Consultation services at all stages of the biomedical clinical trial lifecycle. Strategic planning, stakeholder engagement, grant writing, literature reviews, protocol & SOP development, regulatory registration & compliance, data capture & analysis, staff training, quality assurance & monitoring, results reporting, and manuscript development.

• Field-based establishment and maintenance of scientific relationships with 193+ Key Opinion Leaders (KOLs) and healthcare professionals (HCPs)• Conducted appropriate scientific exchange with KOLs on medical, clinical, therapeutic, epidemiologic, and scientific topics to advance joint understanding of disease state and novel treatment protocols. Acted as a scientific resource to KOLs and HCPs and reactively responded to inquiries on trial data and product• Developed and executed KOL engagement strategy with personal accountability for results to maximize efficiency within territory – relationships forged in both the US Southeast and Southwest with additional collaborators in Midwest and Northeast. Conducted 300+ meetings in 15 states, exceeding KPIs by >45%• Maintained up-to-date knowledge of Independent Delivery Networks (IDNs) and Veterans Affairs (VA) systems, academic research centers, clinical, and therapy practices related to patient care, disease management, and research within territory• Represented company at continuing medical education events, medical congresses, conferences, and patient advocacy forums. Identified and communicated medical/scientific insights and trends strategically relevant to company regarding treatment landscape and unmet needs of HCPs, patients, and researchers. Led Competitive Intelligence (CI) Working Group.• Invited conference presentation "Implementing Practical Procedures to Account for Placebo-Induced Effects in Psychedelic Trial Results" at the 6th Annual Neuropsychiatric Drug Development Conference (2023)

• Partnered with CSO & consulting group to conduct market analysis on competitor products, pursuant indications, & unmet patient need (market size) to create strategic MDMA development pipeline.• Implemented program strategic priorities & key project evaluation criteria for investigator-initiated trials, increasing productivity & scope by >30%.• Invited conference presentations at Horizons 15th Annual Conference on Psychedelics (2022) "Update on MDMA-AT for PTSD and other indications" and 3rd Annual Psychedelic Therapeutics and Drug Development Conference (2023) "Designing Trials and Investigator-Sponsored Research Programs in Psychedelics"

• Provided technical assistance to investigators on procedural feasibility, budget development, regulatory & ethics submissions preparation, & site training & readiness.• Developed & presented monthly to executive committee & quarterly to the board related to project status of >48 initiatives, issue escalation, & proposals of new growth opportunities.

• Established & maintained relationships and implemented process & procedure for investigator concept development & submission to support scientifically rigorous study designs & novel research aims.

• Coordination of HIV prevention and treatment clinical research protocols portfolio in South Africa, Brazil, and Malawi (NIH, CDC, and HRSA-funded) including behavioral, biomedical, mHealth, and device trials. Monitored key economic indicators of program planning and progress • Project management duties including start-up logistical and needs assessments, grant and budget drafting, timeline and deliverables tracking, regulatory registration, data and product quality control, vendor agreement negotiation, SOP development, reporting• Development and monitoring of study data collection tools and databases; including cost-effectiveness and qualitative sub-studies. Data management, collation, cleaning, and preliminary analysis – primarily in Stata, with additional skills in Access, ODK, QDS, Qualtrics, REDCap, Python, and R• Conduct site-level staff protocol trainings and quality assurance/compliance audits quarterly; average in-country time: 25%• Directly managed teams at 3 in-country implementing partner orgs, indirect oversight of 20-30 research sites spanning multiple trials (4-6 concurrently).• Oversaw 2 device trials culminating in evidence for Clinical Practice Guidelines for HIV self-testing kits in Sub-Saharan Africa.• Co-author on 20+ publications and conference abstracts

• Wrote and edited Stata code blocks, collated and co-presented data for analysis of economic indicators of the LINKAGES HIV care improvement program across 11 African countries

• Screened and consented patients in English and Spanish for survey evaluating barriers to accessing abortion care. Managed participant reimbursement and study assets, tracking of enrollment progress and metrics, and liaised and developed rapport with site providers to identify potential participants. • Collated, cleaned, and conducted preliminary analysis on survey data in support of manuscript publication.

• Conducted HIV and HCV risk reduction counseling in English and Spanish and administered rapid HIV and HCV blood tests at clinic, satellite locations, and using mobile outreach van to travel to remote areas to provide prevention and linkage to care services. Conducted phlebotomy for whole blood specimens to confirm preliminary positive results on rapid tests. • Provided STI education and safer sex materials, as well as information and supplies for substance use harm reduction and overdose prevention (e.g. needle exchange and NarCan training). • Contributed to strategic plan for expanding mobile outreach services to include STI testing and treatment, as well as facilitating linkage to PrEP and HIV-positive case management services. • Worked primarily with Mexican, Spanish, and Indigenous communities, including health fairs for screening on-site at homeless encampments and special coalition events on Navajo reservation lands. • Participated in regional and statewide NMDOH planning meetings and trainings, as well as Tribal infectious disease summits and working groups.• Assisted Research Director with Stata code files for analysis of PWID survey outcome data and program evaluation metrics.• Established and ran social media accounts (Instagram and X) for "Es Mejor Saber" - the clinic's branded HIV/HCV outreach program.

• Coordination, regulatory registration, and administrative operations for multiple biomedical HIV prevention clinical trials including: oral TDF/FTC safety and efficacy for pre-exposure prophylaxis (iPrEx), oral MVC safety (HPTN 069), rectal TFV -RG gel safety (MTN-017), VCV/MK-2048 IVR pharmacokinetic (PK), oral TDF & TDF/FTC PK, CAB-LA injectable safety (HPTN 077), up to 4 concurrently.• Training, supervision and mentorship of three research associates, program assistant, lab coordinator, and interns. Responsible for data quality control for >300 participants • Contributed to development and evaluation of site regulatory and quality management best practices. Collaborated on community engagement materials, events, recruitment ads, media pieces• Led data collation and content drafting for site selection questionnaires and NIH grant applications to bid on/propose participation in new network/IIS trials. Represented site on international investigator calls and at annual network (HPTN, MTN) conferences • First author on 1 publication and 1 conference talk and co-author on 4+ publications and conference abstracts

• Contributed to development of site SOPs, study SSPs, case report forms, source records, recruitment campaigns and processes; internal quality assurance and management, external site selection questionnaires, grant applications, and sponsor-reporting; and PI-led abstract and manuscript development.

• Data quality control review >200 participants• Conducted HIV testing and risk reduction counseling• Participant screening, informed consent discussions, eligibility assessment, and completion of case report forms.• Conducted HIV testing and risk reduction counseling.• Conducted Point of Care (PoC) lab diagnostics and biologic specimen processing for shipment and storage.