Identified opportunities to collaborate with academic, industry life sciences partners, private, and public health organizations, focusing on quality and process improvement to bridge the gap between scientific evidence and healthcare decisions. Working at the intersections of pharmacoepidemiology, data science, and regulatory science, I collaborate across therapeutic areas with experts to develop impactful medical manuscripts and comprehensive literature reviews.

Led and managed complex non-interventional studies and projects from concept through publication, supporting data-driven decisions through the generation and analysis of Real-World Data (RWD). Provided strategic leadership as the cross-functional local lead partner for the Center for Observational-RWE (CORE), overseeing RWE analysis, budget planning, resource allocation, and reporting. Conducted data gap analysis and applied statistics to support drug development and business priorities. Communicate findings internally with cross-functional groups (e.g., Market Access, Marketing). Disseminated findings, ensured best practices in business operations, and developed biostatistics, study designs, and epidemiology during protocol and product development to secure cross-functional and leadership endorsement aligned with product development strategy and priorities.-Fostered a culture of innovation by encouraging creative thinking during study design and exploring novel methods to generate and utilize RWD for enhanced outcomes. Ensured RWE practices complied with regulatory requirements, Institutional Review Board (IRB) standards, and scientific guidelines.-Published and/or presented at symposia, findings of six studies related to the characterization of disease burden, epidemiology, treatment patterns, and healthcare resource utilization in diabetes, heart failure, lung, and head neck cancer.-Represented the organization in RWD/RWE through participation in industry events, publications, and speaking engagements. Published and/or presented at symposia, findings of four studies related to the characterization of disease burden, epidemiology, treatment patterns, and healthcare resource utilization.•Demonstrated ability to anticipate and prioritize the needs of medical, clinical, and commercial teams, and effectively influence the matrix organization constructively and without conflict.

Identified opportunities within Academic Medical and Healthcare Centers (AMHCs) and delivered lectures to healthcare students and faculty, ensuring policy adherence, raising awareness, and following related SOPs. Coordinated and presented over ten lectures covering diverse subjects such as Health Economics, Epidemiology, Patient-reported Outcomes, the Science of Vaccines, Comparative Effectiveness Research, Clinical Research, Biostatistics, Patient Advocacy, and Patient Engagement. Lectured as a Medical Affairs subject matter expert at the top four local AMHCs, including UPR, Veterans Health Administration, Ponce Health Sciences University, and Universidad Central del Caribe School of Medicine.

Established and engaged external partnerships with healthcare leaders and key opinion leaders (KOLs) across multiple disciplines. Presented scientific updates, including Formulary value propositions, using approved materials to support corporate strategy. Conducted advisory boards and gathered insights aligned with the Medical Affairs leadership team, facilitating cross-functional groups (e.g., Market Access, Marketing), communication of findings. Collaborated with the Clinical Operations Group within the Medical Affairs division, identifying potential investigators for phase II-IV clinical trials and product drug development. Additionally, performed literature reviews, facilitated medical education, and mentored new team members within the Medical Affairs operating model.•Played a key role in launching four new products - Zontivity, Renflexis, Steglatro, and Verquvo - raising awareness among healthcare professionals.•Executed the first local Advisory Board - Patient Advocacy/Engagement in Clinical Research - with diversity and inclusion of researchers. Obtained insights including patient satisfaction with the collaboration of internal and external partnerships.

Managed a team of four professionals, providing expert technical support across the organization and mentoring junior team members. Investigated laboratory processes, facilitating ISO9000 qualification, and ensured compliance with ICH, FDA, USP, and EU Pharmacopoeia standards. Conducted and supported method development and validation activities, designing experiments to solve scientific problems and developing robust methods for analyzing API and excipients. Wrote technical papers and reports, validated methods for quality control data on products used in clinical trials, and prepared protocols and reports. Supported regulatory filings for assigned projects and assisted in the development, approval, and execution of remediation plans to achieve company objectives.

Collaborated on project schedules, led status meetings, managed precise budgets, and facilitated communication with Medical and Program Directors. Assisted in the design of studies and IRB submission of the hepatitis C infectious disease and Pharmacogenomics in infectious diseases.

Served as a Resource Navigator and bio-medical science liaison for the eagle-i Consortium and the National Institutes of Health (NIH) Eagle-I Project. Conducted focus groups, surveys, and experiments with real users in collaboration with the Research Centers in Minority Institutions (RCMI). Assisted in developing and implementing a web-based application to facilitate the discovery of resources available at participating universities. Collaborated with diverse institutions, including Harvard University and others across the USA, such as Alaska, Hawaii, Oregon, Montana, Indiana, New Hampshire, rural New York, Georgia, and Mississippi. Prioritized research resources, conducted landscape analyses of resource databases, and performed baseline program evaluations to foster biomedical networking. Contributed to identifying biomedical resources with potential opportunities for cross-country collaboration in clinical development, translational, and basic science programs by mapping core centers with discovered available resources.

As the Department Chair of the Chemistry Department, I provided comprehensive leadership and direction, teaching Organic Chemistry and Spectroscopy with high academic rigor and student engagement. I meticulously planned and updated curricula to meet and exceed accreditation standards, fostering a dynamic learning environment that prepared students for careers in chemistry, biology, pre-medical, and engineering fields. In my advisory role, I guided students from diverse disciplines, helping them navigate their academic paths and career aspirations. I successfully negotiated for and procured essential equipment and supplies, meticulously tracking the annual budget to ensure the division operated efficiently within financial constraints. I represented the college at national and international scientific meetings, showcasing our department's research and academic achievements. Additionally, I served as the faculty advisor to campus scientific clubs, promoting student involvement in scientific inquiry and fostering a collaborative academic community. My role also included interviewing and recommending prospective faculty members for the Chemistry Department, ensuring alignment with departmental goals. Through these efforts, I contributed to building a cohesive and high-performing faculty team dedicated to academic excellence and student success.

Managed a team of 50 professionals, overseeing personnel, training, and labor relations activities. As the local head of the department, I was accountable for Validation, Regulatory, Process Improvement, and Chemistry Labs. Developed and managed the departmental budget, establishing effective cost control programs to meet financial targets.Delivered comprehensive status reports to stakeholders for budgeting and planning purposes, ensuring clear and transparent communication. Collaborated with cross-functional teams to develop and maintain project schedules and plans. Budgeted monthly departmental expenses and implemented rigorous cost controls to optimize financial performance.Coached employees to achieve individual performance goals, fostering a culture of continuous improvement and professional growth. Established clear communication channels with plant personnel, ensuring alignment and efficient operations. Prioritized and allocated resources based on business needs, ensuring optimal utilization and project success.Formulated policies regarding strategic scientific, engineering, and management issues, driving the department's long-term vision and objectives. Ensured compliance with all relevant regulatory requirements and maintained the highest standards of quality and safety.

Managed a diverse team of post-docs and PhD professionals, delegating tasks to expedite projects and achieve goals. Oversaw validation, support, and improvement of manufacturing processes from fermentations and chemical synthesis, including purification. Led cost reduction and time optimization initiatives, enhancing investigation timelines and operational efficiency. Engaged in R&D of pipeline products and facilitated technology transfer of new processes across multiple manufacturing sites. Ensured consistent quality and regulatory compliance. As a Black Belt Six Sigma Expert, led high-impact projects to improve business processes, using DMAIC methodologies to drive continuous improvement. Analyzed data to identify inefficiencies, implementing strategic improvements. Trained and mentored team members in Six Sigma principles, fostering a culture of quality. Collaborated with cross-functional teams, facilitated workshops, conducted process audits, and presented findings to senior leadership. Tracked project progress and reported on KPIs to ensure alignment with organizational goals