor and the IRB.
  • Functioned as a regulatory coordinator.
  • Ensured accurate data collection and entry to CRFs.
  • Managed research databases, and prepared reports as required.
  • Managed and tracked research funds.
  • I worked side by side with the ENH Research Institute regarding any research-related budget and contract activities.
  • Supervised and mentored graduate students, research assistants, and coordinators.
  • Developed, wrote, and managed investigator-initiated study protocols.

Clinical Research Manager

The Clinics of Rosalind Franklin
06.2006 - 09.2007
  • Managed NIH and pharmaceutically sponsored multidisciplinary clinical research studies from start-up to close-out.
  • Developed, wrote, and managed investigator-initiated study protocols
  • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP, and ICH guidelines.
  • Assisted in patient recruitment
  • Screened study patients, and coordinated all study activities as required by the study protocol.
  • Effectively maintained both study drug and device accountability, as well as documented and reported all AEs and SAEs to the sponsor and the IRB.
  • Functioned as a regulatory coordinator.
  • Ensured accurate data collection and entry to CRFs.
  • Managed research databases, and prepared reports as required.
  • Managed and tracked research funds
  • Worked side by side with the Office of Sponsored Research regarding any research-related budget activities.
  • Supervised and mentored graduate students, research assistants, and coordinators.
  • Presented lectures in clinical research to graduate students in the College of Biomedical Sciences.

Clinical Research Coordinator

Rush University Medical Center
09.2003 - 05.2006
  • Primarily responsible for managing numerous NIH- and pharmaceutically-sponsored clinical research studies from start-up to close-out in the Department of Medicine, Section of Rheumatology.
  • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP, and ICH guidelines.
  • Assisted in patient recruitment.
  • Screened study patients, and coordinated all study activities as required by the study protocol.
  • Effectively maintained both study drug and device accountability, as well as documented and reported all AEs and SAEs to the sponsor and the IRB.
  • Ensured accurate data collection and entry to CRFs.
  • Managed research databases, and prepared reports as required.
  • Functioned as clinical backup and a resource for both clinical and non-clinical staff.

Clinical Research Specialist

Access Medical Group
07.2003 - 08.2003
  • Provided clinical support to the project manager and the entire clinical research team for a contract research project through Kelly Scientific.
  • Recruited research sites, as well as coordinated with principal investigators and study coordinators.
  • Processed, reviewed, and entered CRFs in the research database.
  • Handled and resolved IRB issues.
  • Acted as a resource person for clinical issues pertaining to the study protocol and study medication, e.g., sample selection criteria, and adverse events.

Research Associate

Block Foundation for Clinical & Nutritional Cancer Research
01.2001 - 01.2003
  • Provided support to the Medical Director in the gathering and processing of scientific and medical data, which resulted in the formation of medical protocols in oncology and integrative medicine.
  • Managed numerous NIH- and pharmaceutically-sponsored clinical research studies, phases I-IV, including dose escalation studies from start-up to close-out.
  • Assisted the Clinical Research Manager in data collection, data entry, data quality review, manuscript preparation, and presentation of study results.
  • Acted as a liaison among the investigator, subjects, IRB, and clinical trial sponsor.
  • Assisted in the preparation of IRB documents and CRFs.
  • Developed, implemented, and managed the organization of scientific and medical files as part of the research database.
  • Coordinated with clinical staff regarding literature relevant to current medical protocols.
  • Supervised and delegated research assignments to rotating UIC PharmD interns.

ER Physician

Paranaque Medical Center
01.1998 - 01.2001
  • Attended to emergency room cases.
  • Diagnosed, managed, and referred complicated cases to consultants on duty.
  • Performed minor surgeries, e.g., wound suturing, circumcisions, IV-line placements, and normal deliveries, and assisted in major surgical and obstetrical cases.

Medical Externship

Makati Medical Center
01.1996 - 01.1997
  • I rotated in different specialty departments of medicine.
  • Diagnosed and managed cases under the supervision of a senior hospitalist.
  • Assisted in major surgeries, e.g., appendectomy and caesarean delivery.

Education

Master’s - Public Health

University of Illinois Chicago School of Public Health
01.2017

Emergency/Family Medicine -

Paranaque Medical Center
01.2001

Doctor of Medicine -

University of the East Ramon Magsaysay Medical Center
01.1995

Bachelor of Science - Public Health

University of The Philippines
Manila, Philippines
04-1990

Skills

  • Clinical Development
  • Medical Monitoring
  • Patient safety, safety assessments, pharmacovigilance
  • Data, healthcare analytics
  • Data analysis
  • Data-driven decision making
  • Patient-centric
  • Excellent communication skills
  • Good organizational skills
  • Excellent problem-solving skills
  • Attention to detail
  • Analytical thinking
  • Clinical research
  • KOL relationship building
  • Conflict resolution
  • Oncology Phase I-III: solid, hema-oncology, immunotherapy, CAR-T, vaccines

Phone - Number

847-312-8520

Training

  • Northwestern University, Overview of Clinical Trials Management
  • SOCRA, Course in Clinical Trials Management
  • WIRB, IRB Process and Ethical review of Clinical trials
  • CITI, ICH Good Clinical Practice E6 (R2),

Therapeutic Areas

Solid Tumors - Small and Non-small Lung Cancer, Breast, Sarcoma, 1, 2, Solid Tumors . Hema-onco Chronic Myelogenous Leukemia (CML),  Acute Myeloid Leukemia (AML),  Multiple Myeloma/Plasma Cell Neoplasm,  Polycythemia Vera. Metabolic & Cardio - Obesity, Type II Diabetes. Neurology - Epilepsy, Sleep Disorders. Psychiatry - Depression. Vaccines for Bacterial/Viral Disease Prevention. Rare Disorders. Device/Diagnostics: Cardiology, Oncology, Infectious, and Neurology.

Profileoverview

Provides strategic leadership, organization, and training of the medical operations group. Supports assurance on growth of revenue and profitability through the provision of quality, medical services for the company’s internal executive management, project teams and clients. Provides medical services which include but is not limited to medical, clinical, and scientific advisory expertise, overall medical and safety oversight during project delivery lifecycle and medical contribution to proposal development and business development activities. Assures compliance with (1) standard operating procedures, (2) FDA and ROW agency guidelines, legislation, and procedures, (3) all applicable national and international regulations, and (4) Company and client project plans and expectations.

Languages

English
Native/ Bilingual
Tagalog
Native/ Bilingual
Spanish
Limited

Certification

  • ASCO
  • ASH

Websites

Timeline

Executive Medical Director

Kapadi
06.2022 - Current

Executive Medical Director

Shasqi
11.2021 - 03.2022

Executive Director, Clinical Scientist

Prelude Therapeutics
01.2021 - 10.2021

Sr. Medical Monitor

PRA Health Sciences
11.2019 - 01.2021

Senior Clinical Project Manager

Becton Dickinson
04.2019 - 11.2019

Senior Clinical Study Manager

Astellas
12.2016 - 03.2019

Research Manager

Takeda
04.2015 - 07.2016

Lead Clinical Research Associate

Abbott
01.2011 - 04.2015

Clinical Trials Manager

NorthShore University Health System
09.2007 - 09.2010

Clinical Research Manager

The Clinics of Rosalind Franklin
06.2006 - 09.2007

Clinical Research Coordinator

Rush University Medical Center
09.2003 - 05.2006

Clinical Research Specialist

Access Medical Group
07.2003 - 08.2003

Research Associate

Block Foundation for Clinical & Nutritional Cancer Research
01.2001 - 01.2003

ER Physician

Paranaque Medical Center
01.1998 - 01.2001

Medical Externship

Makati Medical Center
01.1996 - 01.1997

Master’s - Public Health

University of Illinois Chicago School of Public Health

Emergency/Family Medicine -

Paranaque Medical Center

Doctor of Medicine -

University of the East Ramon Magsaysay Medical Center

Bachelor of Science - Public Health

University of The Philippines
Sharon Lariosa