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Physician Assistant Clinical Research

Carlsbad, CA
July 25, 2020

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Julia Luise Ortega PA, MHS *

Julia Luise Ortega PA, MHS

**** ********* **., ********, ** 92010

Professional Summary: 760-***-****/ Innovative professional with deep clinical trials and patient care experience with leadership roles at biotech companies in the San Diego area to include a genetics start-up. I have 28 years of experience in data driven clinical trial research and strategic program development and oversight and a broad and comprehensive knowledge of direct patient care with an advanced Physician Assistant and Masters in Health Science degrees from Duke University School of Medicine. A strength is my ability to interact effectively with clinicians and scientists. Additionally, I leverage strong teamwork and a healthy culture to dynamically lead and drive initiatives across multiple functional teams. Career Illumina, Inc. (2015 – Present)

Performance: Director, Scientific Research and Strategic Programs (2017 – Present) Sr. Manager, Strategic Partnerships (2015 – 2017)

Manage a team with a portfolio of various clinical research studies that include clinical whole genome sequencing (cWGS), cfDNA and RNA-SEQ. Oversee and drive research efforts to include: agreement execution, site and clinical research organization selection and daily management, site onboarding and training, site monitoring and auditing, electronic trial master file and study databases, timely data input and quality, case report form development, protocol and consent form writing and regulatory submission, data lock and manuscript writing. Lead cross functional operational team alignment with laboratory specific standard operating procedures and work instructions that include sample approval, notification of sample quality control failures and sample tracking through the pipeline. Communicate sample volume, pipeline projections regularly to internal teams and executive leadership. Interact routinely with finance, legal, regulatory, sales/account teams, marketing, public relations, investor relations and social media team. Manage multi-million-dollar study budgets and regularly look for opportunities to be more cost effective. Lead the daily management of Illumina’s philanthropic effort, the iHope Program which provides no cost cWGS to patients and their families with a suspected rare and undiagnosed disease. Manage over thirty domestic and international clinical partnerships related to this program to include two clinics in Mexico which require onsite (bilingual) consenting of over 60 individuals every three months.

Human Longevity, Inc. (2014 – 2015)

Head of Alliance Management, Research Operations, and Quality Built the Alliance Management department and assisted the Chief Scientific Officer with developing the clinical research strategy to include alignment with the company’s business plan and goals. This effort extended to concept sheet development, protocol writing, IRB submissions, patient recruitment, cross-functional team coordination, data cleaning and analysis and manuscript submissions.

Managed the research budget as well as predicted costs and month over month financial tracking of project expenses. Served as the primary liaison to pharmaceutical, academic and biotech clients as well as 3rd party vendors.

Julia Luise Ortega PA, MHS 2

Developed quality standards across the processing pipeline. Responsible for the overall operational management and performance excellence of cross-functional genomic teams to include a focus on whole genome, microbiome and metabolite sequencing and analysis with integrated clinical phenotype data.

Maintained the alliance management and operational efforts across the research, clinical, bioinformatics, IT, and finance teams. Developed reporting metrics across the research portfolio that included dashboards for the CSO and executive team. Blue Shield of California (2013 – 2014)

Accountable Care - Sr. Clinical Consultant

Statewide oversight and management of a team of clinicians responsible for implementing clinical programs within Blue Shield’s accountable care collaborations with a focus on care coordination, steerage and diversion and alternative care models to include intensive outpatient care programs, transitional medical clinics and wellness clinics in both the inpatient and ambulatory care setting. Responsibilities included meeting financial and utilization outcome metrics in accordance with the multi- organizational ACO agreements as well as holding all partners accountable for goals and milestones outlined.

Played a key role in infrastructure development and strategic rollout of interventions and performance indicators.

Cultivated excellent client relationships, maintaining ongoing communication and facilitating solutions to address concerns.

Developed and implemented strategic objectives to ensure achievement of profitability goals and a high level of client satisfaction.

Aetna, Accountable Care Solutions (2012 – 2013)

Sr. Clinical Consultant/Care Delivery

Responsibilities included ensuring that Accountable Care Organizations clinical programs are delivered as designed to promote quality outcomes and a decrease in medical spend.

Responsible for the strategic collaboration with ACO partners and health systems and internal partners to include National and Regional Care Management and Active Health Management.

Provided guidance and direction to external vendors, external consultants, consulting team members and/or matrixed staff. Utilize clinical and payer knowledge to proactively identify opportunities for improvement.

Employed strong foundational knowledge of medical and pharmacy claims to drive Care Delivery programs using shared data. Apply communication and diplomatic expertise to influence business and medical thought leaders to assist with driving system wide change.

Julia Luise Ortega PA, MHS 3

Medco Health Solutions/Medco Research Institute (2009 – 2012) Sr. Director of Client Relations/Clinical Programs

[2011 Top Performer, 2010 President’s Award]

Responsible for overseeing the design, implementation, conduct, and analysis of complex pilot programs and research initiatives.

Principal lead for multiple initiatives to include a multimillion-dollar Medicare Part D collaborative case management program between Medco and Coventry. Led the efforts of interventional multidisciplinary teams (physicians, care managers, pharmacists, clinical outcomes analysts and social workers) who focused on at risk seniors to decrease urgent hospitalizations.

Worked closely with multilayered internal processes and regulatory requirements. Managed all strategic partnerships and a client facing team that evaluated client needs, tailoring initiatives based on client’s clinical data. Created training documents and learning aids for internal and external health plan, state, federal, large and small employer payers.

Achieved buy-in across multiple internal and external stakeholders through communication, presentation and networking skills. As part of the leadership team, presented weekly to executive leadership to include chief privacy officer, institute President as well as legal counsel. Developed and oversaw a payer research consortium representing 40 million member lives providing a quarterly webinar educational series and newsletter. UnitedHealth Group (2004 – 2009)

Lead Clinical Advisor (Ingenix) – Southeast Region (2007 – 2009)

[Exceeds Expectations, Nominated for Innovation Award] Highly visible role responsible for the strategic and innovative development of clinical programs to increase revenue growth activity for the health plan. Subject matter expert on Clinical Affairs programs and goals. Led large-scale national projects from the conception stage to rollout and oversight. Responsible for mentoring the clinical affairs staff and providing clinical education to market outreach consultants. Utilized metrics and provider practice patterns to provide strategic guidance to market outreach team.

Met with key medical groups as well as executive leadership to assist with physician and member engagement as well as adoption of national clinical guidelines to include clinical project alignment with NCQA metrics.

Adhered to project deadlines with a revenue growth goal of $5.5 million every six months.

Clinical Advisor/Physician Assistant (Ovations/Evercare) (2004 - 2007) Provided patient care for patients with chronic conditions to include diabetes, hypertension, hypercholesterolemia, Parkinson’s disease, dementia, multiple sclerosis, as well as other diseases.

Julia Luise Ortega PA, MHS 4

Led and mentored a team of over twenty-five clinicians whose focus was to provide comprehensive patient care based on best practices and clinical guidelines. Reviewed bed cost ratios and assisted with analyzing reasons for patient transfers to the hospital.

Coordinated master schedule of on call providers, reviewed leave requests and conducted performance reviews. Formalized a mentoring program for new and existing employees at the site. Enhanced quality of care and conducted process improvement initiatives.

Leveraged communication skills to improve patient outcomes and health plan relationships with large institutional facilities in Maryland. Attended leadership and behavioral management training and nominated for a prestigious national innovative award.

Henry M. Jackson Foundation (2003 – 2004)

Associate Clinical Trials Investigator

Provided patient care for clinical trial volunteers and assisted with eligibility determinations for HIV and anthrax clinical trials. Reviewed safety data to look for adverse trends in studies. Drafted medical reports and study updates for IRB, FDA, and sponsors. Maintained multiple standard and ad hoc protocol tracking reports.

Implemented standard operating procedures and quality control measures to assist with Good Clinical Practices (GCP).

Appointed to the Walter Reed Army Institute of Research (WRAIR) Review Board, which provides clinical oversight of animal studies. Lillian Cardona Family Practice (2002 – 2003)

Physician Assistant

Assessed, diagnosed and managed patients in a bilingual family practice office. Utilized patient care skills to effectively deliver patient care. Performed patient call backs to include addressing acute concerns, delivering laboratory results, refilling medications. MidAtlantic Medical Services, Strategic Planning & Analysis (2001 – 2004) Clinical Research Associate

Managed multiple projects as directed by the Medical Director of Strategic Planning and Analysis with a focus on developing clinical standards of care. Researched literature and claims data to assist with appeals decisions. Reviewed and analyzed Physician Diagnosis Related Group (DRG) reports for determination of under and over-utilization.

Developed clinical guidelines while working closely with Cardiologists, Julia Luise Ortega PA, MHS 5

Gastroenterologists, Orthopedists, and Obstetricians-Gynecologists. Researched and analyzed peer review journals for medical authorization determination. (Consultant 2003-2004)

Community Health Services (1999 – 2001)

Physician Assistant

Assessed, diagnosed and managed multicultural and underserved patients in Internal Medicine, Women’s Health, Pediatrics, Oncology, and OB-Gyn in an inner-city environment.

Lead clinician on the Bureau of Primary Healthcare Health Disparities Collaborative. Researched and wrote multiple grants for Diabetes research. Experienced in suturing and urgent care. Provided care to incarcerated teens at the County Juvenile Detention Center in Hartford, CT.

Duke University AIDS Research and Treatment Center (1997 – 1999) Senior Research Assistant

Participated in all aspects of clinical trials from screening patients to responding to case report form queries. Researched and implemented computerized site specimen tracking system. Assisted with development of center website. Social and Scientific Systems, Inc., (1992-1997)

HIV/AIDS Protocol Coordinator

Drafted and maintained concept sheets, protocols, and masthead publications for the AIDS Clinical Trials Group (ACTG) while working with protocol teams on Phase II-IV HIV clinical trials. Participated in meetings with NIH’s Division of AIDS (DAIDS), regulatory staff and principal investigators. Solicited community representation and coordinated the activities of the Community Constituency Group (CCG). Education: Duke University School of Medicine, Durham, NC Masters in Health Science and Physician Assistant degrees, 1999 Spelman College, Atlanta, GA Bachelors of

Arts degree in English, 1990

Affiliations: CITI – Good Clinical Practice (GCP) Training American Academy of Physician Assistants

National Commission on Certification of Physician Assistants National Health Service Corps (1997 – 2002)

Computer Medrio, Access, Sales Force, Microsoft Project, Smartsheet, Skills: Tableau and multiple electronic medical records software

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