Houston, Texas, United States
Highly motivated and results-driven clinical research and program management professional with over 21 years of experience in biomedical research, including over 13+ years in translational and clinical research and operational management focused on oncology, immuno-oncology, and medical devices. Proven track record translating complex science into successful clinical trials, drive asset strategy, and build strong stakeholder engagement. Expertise in strategic program management, clinical operations leadership, and cross-functional collaboration. Expertise includes: • Strategic program management: Full clinical development lifecycle expertise (strategic planning to execution). Proven ability to manage complex clinical programs, drive timelines, mitigate risks, and ensure successful delivery of clinical milestones. Management experience of manufacture process development and tech transfer to GMP manufacture of cell therapy products. • Clinical Operations Leadership: Expertise in all aspects of oncology clinical trial operations, including study design, site selection, CRO management, budget development/management, regulatory compliance (GCP, audit readiness), and strategic alliance management. • Regulatory Expertise: Extensive experience ensuring regulatory compliance (e.g., IACUC, IBC, IRB), preparing compliance documentations (e.g., study protocols, ICFs), and manage regulatory correspondence. • Stakeholder Management & Collaboration: Proven ability to build and manage strategic partnerships, cross-functional team leadership, stakeholder/client relationship management cultivating strong relationships with scientific experts, investigators, and industry partners. • Financial & Grant Management: Skilled in budget development/negotiation/management, resource allocation, grant/external funding life cycle management, and financial reporting/forecasting. •Scientific Expertise & Communication: Extensive experience in oncology research with deep understanding of cancer biology, biomarker identification, therapeutic strategies, and clinical trial design. Excellent communicator (English/Spanish), with scientific publications and peer-review experience, with the ability to effectively communicate complex scientific information to diverse audiences. • Adaptability: Proven ability to thrive in fast-paced environments adapting strategies in dynamic situations. Passionate about advancing innovative therapies to improve patient outcomes. Therapeutics Areas: oncology, immuno-oncology, radiation oncology, solid tumors, medical device.
• Led the strategic operational oversight of US oncology clinical programs, ensuring operational excellence and GCP compliance, including a multi-study MDACC Strategic Alliance, and a global multicenter Phase III clinical trial. • Collaborated with internal/external stakeholders to develop US clinical programs short- and long-term objectives. • Led the development and maintenance of key clinical trial documentation (e.g., study protocols, ICFs, CRFs, SOPs, TMF), ensuring regulatory/GCP adherence to be audit ready, and oversaw regulatory correspondence with external IRBs. • Managed a team of clinical operations personnel, providing training, supervision, and mentorship. • Selected and managed CROs, negotiating contracts and ensuring adherence to study timelines and budgets. • Developed US clinical program budgets and conducted long-range planning /forecasting activities. • Represented ARTIDIS at national conferences, actively engaging with the clinical research community.
• Managed Cell & Gene programs (e.g., oncology cell therapy) for process development/validation and tech transfer to GMP manufacture, including risks assessment and mitigation plans. • Served as the single point of contact for clients, developing strong relationships and managing their program portfolios. • Managed cross-functional teams to ensure projects execution, meeting milestones and deliverables. • Effectively managed project scope, timelines, budgets, and financial reporting/revenue forecasting to maintain business profitability. • Collaborate with the Sales/Commercial Development team to contribute to program strategies and to the Sales & Operations process.
• Acted as liaison with stakeholders and actively engaged in oral presentations (e.g., proposed studies, progress reports), effectively communicating complex scientific information. • Managed the development of strategic partnerships (e.g., multi studies strategic alliances) to build novel immuno-oncology clinical research initiatives for patients with advanced solid tumors, including pre-clinical to clinical phase transitions. • Designed clinical trial workflows and budgets, streamlining cost estimation and contract negotiations. • Led and managed the strategic clinical development of over five clinical studies (immunotherapy-radiation oncology Phase I, I/II, II). • Secured over $15M in executed strategic partnerships agreements and $20M pipeline under development, demonstrating successful negotiation, and relationship-building skills. Provided administrative leadership support and management. • Oversaw the preparation of compliance documents (e.g., study protocol, ICF, IBC, MTAs) and collaborated with cross-functional teams to manage complex oncology clinical trials. • Prepared successful internal and external translational/clinical grant proposals, securing $500K in funding to support research initiatives.
RESEARCH FOCUS: Role of viral and cellular non-coding RNAs in cancer malignancies, diseases and viral infections; Role of non-coding RNA in cancer aggressive progression; Role of HGF/cMET pathway in aggressive adrenal carcinoma. RESEARCH / MANAGEMENT, MENTORING / TRAINING / SUPERVISION & LEADERSHIP: • Led the design and management of multiple translational/clinical research projects and grants, resulting in timely execution of milestones, budget optimization, and high-quality data reported in peer-reviewed publications. • Successfully developed hypothesis-driven translational/clinical research experiments (circulating ncRNAs, sepsis, oncology, disease diagnostics/prognostics), pre-clinical in vivo models, and toxicology assessment. • Actively involved in biomarker strategy development, and establishment of laboratory SOPs to maintain research quality assurance. • Collaborated with clinicians for the development of oncology therapeutic strategies. • Responsible for regulatory compliance (e.g., IACUC, IRB, IBC, MTAs, IDRs) of ongoing research projects and clinical studies. • Supervised and mentored/trained 14 trainees and professionals. • Organized meetings and seminars, and actively engaged in Institutional (e.g., Faculty Senate, Faculty Academic Review Committee) and Departmental committees (e.g., Seminar Committee). SCIENTIFIC / GRANT WRITING & PRESENTATIONS: • Contributed to the successful preparation of 19 grant proposals (internal and external), securing funding for 2 R01s, an MDACC NCI Prostate Cancer SPORE CEP Award, a NIH Extramural LRP for Clinical Research, and 2 NCI scholarships. • Authored and collaborated on scientific manuscripts, and managed submission and revision processes for multiple publications. • Presented research findings at 11 local, national, and international meetings, including posters and oral presentations.
RESEARCH FOCUS: Role of obesity and Metabolic Syndrome on cancer aggressive progression RESEARCH / MANAGEMENT, MENTORING / TRAINING / SUPERVISION & LEADERSHIP: • Successfully managed a SG Komen grant KG081048 to study the impact of obesity and obesity treatments on breast cancer (2011-2013) within the proposed time and budget. Reported as several posters, oral presentations, and in a JNCI peer-reviewed publication. • Engaged in translational/clinical cancer research and coordinated with clinicians for the collection and processing of patients’ samples. • Performed wide-range molecular biology/genomics, biochemistry, pre-clinical in vivo models (e.g., transgenic, xenografts, orthotopic), molecular toxicology, tumor metabolisms approaches, and the integration of high-throughput screening analyses, and scientific data analysis and reporting. • Actively involved in laboratory operations/management, compliance, projects management, assay development, data analysis and reporting • Supervised and mentored/trained 15 trainees and professionals. • Postdoctoral Association Executive Committee: Chaired the Responsible Conduct of Research (RCR) Seminar Series Subcommittee (2012-2014) to fulfill the NIH guidelines for all trainees within our institution and neighbor institutions. Served in the Institutional Postdoctoral Advisory Committee. SCIENTIFIC / GRANT WRITING & PRESENTATIONS • Prepared clinical protocols in collaboration with physicians while managed compliance regulatory protocols (e.g., IACUC, IBC). • Awarded with a 3-years postdoctoral research fellowship for training in Molecular Genetics of Cancer at MD Anderson, a NIH Extramural Loan Repayment Program for Health Disparities Research, several travel and leadership awards, and NCI-funded scholarships. • Authored and collaborated on scientific manuscripts, and managed submission and revision processes for multiple publications. • Selected to give 17 poster and 5 oral presentations in local and national meetings.
RESEARCH / MANAGEMENT, MENTORING / TRAINING / SUPERVISION & LEADERSHIP: • Center for Environmental and Toxicological Research: Engaged in a wide-range molecular biology and biochemistry (e.g. DNA, RNA and protein analyses), environmental toxicology (air particulate matter) and molecular toxicology approaches, scientific data analysis and reporting. • Actively involved in lab management (e.g., budgeting, equipment/supplies purchasing, progress reports), successfully supported SOPs, grants and manuscript, ensuring external funding. • Supervised and trained/mentored 15+ trainees, including high school, undergraduate, graduate, medical students, a postdoctoral fellow, and visiting scientists. • Visiting Graduate Research Assistant at the Department of Medical Toxicology, University of Colorado Health Sciences Center (Summers 2003 & 2005). • Actively involved in several institutional, state and national societies leadership positions. • Participate as member of the Health Commission Special Committee, chaired by the Honorable Senator Luz Arce Ferrer, for the creation of a law projects for the establishment of Academic Medical Health Centers in Puerto Rico (Law No. 136, 2006). SCIENTIFIC / GRANT WRITING & PRESENTATIONS: • Awarded with a 5-years graduate student research fellowship, Minority Biomedical Research Support-Research Initiative for Scientific Enhancement (R25GM618838). Awarded with over 5 travel awards, and over 12 leadership and academic achievement awards. • Actively engaged in effectively communicating scientific data in local and national meetings. • Published one first-author and one first-author peer-reviewed manuscripts, and at least 18 abstracts/posters presentations. • Actively engaged in public speaking.
• Chaired and managed the Institutional Advisory Committee for the use of the Technology Fee ($150,000/year plus matching funds, 5 academic years), Dean Office for Academic Affairs. • Prepared and negotiated annually granted proposal to match funds to implement new strategies to cover the technological need on Campus to improve the education of the student community (School of Medicine, School of Dental Medicine, School of Pharmacy, School of Public Health, School of Nursing, and School of Health Professions).
• Graduate Biochemistry (BCHM 8500, sec. 100, 3 Credit; 3 students; 2008 Fall Semester), Master in Sciences (MS) – Biochemistry Graduate Program, Department of Biochemistry. • Medical Biochemistry (Teaching Assistantship/Discussion Leader, Small Group Discussions Component; 12-15 medical students; 2006-2008 Fall Semesters), Department of Biochemistry, School of Medicine. • Dental Biochemistry (Tutorial Lecturer: 20-25 1st Year dental students; 2006-2009 Fall Semesters), School of Dental Medicine.
• Actively engaged in the review and approval of new academic curriculums and academic programs (e.g., nursing doctoral degree), Faculty Promotions and Faculty Promotions Appeals, and other academic related systemic policies for the 11 Campuses. • Chaired the Permanent Student Affairs Committee (2006-2009) for the review and recommendation of proposals of services related to the student community and the improvement of their quality of life.
• Appointed by the President of the University of Puerto Rico (UPR) to serve in the Systemic Economics and Financial Institutional Advisory Committee to study the economy and UPR finance 1995-2005 to give recommendations to the Board of Reagents to implement new strategies for tuition fees, budget plans and policies. Related Publication: • Aponte JB, Vélez-Arocho JI, Fuentes-Mattei E, García-Palmieri MR, Valedón N, López A, Porrata-Doria Z, Cabán E., Estrada M, and Rivera A. Institutional Financial Advisory Committee Report. University of Puerto Rico, (2007).