CV
Eileen B. Leary, PhD, RPSGT
Curriculum Vitae
Tenacious sleep nerd with over 20 years of collaborative clinical research experience.
Senior scientist known for inspiring teams to successfully deliver patient‑centric research studies.
- PhD in Epidemiology and Clinical Research from Stanford University
- Rare ability to effectively communicate between diverse stakeholders
- Experience includes 30+ clinical research studies, 80+ scientific publications, and 30+ presentations
Currently leading biopharmaceutical research focused on helping people achieve an amazing night's sleep.
Education
6/2020 PhD, Epidemiology and Clinical Research, Stanford University School of Medicine
Thesis: Sleep and Death: The Relationship Between REM Sleep and Mortality
6/2013 MS, Epidemiology and Clinical Research, Stanford University School of Medicine
Thesis: The Association Between Periodic Leg Movements (PLMs) and Sleepiness in the Wisconsin Sleep Cohort
6/1995 BA, Psychology, University of California, San Diego
Provost Honors; Honors Thesis: Effects of Smoking Cessation on Sleep; Education Abroad Program (University of College Cork, Ireland)
Professional Credentials and Memberships
10/2020 – present American Academy of Sleep Technologist Fellow (FAAST)
4/2019 – present World Sleep Society Member
11/2016 – present Basic Life Support (BLS) Provider
2/2012 – present ABSM Registered Sleep Technologist (RST) (# 2791)
7/2010 – present Sleep Research Society Member
11/2007 – present California Sleep Society Member
6/1998 – present BRPT Registered Polysomnographic Technologist (RPSGT) (# 2157)
5/1997 – present American Association of Sleep Technologists Member
Employment and Research Experience
1/2023 – present Axsome Therapeutics (San Francisco, CA - remote)
Senior Director, Clinical Development
Served as Molecule Lead for sleep and neuroscience programs. Responsible for developing and leading an integrated sleep/neuroscience clinical program spanning all phases of research.
- Aligned clinical research activities with core business objectives across 2 molecules and 7 therapeutic areas (narcolepsy, idiopathic hypersomnia, obstructive sleep apnea, shift work disorder, attention-deficit/hyperactivity disorder, major depressive disorder, and binge eating disorder).
- Propelled company visibility as a leading entity in the sleep field through strategic presentations of scientific findings at prominent conferences, securing partnerships with 6 influential key opinion leaders, and orchestrating >20 high-impact engagements with key opinion leaders.
- Served as sleep medicine subject matter expert, driving strategy and decision-making by staying informed on the latest advancements in clinical research, therapeutic areas, and regulatory guidelines. Attended 4 scientific conferences, 1 PERI course, 3 NASEM workshops, and 4 CDER seminars.
- Drove the development/execution of 16 clinical studies from early phase development (hepatic, TQT, and food effect studies) through post-marketing requirements (pregnancy studies).
- Authored >15 pivotal documents including study protocols, pediatric study plans, clinical study reports, pINDs, briefing books, investigator brochures, and annual reports through close collaboration with key stakeholders across regulatory affairs, biostatistics, CMC, medical affairs, commercial and executive leadership teams.
- Led 5 clinical study teams to ensure timely initiation and meticulous execution of high-quality, cost-efficient clinical trials in partnership with clinical operations and contracted research organizations (IND submission through Phase 4 studies).
- Analyzed and interpreted clinical trial data, effectively communicating insights to internal and external stakeholders, including publication of 4 original abstracts.
- Championed a culture of scientific rigor, collaboration, and innovation by fostering open communication and providing mentorship to junior colleagues.
7/2020 – 1/2023 Jazz Pharmaceuticals (Palo Alto, CA)
Director, Clinical Scientist Lead
Drove the post‑approval research strategy for Global Medical Affairs. Responsible for identifying and prioritizing data gaps, designing and implementing real world evidence research studies, and articulating to matrix teams and senior leadership how findings can be applied to business and medical decisions.
- Hired, trained, and supervised team of high functioning clinical scientists. Served as mentor to team members and outside colleagues by promoting and prioritizing professional development.
- Designed 5+ studies that were patient centric, feasible to operationalize, and generated evidence of interest to patients, health care providers, and the scientific community.
- Led multiple high‑functioning, cross‑functional teams to successfully develop and deploy research studies with intelligence, compassion, enthusiasm, and integrity.
- Served as sleep and clinical science subject matter expert to matrix teams to ensure scientific rigor in research studies.
- Published 3 peer-reviewed manuscripts and 12 original abstracts presented at scientific conferences.
7/2018 – present Eileen Leary (Independent) (San Francisco, CA)
Sleep Research Design and Analysis Consultant
Provided strategic insight and clinical research support including designing clinical trials, writing proposals, designing questionnaires, constructing data analysis plans, performing data analysis, interpreting results, and writing manuscripts.
4/2010 – 5/2011 San Francisco VA Medical Center (San Francisco, CA)
Consultant, Clinical Trial Operations
Advised Dr. Thomas Neylan's research team on deployment of NIMH's 1‑million‑dollar Cognitive Behavioral Treatment of Insomnia in Post-traumatic Stress Disorder Study: a randomized, 2 arm controlled trial examining whether CBTi improves sleep in PTSD patients.
- Developed strategy to launch a complex neurocognitive test battery for the clinical trial.
- Authored quality control procedures and training materials to ensure the ongoing integrity of the research data.
3/2009 – 6/2020 Stanford Center for Sleep Sciences & Medicine (Palo Alto, CA)
Senior Manager of Clinical Research
Responsibilities included leading scientific and technical initiatives, writing grants/proposals, performing statistical analysis and power calculations for grant applications/publications, designing research studies/clinical trials, developing budgets, negotiating contracts, and actively building successful collaborations with internal and third‑party organizations.
- Project Director for the Stanford Technology Analytics and Genomics in Sleep (STAGES) study: a prospective study that will sleep related data on 30,000 sleep clinic patients (age 13 and up) including genetic and phenotypic data.
Managed study at the strategic level to ensure that the project progressed on time and on budget. Chaired Operations Committee, coordinated development of the data management portal, provided high‑level oversight for data collection, and managed the databases and servers for secure storage and sharing.
- Project Director for the Alliance Sleep Questionnaire (ASQ): an online questionnaire that uses complex, branching logic to identify potential sleep disorders.
Partnered with stakeholders from 5 institutions to develop the ASQ's content, conducted the pilot study, managed deployment, and integrated the new tool into the core workflow at Stanford's Sleep Clinic. Responsible for the ongoing management of the ASQ (monitoring data acquisition and integrity, assessing data quality, developing scoring algorithms, and performing data analysis). To date, the ASQ has been completed by over 20,000 people, is critical for >10 research studies (including STAGES and Google baseline pilot), and has become standard of care at the Stanford Sleep Medicine Center.
- Helped department secure >40 million dollars in funding by directing the submission of 15 grant applications (9 funded).
Grants included an 18‑million‑dollar family foundation grant to build a prospective cohort of 30k sleep clinic patients and a 7.85‑million‑dollar NIH P01 grant to research the genetic, neurobiological, and immunological basis of type 1 narcolepsy.
- Provided guidance and mentorship to >20 Masters and PhD students from Technical University of Denmark taking part in the Transatlantic Sleep Medicine & Technology program.
- Database Architect/Administrator for the Stanford Sleep Cohort and Narcolepsy Cohort.
Created system to link clinical, research, and sleep study data on >40,000 individuals including biological data on >5,000 narcolepsy cases and >15,000 controls. Optimized data security and operational effectiveness by providing technical expertise and developing both the schema and data dictionaries.
- Implemented and managed Stanford's Multi‑site PSG Triple Re‑Score Project.
Authored manual of operations for the Stanford Site, developed a partnership with Philips Respironics to streamline data‑export of >500 studies, hired/managed scoring techs, produced final dataset, and provided regular updates to the project's steering committee.
- Program and Technical Director of Stanford's Accredited Sleep Technologist Education Program.
Developed A‑STEP's course curriculum (including speakers and materials), managed team of 12-15 presenters, handled all administrative requirements (enrollment and record keeping), and presented lectures on various topics ranging from sleep scoring to patient hook‑ups.
- Provided operational oversight for 10 clinical studies with sample sizes ranging from 40 to over 8,000.
- Composed/managed >40 department active IRB protocols (involved updates/renewals, adherence to regulations, and coordination of inter institutional agreements with >25 collaborators).
11/2002 – 2/2009 Stanford Sleep Research Center (Stanford, CA)
National Coordinator / Central Scoring System Manager
Responsible for overall operations on NHLBI's 14.1‑million‑dollar Apnea Positive Pressure Long‑term Efficacy Study (APPLES): a 6‑month, randomized, double‑blind, 2 arm, sham‑controlled, multi‑center trial to assess the long‑term effectiveness of nasal continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) with >1,516 enrolled subjects.
- Managed technical staff and Central Scoring System for both APPLES and APPLES fMRI Study.
Designed and implemented a database to track >20,000 sleep studies. Developed, documented, and implemented quality control and quality assurance procedures. Hired and managed team of up to 15 remote technicians.
- Supervised staff and data collection at Stanford's Clinical Center.
Ensured high‑level care was provided to the >400 subjects enrolled at Stanford. Recruited, trained, and supervised a diverse team of 12‑16 staff members.
- Ensured program excellence across 5 university, hospital, and private practice sites.
Performed annual site audits, organized and chaired monthly quality assurance meetings, provided operations advice, and made recommendations to promote staffing diversity. Monitored monthly subject enrollment and retention goals for all clinical centers.
- Created procedures and tools to foster standardization and data integrity.
Collaboratively produced a detailed manual of operations and >100 case report forms to help ensure adherence to protocols and the collection of consistent, high‑quality data.
- Collaborated in the creation of a robust data entry and management system that effectively collected and stored >8 million data points.
- Assisted Principal Investigator in developing/implementing subsequent clinical trials, including APPLES fMRI, APPLE CORS, and TOPS.
7/2000 – 11/2002 SleepQuest Inc. (Redwood City, CA)
Project Manager / Stanford Liaison
Managed projects for Stanford's Dr. William C. Dement to raise public awareness of the importance of sleep.
- Partnered with Stanford physicians to develop and deploy a successful annual sleep education course for a family practice clerkship (including tests for assessing efficacy).
- Joined forces with third party organizations to incorporate the importance of sleep into college and high school curricula.
- Produced educational materials for long‑haul truck drivers to improve their sleep quality and safety practices.
- Designed research protocol for testing the efficacy of SleepQuest's treatment pathway. Results published and presented at 2006 SLEEP conference.
- Improved CPAP adherence for over 100 patients through one‑on‑one appointments.
12/1997 – 7/2000 San Francisco VA Medical Center (San Francisco, CA)
Contractor
Key contributor on research team examining the effects of Post‑Traumatic Stress Disorder on sleep.
- Analyzed and scored sleep studies per project‑specific metrics.
- Performed patient hook‑ups and calibrated data collection software.
4/1997 – 7/2000 UCSF Mt. Zion Sleep Disorders Center (San Francisco, CA)
Registered Polysomnographic Technologist
Conducted MSLT, MWT, and overnight sleep studies (PSGs) including full apnea hook‑ups, PAP/BiLevel titrations, TCCO2, and PES calibration and monitoring.
- Scored >150 sleep studies for sleep stages, breathing events, arousals, and leg movements.
- Improved patient health by developing/implanting a proactive PAP adherence program.
Teaching / Invited Lectures
Publications
Peer Reviewed Articles
Book Chapters
Abstracts
I'm always interested in collaborating on new sleep science projects. Just started brainstorming or ready to analyze results, let's connect