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Amy Joan Muchinsky

** ********* ******

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

OBJECTIVES

Leadership opportunities that facilitate regulatory compliance across clinical and commercial teams during the development of products involving research on investigational and post-marketed products involving adult and pediatric populations. Work on innovative biotechnology, pharmaceutical and medical device products that prevent, heal and provide cures on a national and global level. Perform required and initiated responsibilities as a part of a dynamic team that inspires integrity, ethics, teamwork, individuality and a healthy work-life balance. SUMMARY OF QUALIFICATIONS

Over 25 Years of Combined Education

and Clinical Trial Experience (Full time,

Consulting, Part-Time, In-House and

Remote)

Clinical Regulatory Operations

Management

Senior Clinical Trials Regulatory

Compliance Specialist

Sponsor Driven Research under 21 CFR

part 312.53 and 312.56

Investigator Driven Research under 21

CFR part 312.53 and 312.66

Rapid-response Capability Trials

(CoVPN)

Leadership and Mentorship Programs

for Interns and Staff

Protocol Development

Internal and External Investigational

Review Board Submissions

FDA submissions; 510(k), IND, PMA,

PMN

Relevant CITI, DMID, EHSO, and NIH

certifications

Project Management

Data Management

Quality Assurance

Corporate and Academic work experience

Grant Preparations

Protocol Development

Case Report Form Development (CRF)

Manual of Operating Development (MOP)

Standard Operating Procedure

Development (SOP)

Therapeutic Areas of Infectious Disease,

Gastroenterology, Neurology,

Cardiology, Oncology, Immunology,

Nephrology, and Orthopedics

Prepare and Lead Training Seminars

Prepare and Lead Investigator’s Meetings

Biosafety Submissions

Drug Trial Experience

Biological Trial Experience

Device Trial Experience

International Monitoring

Medical Device Technical Support

Amy Joan Muchinsky

33 Pickering Street

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

Page 2 of 6

CLINICAL REGULATORY OPERATION MANAGER

Working knowledge of FDA regulations relating to research on clinical trials as applied to local and federal submissions.

Provide regulatory leadership and guidance to Clinical Teams during the development, review and approval process of clinical trials .

Work collaboratively with Compliance, Legal and Buisness Development to ensure that materials approved by regulatory authorities are used within intended guidelines and contracts are executed appropriately.

Participate in the training of regulatory and clinical staff on upcoming and ongoing clinical trials.

Work directly with medical and scientific personnel to develop and review content and format of documents, assuring federal and local compliance as well standard operating procedures.

Competently serve as the liason between corporate sponsors, federal agencies, and academic institutes.

Provide input into process improvement of systems and/or processes.

• B.S. in Psychology, Washington State University

• Graduate studies in Clinical Psychology

• Emphasis in Neurochemistry

• Double minor, Alcohol/Drug Studies and Women's Studies

• Licensed Counselor Washington State

• Paralegal Studies at The University of Texas at Austin PROFESSIONAL TRAINING

• CITI Certifications and DMID Certifications

• NIH Information and Management Awareness Certifications

• EHSO Research Lab Safety and Biosafety Certifications

• Certification in Paralegal Studies

• Medical Device Approval Process, Barnett International

• Advanced Clinical Research Associate Training, Drug Information Association

• Clinical Research Associate Training, Otsuka America Pharmaceuticals

• Post Baccalaureate Clinical Counseling Hours, Group Health Cooperative EDUCATION

Amy Joan Muchinsky

33 Pickering Street

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

EMPLOYMENT HISTORY

Emory University SOM: Department of Pediatrics, Division of Infectious Diseases Clinical Regulatory Operations Manager. April 2022- Present Serve as Regulatory Lead for various clinical studies, sponsors and research groups including NIH (DMID, DAIDS, DAIT, VRC), Vaccine Treatment and Evaluation Unit (VTEU), RDCN, and Industry Sponsors. Lead and manage the preparation, submission and maintenance of regulatory filings in a timely accurate and complete manner. Conduct quality review to ensure compliance to submission standards. Coordinate with multiple departments and sponsors to assure regulatory completeness throughout study duration from start up to close out including appropriate archival and maintenance of regulatory submissions and correspondence. Provide expertise and guidance to the regulatory team. Strategic planning with leadership team to support clinical research teams fiscally and operationally. Develop and implement a web based application to capture data for clinical research, data bases for projects and regulatory management (REDcap). Lead and mentor clinical teams throughout the duration of the clinical research process including the development of regulatory personnel and department growth. Adapt a variety of strategies to successfully execute trials which may involve multiple collaborators (e.g., government, corporate sponsors, CRO, Central IRB, local IRB, and internal departments) utilizing effective organization and communication to successfully execute the study.

Emory University SOM: Department of Pediatrics, Division of Infectious Diseases Clinical Trials Regulatory Specialist, SR. August 2018-April 2022 Support research efforts by facilitating regulatory compliance throughout the clinical trial duration for studies involving human subjects. Apply knowledge of FDA, GCP and IRB CFRs to guide compliant clinical research trials from start up to close out and through the application process. Lead and mentor clinical teams throughout the duration of the clinical research process including the development of regulatory personnel as the department grows. Adapt a variety of strategies to successfully execute trials which may involve multiple collaborators (e.g., government, corporate sponsors, CRO, Central IRB, local IRB, and internal departments) utilizing effective organization and communication to successfully execute the study. Facilitate, organize, manage and execute regulatory priorities for Emory Children’s Center. Execute fast track submissions during COVID 19, while continuing to deliver successful oversight to ongoing pediatric and adult infectious disease trials. Maintain current knowledge of industry standards that could lend to greater efficiency and compliance. Apply and communicate staffing and budgetary parameters to advise Investigators of best approaches to adapt with current research demands. Approach regulatory obstacles with a systematic approach to resolution. Objectively organize resolutions for the betterment of the research team and confidently provide guidance. Avail open minded discussions for all staff to grow and inspire within the team. Receive feedback with an open mind, provide a work platform of equal opportunities, and address concerns with discernment. Create an environment of inclusivity and team unity. Independent Clinical Research Consultant

March 1997 to August 2018

P rovided technical expertise including project management, site monitoring, and regulatory guidance to specific projects involving clinical research in the biomedical, pharmaceutical and the medical device field of medicine for adult and pediatric populations. Organized and maintained routine communications with sites, CRO, sponsor, and international project teams. Routine responsibilities included; project forecasts, timelines, contracts, budgets, and staffing. Page 3 of 6

Amy Joan Muchinsky

33 Pickering Street

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

Page 4 of 6

• A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older.

• A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults.

• A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

• Phase I, Open-Label, Dose-ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine

(mRNA-1273) in Healthy Adults.

• A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older.

• A Phase 3, Randomized, Double-blind, Placebo-controlled Study Assessing the Efficacy and Safety of Anti- Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2.

• A Phase 2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of a SARS-CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older

• Determining RSV Burden and Outcomes in Pregnant Women and Older Adults Requiring Hospitalization.

• Pediatric Specimen Collection Protocol for Outbreaks of Diseases of Public Health Importance.

• A Novel Device to Collect Droplets Generated from the Lung of COVID-19 Patients.

• A Prospective Cohort Study to Assess Longitudinal Immune Responses in Hospitalized Patients with COVID-19.

• Assessment of CMV-specific T Cell Responses by Flow Cytometry with Intracellular Cytokine Staining to Predict CMV Infection Risk in Pediatric Solid Organ Transplant Recipients.

• A Phase 1, Open-label, Multicenter, Non-comparative Pharmacokinetics and Safety Study of Intravenous and Oral Isavuconazonium Sulfate in Pediatric Patients.

• A Prospective Study of Acute Flaccid Myelitis (AFM) to Define Natural History, Risk Factors, and Pathogenetic Mechanisms.

• Group A Streptococcus (GAS) Molecular Epidemiology and Ecology. Collaborate on the development of corporate SOPs, protocols, CRFs, MOPs, source documents, monitoring report templates, and other study materials. Delegated and managed remote and office based teams. Provide regulatory guidance, develop training programs, site selection, data management, study start up, execution of investigator meeting, SIV, IMV, and COV throughout the US and Europe in compliance with local and federal regulations. Provided technical support during surgical procedures for an investigational medical device. Otsuka America Pharmaceuticals, Inc. Rockville, MD Clinical Research Associate-Jun e1995 to January 1996. Clinical Research Assistant- January 1995 to J une 1995

Monitored two-phase Ill pivotal trials and one compassionate use trial in the therapeutic area of cardiology. Followed federal regulations, corporate standard operating procedures and good clinical practices. Conducted 100% source verification, data resolution, adverse event reporting, concomitant medication reconciliation, and drug accountability verification. Monitored five days a week, multiple sites throughout the United States. Implemented a system to collect, track, and adjudicate all morbidity and mortality data. CURRENT CLINICAL TRIAL EXPERIENCE

Amy Joan Muchinsky

33 Pickering Street

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

Page 5 of 6

• A Phase 4 Study using a Test-Negative Design to Evaluate the Effectiveness of a 20-Vaelnt Pneumococcal Conjugate Vaccine against Vaccine-Type Radiologically -Confirmed Community Acquired Pneumonia in Adults 65 Years of Age.

• A Master Phase 1/2/3 Protocol to Investigate the Safety, Tolerability, and Immunogenicity of Bivalent BNT162b2 RNA- Based Vaccine Candidate(s) in Healthy Children.

• A Phase 2, Two-Part (open-label [part 1] followed by Observer-Blind/Randomized [Part 2]) to evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRBA-1273.214 SARS-CoV-2 Vaccine in Participants Aged 12 weeks to

< 6 months.

• A Phase 3, Randomized, Statified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRBA-1273 SARS-CoV-2 Vaccine in Adults 18 Years and older.

• A Phase2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Palcebo- Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRBA-1273 SARS- CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age.

• A Phase 1, Open-Label Dose-Finding Study to Evaluate Safety,, Tolerability, and Immunogenicity and Phase 2/3 Placebo- Controlled, Oberserver-Blinded Safety, Tolerability, and Immunogenicity Study of A Sars-COV-2 RNA Vaccine Candidate Against COVID-19 in Healthy Chidlren and Young Adults.

• A Phase 1/2, Randomized, Observer-Blind, Controlled, Multi-Center Study to Evaluate Safety, Reactogenicity and Immunogenicity of GSK Biologicals’ Respiratory Syncytial Virus (RSV) Investigational Vaccine Based on the RSV Viral Proteins F, N and M2-1 Encoded by Chimpanzee-Derived Adenovector (ChAd155-RSV).

(GSK3389245A), when Administered Intramuscularly as a Single Dose or as Two Doses According to a 0, 1-Month Schedule, to Infants aged 6 and 7 Months.

• A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY).

• A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody with an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY).

• Detection of Streptococcus Pneumoniae or Pneumococcal Antigens in Nasopharyngeal Carriage and Urine of Healthy Children (The SIGNAL Study).

• A Randomized, Single-Blind, Placebo-controlled, Dose-escalation Phase 1b Study to Evaluate the Safety and Immunogenicity of an Intranasal Live Attenuated Respiratory Syncytial Virus (RSV) Vaccine in Seropositive Young Children.

• A Study to Evaluate the Safety, Reactogenicity, and Acceptability of a Placebo Microneedle Patch in Healthy Infants and Young Children.

• Neonatal Enterovirus and Human Parechovirus Viral Sepsis: Natural History and Predictors of Morbidity and Mortality.

• Phase 4 Study to Assess the Safety and Immunogenicity of VAXCHORA (Cholera Vaccine, Live, Oral) in Children 2 to <18 Years of Age.

• A Phase 2B, Randomized, Placebo-Controlled, Observer-Blinded Trial to Evaluate the Safety, Tolerability, and Immunogencity of a Respiratory Syncytial Virus (RSV) Vaccine in Pregnant Women 18 through 49 Years of Age and their Infants.

• A Phase 3, Randomized, Double Blinded, Placebo Controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants Born to Women Vaccinated During Pregnancy.

• Efficacy, Immunogenicity, and Safety of High-dose Quadrivalent Influenza Vaccine Compared with Standard-Dose Quadrivalent Influenza Vaccine in Children 6 Months through 35 Months of Age.

• A Parallel-Group, Phase II/III, Age De-Escalation, Dose-Escalation, Modified Double-Blind, Multi-Armed, Placebo- Controlled Study to Assess the Safety and the Effectiveness (immunogenicity) of a SARS-CoV-2 Adjuvanted Recombinant Protein Vaccine for Prevention against COVID-19 in Healthy Children Amy Joan Muchinsky

33 Pickering Street

Danvers, MA 01923

Mobile: 512-***-****

E-mail: ad21e4@r.postjobfree.com

Page 6 of 6

• Phase III, Multicenter, Placebo-controlled, Double Blinded Study to Evaluate Efficacy of a Vaccine in Adults on Hemodialysis.

• A Prospective, Multicenter, Randomized, Open L abel, Parallel Arm, Comparison Study in Subjects with End-stage Renal Disease.

• A Prospective, Multicenter, Randomized, Open Label, Parallel Arm, Comparison Study in Subjects with Stage 4 Chronic Kidney Disease.

• Phase IV Non-randomized, Consecutive enrollment, One-year Study of Patients Treated with a Finger Implant.

• Open Label Dose Titration Study in Chronic Daily Headache Prophylaxis.

• Compassionate use Multi-center Device Trial in Patients with Severe Gastroparesis.

• Phase IV Single-center Drug Safety and Efficacy Trial in Patients with Spasticity and Dystonia Secondary to Acquired Brain Injury.

• Phase III Multi-center Worldwide Device Trial in Patients with Gastroparesis.

• Phase III Multi-center Drug Tolerability Trial in Patients with Multiple Sclerosis. PERSONAL DETAILS

Born and raised in Washington state.

Youngest of three sisters.

One pet, Sadie dog age 11.

Lived in Maryland, Austin, New York,

Atlanta and current city greater Boston.

Mother of three girls ages 24, 21 and 17.

Favorite hobbies include enjoying family,

friends, home renovations, travel, tennis,

pickleball, beach life, lake life, boating, water

sports, paddle boarding, biking, walking, yoga,

cooking and a good book.

Most recent travel experience, Italy, Spain and

Costa Rica.

PAST CLINICAL TRIAL EXPERIENCE

Contact this candidate