SENIOR CLINICAL TEAM MANAGER

Jessica Guider, MBA, MPH, PMP

EDUCATION

MBA, Health Economics Concentration, 2012

Benedictine University, Lisle, IL

MPH, Epidemiology and Statistics Concentration, 2012 Benedictine University, Lisle, IL

B.S., Microbiology, 2004

Loyola University Chicago, Chicago, IL

THERAPEUTIC EXPERIENCE

Circulatory/Cardiovascular: Arrhythmia, Acute Coronary Syndrome / CAD, heart defects (ASDs, PFOs, etc.), Hypertension, Pulmonary Arterial Hypertension, Stroke, TIA, Peripheral Artery Disease, Ischemia, MI, Revascularization

Dermatology: Eczema

Digestive System: Crohn’s Disease, Ulcerative Colitis Endocrine/Metabolic: Diabetes mellitus and Diabetic Kidney Disease, Peritoneal Dialysis, Gaucher's, Hypoparathyroidism

Infections/Parasitic Diseases: HIV, Hepatitis B and C Mental Disorders: Opioid Addiction, Restless Leg Syndrome Nervous System/Sense Organs: Parkinson ’s disease, Pain management Oncology: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma, Bladder Cancer, Breast Cancer, Prostate Cancer

Rare Disease: Gaucher’s (Pediatric and Adults), Duchenne's Muscular Dystrophy Respiratory: COPD, Asthma

Transplants: Bone marrow, Liver

PROFESSIONAL EXPERIENCE

PPD, Naperville, IL Senior CTM Mar 2019-Present

Clinical Team Manager May 2016-Mar2019

Senior CTM:

Provide oversight and manage clinical deliverables for a clinical program of 3 studies (Phases II, III and IV) in hypoparathyroidism and Gaucher's consisting of 26 NA sites and 8 CRAs. Participation involves start-up through database lock over a period of 24 months. Also provides oversight and manages deliverables for a Phase 2b bladder cancer trial, which includes 17 centers in the US and Canada. Perform all duties of CTM as listed in job title below, in addition to the following: Jessica Guider, MBA, MPH, PMP Page 2 of 8

• Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a large clinical trial or multiple smaller trials

• In accordance with project-specific requirements, may assume Lead/Global CTM responsibilities, Clinical Study Manager responsibilities or take on additional responsibilities, such as management of complex programs

• Liaise with Clinical Manager - CRA regarding current CRA metrics; focus on quality improvements and milestone objectives

• Manage clinical budget

• Manage contingency planning for data cleaning; clinical data listings review; coordinate process for reviewing data listings by a clinical team; escalate quality issues recognized; and provide CRA retraining for quality data as needed

• Participate in site recruitment and budget negotiations; provide contingency planning for meeting recruitment milestones

• Prepare, organize and present at Investigator Meetings CTM:

Managed clinical deliverables for a clinical program of 4 studies in hypoparathyroidism consisting of 26 NA sites and 8 CRAs. Participation involves start-up through database lock over a period of 18 months. Also oversaw a Phase IV study in Asthma which included 26 NA sites and 6 CRAs.

• Manage the execution of project deliverables within contractual timelines and client expectations through all active phases (start-up, recruitment; maintenance; closeout-database lock) of a trial

• Manage clinical resources (CRAs/administrative team) according to projections of ongoing clinical activities to ensure maximum resources are allocated to maintain forward movement of clinical deliverables

• Manage clinical budget; escalate out-of-scope activities to the appropriate individuals for inclusion in a contract modification

• Track, review, and distribute metric updates (regulatory, enrollment, CRF retrieval, subject visits, query, etc.) to external/internal clients/vendors

• Manage contingency planning for data cleaning; clinical data listings review; and, coordinate process for reviewing data listings by clinical team

• Prepare monitoring plan, as well as responsible for the implementation and training of standardized clinical monitoring processes within the study team

• Oversee the development of source documents, CRF/eCRF guidelines and other project-specific forms to be utilized during the study period

• Participate in site recruitment and budget negotiations

• Perform secondary clinical review of case report forms for the purposes of discovery of query trends and CRA re-education

• Provide leadership, coordination, and management of the PPD-customer joint project team through start-up, conduct, tracking, quality, and regulatory compliance management and close-out activities

• Perform review of pass-thru travel costs to ensure the most cost-effective travel practices are being utilized by monitoring staff

• Co-monitor and conduct PSVs and SIVs, if needed.

• Perform review of trip reports of team CRAs to ensure monitoring activities are appropriately conducted and documented for the client according the contractual obligations

• Review essential regulatory documents prior to transmittal to the client for release of initial investigational product

• Present at Investigator Meetings

Jessica Guider, MBA, MPH, PMP Page 3 of 8

Gilead Sciences, Foster City, CA Manager, Clinical Data Management Oct 2012 – May 2016 Managed 12 Data Managers across 3 Therapeutic Areas and 6 programs including: Circulatory/Cardiovascular: Arrhythmia, Acute Coronary Syndrome / CAD, heart defects (ASDs, PFOs, etc.), Hypertension, Pulmonary Arterial Hypertension, Stroke, TIA, Peripheral Artery Disease, Ischemia, MI, Revascularization

Digestive System/Infectious Diseases: Crohn’s Disease, Ulcerative Colitis, HIV, Hepatitis B and C Oncology: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma Rare Disease: Duchenne's Muscular Dystrophy (Pediatric early feasibility study did not progress)

• Cardiovascular therapeutic area lead (i.e. TA-head) with line management responsibility for six clinical data managers

• Served as program manager for all Pan-Asian and Latin American hepatitis C Phase III and Phase IV studies; oversaw and contributed to the completion of all technical and operational clinical data management activities for a group of clinical trials across several compounds through management of internal and external global resources (5 FTE and 3 FSP contractors located in India, UK and South Korea)

• Reviewed requirements and assigned resources to satisfy short-term and long-term staffing needs, and was responsible for putting together highly effective CDM teams and delivering a clear sense of direction for each program

• Worked collaboratively with Programmers, Biostatisticians, CRAs, Project Managers, Medical Monitors, Safety Monitors, Scientists, and Regulatory Managers to meet project deliverables and timelines for complex clinical data acquisition, quality validation and reporting

• Mitigated risks within and across programs by anticipating moderate to complex obstacles and difficulties for clients and acted upon them in order to ensure that team goals were met

• Managed all regulatory submission activities as they related to clinical data management and addressed regulatory submission issues within Biometrics and with other related departments

• Served as the clinical data management representative on audit teams and provided responses to questions and findings from Clinical Quality Assurance (CQA) and regulatory audits at the study, site and vendor level.

• Was responsible for the development and maintenance of monthly, quarterly and annual forecasts

(for department and individual projects)

• Ensured completeness, correctness and consistency of clinical data and data structure across multiple clinical trial programs

• Defined and developed ad hoc reports using system data sources and query/reporting tools such as Crystal Reports, both for delivery to vendors and for use in analysis and testing

• Managed, trained, and mentored a staff of Clinical Data Managers at various levels of proficiency

• Lead initiatives to gather, organize, and analyze interim clinical data from various data sources such as virology and biomarkers, and examined issues from various perspectives in order to ensure alignment of data across sources and within programs

• Participated in the development, review and implementation of processes, policies, SOPs and associated documents governing Clinical Data Management (CDM)

• Led and participated in CDM and cross functional initiative teams for projects such as the roll-out of statistical monitoring tools, risk-based monitoring tools, and improving efficiency in the collection of protocol deviations

• Coordinated project level CDM tasks, while demonstrating knowledge of hands-on work

• Served as the point of escalation for project level issues including processes, timelines, resourcing, performance, etc.

W.L. Gore & Associates, Flagstaff, AZ Clinical Study Manager Jan 2010 – Oct 2012 Jessica Guider, MBA, MPH, PMP Page 4 of 8

Acted as the Clinical Operations Study Lead (COSL) responsible for independently managing multiple medical device trials of moderate complexity and managing a broader range of activities on large multi- center studies for liver disease (peritoneal dialysis) and heart defects (ASDs, PFOs)

• Managed three programs (8 studies total) from protocol development to regulatory submission with two approvals (one 510k and one PMA) domestically and internationally

• Was a contributing member on the clinical development plan (CDP) committee and authored clinical trial protocol synopses, protocols, amendments and informed consent documents for multiple trials

• Prepared the project budget and ensured that it was managed in-line with organizational expectations

• Participated in the feasibility and selection of Investigative Sites/Regions and Investigators domestically and internationally and reviewed and assisted in the negotiation of site budgets

• Managed (when done by a CRO) and conducted site qualifications, site initiations and site training for clinical study personnel at sites and investigator meetings

• Prepared and set guidelines for project timelines across multi-disciplinary project teams, which included clinical operations, data operations, manufacturing, regulatory, sales, marketing, and engineering

• Created, updated, and disseminated key project documents and data collection tools (annual reports to the FDA and other regulatory authorities, project timelines, eCRFs, clinical databases, data validation plans, statistical analysis plans, CRF Completion Guidelines, Monitoring Plans, Charters, etc.) to ensure timely communication of project information to the project team and broader organization, and to ensure compliance with regulatory authorities

• Presented project status and critical information to key stakeholders inside and outside of the organization and continuously monitored and tracked project deliverables using tools such as MS Project

• Coordinated recruitment activities to assist trial sites in building their referral bases and increasing enrollment

• Provided oversight of investigational product supply, forecasting, management and study-level IP reconciliation, and reconciled serious adverse/adverse event and laboratory data, and assisted with patient narrative writing and other data review activities

• Participated in mock and regulatory audits both internally and externally (sites and vendors), and ensured that study sites were prepared for audits through co-monitoring and training

• Coordinated data analysis and prepared clinical reports to support regulatory filings (progress reports, annual reports, clinical study reports, etc.), internal reports, and manuscripts, and coordinated all data output for Medical internal review, CEC and Data Safety Monitoring Board (DSMB) meetings, Annual Reports, publication support and regulatory efforts

• Developed training programs for different levels of audiences (e.g. coordinators, physicians, colleagues, etc.) to ensure proficiency is study implementation (e.g. protocol, data collection, laboratory collections, etc.) and regulatory compliance, and planned and presented at annual Investigator/Coordinator Meetings

• Directed Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs), which included the delegation of tasks, mentoring and training

Premier Research Group, Bloomingdale, IL Clinical Data Manager Jun 2004 – Dec 2009 Coordinated and acted as point of contact for all data operations responsibilities related to data management as the Data Management Lead for the project team on multidisciplinary studies in the following therapeutic areas:

Dermatology: Eczema

Endocrine/Metabolic: Diabetes mellitus and Diabetic Kidney Disease Mental Disorders: Addiction, Restless Leg Syndrome, Pain management Nervous System/Sense Organs: Stroke, Parkinson ’s disease Oncology: Chronic Lymphocytic Leukemia, Non-Hodgkin Lymphoma Respiratory: COPD, Asthma

Transplants: Bone marrow, Liver

Jessica Guider, MBA, MPH, PMP Page 5 of 8

• Worked closely with Clinical Managers, Clinical Research Associates, Biometrics Project Managers, Vendors, and Statisticians on global clinical trials

• Developed study-specific Data Management Metrics, Data Management Plans, conventions for Data Entry and CRF Completion, ad-hoc data management reports and listings, safety review and reconciliation guidelines, coding guidelines (WHO Drug and MedDRA) and other documents required for preparing and completing databases

• Supervised Case Report Form/Electronic Case Report Form development, database (Oracle Clinical and RDC) set-up, data imports/exports, and lock activities

• Reviewed Case Report Forms and Electronic Case Report Forms, data listings, and database to ensure all captured data follow the rules outlined by the protocol and data management plan

• Reviewed protocols and CRFs for potential data collection and representation, database structure or data entry problems, financial status, or change orders and provides feedback to the project team

• Generated paper and electronic queries to appropriate internal or external personnel (investigational sites, vendors, Clinical Research Associates (CRAs), client representatives) to resolve problematic data identified during every aspect of the data management process

• Reviewed responses to queries for appropriateness, resolved any discrepancies and modified the database accordingly

• Performed reconciliation of laboratory safety data (including central laboratories) as well as data from ancillary data sources (such as academic labs, ECGs, pK data etc.) external to the data collection tool (e.g. TFLs)

• Performed adverse event and medication coding

• Performed medical review of data and serious adverse event reconciliation

• Created Data Validation Plans (internal and external validation checks/procedures)

• Performed UAT (validation testing – database screens and checks) for study database setup

• Generated data listings using data review tools (i.e. SQL/SAS)

• Coordinated Sponsor communication and reporting, participates in sponsor audits

• Assisted in companywide validation effort of Oracle Clinical 4.5.3 and Oracle Clinical RDC Onsite; created and tested validation test scripts

LICENSES & CERTIFICATIONS

• Certified Project Management Professional (PMP), Project Management Institute, April 2012

• Certified Six Sigma Green Belt (CSSGB), ASQ, April 2012 PROFESSIONAL DEVELOPMENT

Training while employed at PPD is available upon request. Prior to PPD:

• Completed an online training course for Clinical Research Associates (CRAs) with emphasis on monitoring clinical trials and gaining basic knowledge of CFR Title 21 and the ICH-GCP, Clinical Research Online Training Institute received certificate of completion, June 2007

• Completed course on the fundamentals of clinical research and conducting a clinical trial, University of Chicago received certificate of completion, May 2007 PROFESSIONAL AFFILIATIONS

• Member of the Association of Clinical Research Professionals since 2012

• Member of the Project Management Institute for Project Management Professionals since 2012 Jessica Guider, MBA, MPH, PMP Page 6 of 8

COMPUTER EXPERIENCE

Databases and Applications: MS Access, Oracle Clinical, Oracle Clinical EDC (Inform), SAS, JMP, TOAD, AERS, Hyperion Brio, Medidata RAVE, Documentum, Medrio, DataFax, SPSS, Crystal Reports, FrameMaker, OmniComm TrialMaster, Simplified Clinical, Documentum (FirstDoc), Business Objects, J- Review

LANGUAGES

Native Tongue is English

CLINICAL TRIAL EXPERIENCE

• Oncology: Multi-Center, Open-Label, Interventional Study to evaluate the efficacy and safety of the investigative product in patients with previously treated indolent Non-Hodgkin Lymphoma (iNHL) that is refractory both to rituximab and to alkylating-agent-containing chemotherapy. The primary objective will be to assess the overall response rate.

• Oncology: Multi-Center, Open-Label, Single-Dose, Dose-Escalating Phase I/II study of an investigative product in adult patients with relapsed or refractory CLL, NHL or MM.

• Circulatory/Cardiovascular: Multi-Center, Open-Label, Interventional Study to evaluate the long-term safety and efficacy of a device under investigation in the treatment of ostium secundum atrial septal defects (ASDs).

• Circulatory/Cardiovascular: Multi-Center, Open-Label, Parallel Study to provide an ongoing evaluation of clinical outcomes associated with a device under investigation and a filter when used for embolic protection during carotid artery stenting.

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the efficacy of an investigative product as compared with placebo when used as part of standard medical therapy in chronic angina subjects with incomplete revascularization post-PCI on the composite of ischemia-driven revascularization or ischemia-driven hospitalization without revascularization.

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate whether treatment with investigational product 1 or low dose investigational product 2 reduces atrial fibrillation burden (AFB) in subjects with paroxysmal atrial fibrillation (PAF), and whether combination therapy is superior to individual drug therapy in reducing AFB.

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the effect of an investigative product compared to placebo on the overall occurrence of appropriate implantable cardioverter-defibrillator (ICD) interventions (antitachycardia pacing [ATP] or shock) in adults with ICD or cardiac resynchronization therapy-defibrillator (CRT-D).

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Cross-over Study to evaluate whether the investigative product, when taken prior to exercise, can improve blood flow to the heart

(myocardial perfusion), as assessed by exercise-induced myocardial perfusion defect size (PDS) and total perfusion deficit (TPD), using gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to compare the two treatment strategies; first-line combination therapy versus first-line monotherapy in subjects with Pulmonary Arterial Hypertension.

• Circulatory/Cardiovascular: Multi-Center, Open-Label, Parallel Study to evaluate the effect of an oral investigative drug on the QTc interval in participants with Long QT-3 syndrome. This study will be performed in six cohorts of participants in a sequential manner, four single-dose cohorts followed by two multiple-dose cohorts.

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to compare the efficacy, safety, and tolerability of three doses of investigative product to placebo in adults with pulmonary arterial hypertension (PAH).

Jessica Guider, MBA, MPH, PMP Page 7 of 8

• Circulatory/Cardiovascular: Multi-Center, Observational Post-Market Surveillance Study to evaluate the incidence of adverse events in Japanese subjects with pulmonary arterial hypertension treated with the approved drug.

• Circulatory/Cardiovascular: Multi-Center, Open-Label, Observational Study to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as well as the overall safety and tolerability of the investigative product, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH

(IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy due to increased serum ALT or AST concentrations.

• Circulatory/Cardiovascular: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the effect of the investigative product compared to placebo on the average weekly angina frequency in subjects with chronic stable angina and coronary artery disease (CAD) who have a history of type 2 diabetes mellitus (T2DM), and whether the investigative product can reduce the frequency of angina

(chest pain) attacks, compared to a placebo.

• Dermatology: Multi-Center, Randomized, Blinded, Parallel Study to test the safety of an investigative cream with topical corticosteroid treatment (commonly used in eczema) in patients with severe atopic dermatitis.

• Digestive System: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the safety and efficacy of an investigative compound in adults with active Crohn's disease.

• Digestive System: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the Safety and Efficacy of an investigative compound in Subjects with Moderately to Severely Active Ulcerative Colitis.

• Endocrine/Metabolic: Multi-Center, Randomized, Double-Blind, Parallel Study to evaluate the efficacy, safety, and tolerability of investigative product in participants with diabetic kidney disease

(DKD).

• Endocrine/Metabolic: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to determine the effect of an investigative product when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

• Endocrine/Metabolic: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to determine the effect of an investigative product when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.

• Endocrine/Metabolic: Performance evaluation of the AMIA APD Solution Generation System in patients on peritoneal dialysis using the AMIA APD Cycler.

• Infections/Parasitic Diseases: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to evaluate the efficacy, safety, and tolerability of fixed dose combination (FDC) with or without ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.

• Infections/Parasitic Diseases: Open-Label, Observational, Multi-Center study to evaluate the safety and efficacy of a fixed-dose combination (FDC) treatment under real world use in Japan.

• Infections/Parasitic Diseases: Open-Label, Observational, Multi-Center study to evaluate the safety and efficacy of investigative product administered as per the approved prescribing information in adults with chronic hepatitis C virus (HCV) infection treated in routine clinical practice in India.

• Infections/Parasitic Diseases: Randomized, Open-Label, Parallel, Multi-Center study to evaluate the efficacy, safety, and tolerability of fixed dose combination (FDC) with and without ribavirin (RBV) for 12 and 24 weeks in adults with hepatitis C virus (HCV) infection and Child-Pugh (CPT) class B cirrhosis.

• Infections/Parasitic Diseases: Open-Label, Multi-Center study to evaluate the antiviral efficacy, safety, and tolerability of fixed-dose combination (FDC) administered for 12 weeks in chronic genotype 1 or 2 HCV infected adults who are co-infected with HBV in Taiwan. Jessica Guider, MBA, MPH, PMP Page 8 of 8

• Liver Cirrhosis/Portal Hypertension: Open-Label, Multi-Center interventional study to demonstrate that the TIPS procedure endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.

• Mental Disorders: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to evaluate the safety and effectiveness of an intravenous investigative compound in the treatment of pain in orthopedic patients undergoing hip or knee replacement surgery.

• Mental Disorders: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to evaluate the safety and effectiveness of an intravenous investigative compound in the treatment of pain in patients undergoing abdominal laparoscopic surgery.

• Mental Disorders: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to evaluate the safety and efficacy of an investigative product in patients with Moderate-to-Severe Primary RLS.

• Mental Disorders: Randomized, Double-Blind, Placebo-Controlled, Parallel, Multi-Center study to assess the abuse potential of an abuse deterrent formulation of a commonly prescribed opioid tablet and placebo in recreational opioid users.

• Nervous System/Sense Organs: Multi-Center, Retrospective, Chart Review to identify the occurrence of serotonin toxicity in PD patients receiving antidepressant therapy and the approved product, compared to those receiving the approved product without antidepressants, and anti-PD dopaminergic medications receiving antidepressants but not the approved product.

• Nervous System/Sense Organs: Multi-Center, Investigator-Masked, Randomized, Interventional Study to determine if patent foramen ovale (PFO) closure with the a device under investigation plus antiplatelet medical management is safe and effective and reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) when compared to antiplatelet medical management alone in patients with a PFO and history of cryptogenic stroke or imaging-confirmed TIA.

• Rare Disease: An Open-label, Multicenter, Single-arm, Phase 4 Study of the Effect of treatment with Velaglucerase alfa on Bone-related Pathology in Treatment-naïve Patients with Type 1 Gaucher Disease

• Rare Disease: An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once-Daily and Twice-Daily Dose Regimens of recombinant human Parathyroid Hormone Administered Subcutaneously to Subjects with Hypoparathyroidism

• Rare Disease: A Randomized, Double-blind, Placebo-controlled, Adaptive Study to Evaluate Symptom Improvement and Metabolic Control Among Adult Subjects With Symptomatic Hypoparathyroidism Treated With Recombinant Human Parathyroid Hormone

• Rare Disease: An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects with Hypoparathyroidism

• Rare Disease: A Phase 4, Open-Label, Single-Center Clinical Study of Extended use of rhPTH(1-84) in Hypoparathyroidism

Contact this candidate