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Natalia Jacob
Buenos Aires,Argentina
Summary
I am an experienced leader in oncology drug development with 14+ years as a clinical trialist. Rapid ascent to Global Clinical Indication Lead with two promotions in three years, reflecting outstanding performance and potential. Proven success across CROs and Pharma, driving programs from preclinical through launch, with expertise in GU, breast & gynecologic malignancies; Rare Diseases; immuno-oncology; monoclonal antibodies; ADC platforms; and cell & gene therapies. Integrates translational science, real-world evidence, and AI insights into competitive clinical development strategies. I have a track record in regulatory filings, cross-functional leadership, and strategic program governance. Above all, my passion for science-based clinical trials underscores my belief in their potential to effect transformative changes in human health. My career aspiration is to participate in projects with an impact on medical practice and patients within the health industry.
Results-oriented achiever with proven ability to exceed targets and drive success in fast-paced environments. Combines strategic thinking with hands-on experience to deliver impactful solutions and enhance organizational performance.
Overview
1
1
Certification
15
15
years of professional experience
Work History
Senior Medical Director • Global Clinical Lead
Merck KGaA – Global Clinical Development
Buenos Aires, Argentina & Darmstadt, Germany
07.2021 - Current
- Global Clinical Lead for Avelumab
- Clinical Lead in Ph1 to 3 in GU, CRC malignancies, Rare Diseases & Pediatric
- Drive development strategy, trial design, and execution; lifecycle management and regulatory support
- Drove development strategy, trial design, execution; supported lifecycle management and regulatory compliance
- Led IND/CTA submissions and CSR writing; coordinated regulatory activities across Rest of the World
- Managed product life cycle from development through market exit.
- Forged partnerships with global cooperative groups and key opinion leaders to enhance regional trial access
- Lead women-in-leadership initiatives within R&D; support corporate diversity objectives
Sr. Medical Director -Medical Unit
Covance
Buenos Aires, Argentina
12.2020 - 06.2021
- Led business development activities, including bid defenses and RFPs, collaborating with stakeholders to secure new partnerships.
- Oversaw regulatory submissions, ensuring compliance with industry standards and guidelines.
- Directed the evaluation of new drug candidates, enhancing decision-making processes for project feasibility.
- Directed the evaluation of new drug candidates, improving decision-making processes for project feasibility assessments.
Associate MD → Medical Director → Senior Director → Interim Head of Oncology→ Senior Director- Medical Services Oncology & Hematology
Quintiles-IQVIA
Buenos Aires, Argentina
10.2011 - 11.2020
- Led global medical strategy for multi-cohort Phase 1–3 studies, resulting in two regulatory approved indications in Merkel cell carcinoma and bladder cancer
- Directed global medical efforts for Bintrafusp Alfa program, overseeing large Phase 1-3 trials
- Global Medical Lead for large phase 1 trials in hematological malignancies. Daiichi Sankyo
- Coordinated regional medical activities for PACIFIC III trial in lung cancer, enhancing trial execution and collaboration with cross-functional teams
- Established relationships to enhance collaboration between medical teams and external partners between the medical team and Q Solutions
- Participated in the development of medical data review protocols co-developer process
Attending Oncologist
Instituto De Oncología Ángel H. Roffo,Swiss Medical Group and Hospital Universitario Tornu
Buenos Aires, Argentina
10.2015 - 12.2022
- Functioned as primary oncologist consultant and tumor board member, provided expert consultations and collaborated on complex cases at Swiss Medical Group, Buenos Aires. Argentina, 2015-2022
- Led tumor board meetings in thoracic oncology unit at Hospital Tornu, Buenos Aires,Argentina 2015-2017
- Clinical oncologist attending at Instituto de Oncología Ángel H. Roffo (IOAR), breast and gynecological malignancies, Buenos Aires, Argentina2015-2020
- Invited at my alma mater hospital (IOAR) to gain expertise in rare diseases and GU malignancies, Ad Honorem, Buenos Aires,Argentina 2021-2024
- Coordinated internal medicine ward, consulted on newly admitted oncology patients, and managed weekly on-call responsibilities, ensuring comprehensive patient care,Buenos Aires, Argentina 2014-2016
- Adapted quickly to fast-paced work environments to maintain efficiency.
Education
Storytelling - Oratoria y Storytelling
Universidad De San Andrés (UdeSA)
Buenos Aires, Argentina01-2025
Post-Graduate Certificate - Novel Clinical Trial Design in Translational Medicine
University of Cambridge Online
Cambridge, England01-2025
Master of Science - Clinical Pharmacology
Universidad Abierta Interamericana
Buenos Aires, Argentina01-2023
Ph.D. - Molecular Biology
Universidad De Buenos Aires
Buenos Aires,Argentina01-2020
Clinical Oncology Specialist - Clinical Oncology
Universidad Católica (UCA)
Buenos Aires, Argentina01-2015
Internal Medicine Specialist - Internal Medicine Specialist
Hospital Universitario Sanatorio Güemes
Buenos Aires, Argentina01-2011
M.D. - Medicine
Hospital Universitario Fundación Favaloro
Buenos Aires, Argentina01-2008
Bachelor of Science - Biochemistry
NDNU–Stanford University
Sunnyvale, CA01-2002
M.D. - Medicine
Universidad Maimonides
Buenos Aires,Argentina01-1997
Skills
- Clinical Decision Making
- Scientific Research
- Data-Driven Strategy
- Planning & Organization
- Problem-solving
- Scientific Communication
- Patient Advocacy
- Critical thinking
- Cross-functional Collaboration
- Interpersonal Skills
Accomplishments
- Rebuilt go-to-market and clinical development strategy, delivering double-digit revenue growth/market share gains in fragmented markets
- Co-led digital modernization and data strategy program, increasing trial efficiency and regulatory readiness
- Directed cross-functional teams across four regions; improved portfolio, and accelerated product launches from concept to market
- Delivered FDA and RoW regulatory submissions (IND/CTA to CSR); enhanced global alignment and inspection readiness
- Built and maintained strategic partnerships with global cooperative groups and key opinion leaders; expanded regional trial access
- Mentored clinical scientists, fostering leadership development and succession planning within R&D
Affiliations
- American Society of Clinical Oncology (ASCO)
- Asociación Argentina de Oncología Clínica (AAOC)
- Asociación Médica Argentina (AMA)
Certification
- Doctor of Medicine (MD), Fundación Favaloro Teaching Hospital, Argentina
- Internal Medicine Specialist, Sanatorio Guemes, Argentina
- Master of Science in Clinical Pharmacology, Argentina
- PhD (Tumoral Molecular Biology) candidate; pending thesis presentation, Argentina
- Certifications and ongoing education: clinical trial design, translational medicine, leadership programs
Languages
Spanish (native)
English (proficient)
Hebrew (fluent)
Interests
- Advocacy Campaigns
- Fundraising Events
Timeline
Senior Medical Director • Global Clinical Lead
Merck KGaA – Global Clinical Development
07.2021 - Current
Sr. Medical Director -Medical Unit
Covance
12.2020 - 06.2021
Attending Oncologist
Instituto De Oncología Ángel H. Roffo,Swiss Medical Group and Hospital Universitario Tornu
10.2015 - 12.2022
Associate MD → Medical Director → Senior Director → Interim Head of Oncology→ Senior Director- Medical Services Oncology & Hematology
Quintiles-IQVIA
10.2011 - 11.2020
Storytelling - Oratoria y Storytelling
Universidad De San Andrés (UdeSA)
Post-Graduate Certificate - Novel Clinical Trial Design in Translational Medicine
University of Cambridge Online
Master of Science - Clinical Pharmacology
Universidad Abierta Interamericana
Ph.D. - Molecular Biology
Universidad De Buenos Aires
Clinical Oncology Specialist - Clinical Oncology
Universidad Católica (UCA)
Internal Medicine Specialist - Internal Medicine Specialist
Hospital Universitario Sanatorio Güemes
M.D. - Medicine
Hospital Universitario Fundación Favaloro
Bachelor of Science - Biochemistry
NDNU–Stanford University
M.D. - Medicine
Universidad Maimonides
Core Competencies
- Global Clinical Development Strategy and Execution
- Translational Science, Real-World Evidence, AI-informed development
- Regulatory Submissions (IND/CTA, CSR, dossiers)
- Program Leadership, Portfolio Management, Business Acumen
- Cross-functional, Multi-region Leadership and Collaboration
- Biostatistics Literacy, Study Design & Statistical Planning
- Scientific Storytelling for Boards and Senior Stakeholders
- Data Governance, Medical Data Review, Data-Driven Decision Making
- Cooperative Groups & KOL Engagement; Trial Site Network Expansion
Leadership & Governance Activities
- Member, Joint Steering Committee (JSC) with external partners; strategy alignment with senior leadership
- Sponsor and representative for Women-in-Leadership initiatives (Argentina); patient-centered outreach and community engagement
- Tumor board leadership and medical education outreach in Argentina; ongoing clinical service and community health activities
Quotations
PubMed: https://pubmed.ncbi.nlm.nih.gov/?term=natalia+Jacob
Oral Presentations and Posters
- P. Grivas, B. Pérez Valderrama, M. Tsiatas, P. M.-H. Chang, M. Kim, L. Antonuzzo,S.-J. Shin, G. Gakis, N. Blais, S. H. Kim, J.-A. Arranz Arija, Y.-L. Su, F. Zagouri, M. Maruzzo, A. Schneider, K. Tyroller, J. Hoffman, N. Jacob, J. Hoffman-Censits (2026). Avelumab + sacituzumab govitecan vs avelumab monotherapy as first-line maintenance treatment for advanced urothelial carcinoma: Updated subgroup analyses of JAVELIN Bladder Medley based on metastatic sites. Abstract #4568. Presented at the ASCO Annual Meeting, May 29-June 2, 2026; Chicago, IL.
- S. Kopetz, R. Garcia-Carbonero, Sae-Won Han, I. Ismael Rodriguez-Rivera, JC. Ruffinelli Rodriguez, V.Boni, M.Vieito Villar, JJ Soto-Castillo, N.Jacob, K.Kato (2026). Precemtabart tocentecan (Precem-TcT) in combination with bevacizumab in patients with metastatic colorectal cancer (mCRC): results from the Phase 1 PROCEADE-CRC-01 study. Poster #006461. ESMO GI 2026.
- J. Hoffman-Censits, M. Tsiatas, P. M.-H. Chang, M. Kim, F. Zagouri, S.-J. Shin, S. H. Kim, Y.-L. Su, J.-A. Arranz Arija, J. P. Maroto Rey, L. Antonuzzo, M. Maruzzo, R. Tambaro, N. Blais, S. Rottey, G. Gakis, A. Schneider, K. Tyroller, N. Jacob, B. Perez Valderrama (2026). Avelumab in combination with other anticancer agents as first-line maintenance treatment for advanced urothelial carcinoma: primary analysis from the JAVELIN Bladder Medley phase 2 trial (2026). Abstract 739. Presented at the ASCO Genitourinary Cancers Symposium, February 26-28, 2026; San Francisco, CA.
- Hoffman-Censits, J., Tsiatas, M., Chang, P. M.-H., Kim, M., Antonuzzo, L., Shin, S. J., Gakis, G., Blais, N., Kim, S. H., Smith, A., Arranz Arija, J. A., Zagouri, F., Su, Y. L., Forget, F., Jacob, N., Valderrama, B. P. (2025). Avelumab + sacituzumab govitecan (SG) vs avelumab monotherapy as first-line maintenance treatment in patients with advanced urothelial carcinoma: Interim analysis from the JAVELIN Bladder Medley phase 2 trial. ASCO 2025. Conference abstract
- Aragon-Ching, J., Petrylak, D., Sridhar, S. S., Gupta, S., Grivas, P., Powles, T., Gurney, H., Jacob, N., Tyroller, K., Guenther, S., Bellmunt, J. (2024). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term outcomes from the JAVELIN Bladder 100 trial in patients with high BMI. Poster Abstract #600; Session: B, Urothelial Carcinoma. ASCO GU 2024. Conference abstract; poster.
- Grivas, P., Aragon-Ching, J. B., Bellmunt, J., Loriot, Y., Sridhar, S. S., Su, P.-J., Park, S. H., Yamamoto, Y., Jacob, N., Hoffman, J., Kearney, M., Schlichting, M., Powles, T. (2024). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term patient-reported outcomes (PROs) in the phase 3 JAVELIN Bladder 100 trial. Abstract #581; Session: B, Urothelial Carcinoma. ASCO 2024.
- B.Aragon-Ching,S.Gupta,P.Grivas,S.H.Park,D.P.Petrylak,S.S.Sridhar,H.Gurney,N.Jacob,K.Tyroller,J.Hoffman,J.Bellmunt (2026). Avelumab first-line maintenance for advanced urothelial carcinoma: long-term outcomes from the JAVELIN Bladder 100 trial in patients with high body mass index or diabetes mellitus.ESMO Open. https://doi.org/10.1016/j.esmoop.2026.107776
- Gupta, S., Sridhar, S. S., Powles, T., Bellmunt, J., Park, H., Gurney, J., Tsuchiya, N., Petrylak, D. P., Tomita, Y., di Pietro, A., Manitz, J., Tyroller, K., Hoffman, J., Jacob, N., Grivas, P. (2025). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term outcomes from the JAVELIN Bladder 100 trial in older patients. ESMO Open. https://doi.org/10.1016/j.esmoop.2025.104506
- Grivas, P., Aragon-Ching, J. B., Bellmunt, J., Loriot, Y., Sridhar, S. S., Su, P.-J., Park, S. H., Yamamoto, Y., Jacob, N., Hoffman, J., Kearney, M., Schlichting, M., Powles, T. (2024). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term analyses of patient-reported outcomes and quality-adjusted time without symptoms or toxicity (Q-TWiST) from the JAVELIN Bladder 100 trial. European Urology Oncology. https://doi.org/10.1016/j.euo.2025.04.004
- Bellmunt, J., Powles, T., Park, S. H., Voog, E., Valderrama, B. P., Gurney, H., Ullén, A., Loriot, Y., Sridhar, S. S., Tsuchiya, N., Sternberg, C. N., Aragon-Ching, J. B., Petrylak, D., Climent Duran, M. A., Tyroller, K., Hoffman, J., Jacob, N., Grivas, P. (2024). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term outcomes from JAVELIN Bladder 100 in patients with lower burden. Journal of Clinical Oncology. https://ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.4566
- Loriot, Y., Gupta, S., Powles, T., Grivas, P., Petrylak, D., Tyroller, K., Hoffman, J., Jacob, N., Bellmunt, J. (2024). Avelumab first-line maintenance for advanced urothelial carcinoma: Long-term outcomes from the JAVELIN Bladder 100 trial in patients with histological subtypes. Journal of Clinical Oncology. https://doi.org/10.1016/j.esmoop.2025.104506
- Hoffman-Censits, J., Grivas, P., Powles, T., Hawley, J., Tyroller, K., Seeberger, S., Guenther, S., Jacob, N., Tadjalli Mehr, K., Hahn, N. M. (2024). The JAVELIN Bladder Medley trial: Avelumab-based combinations as first-line maintenance in advanced urothelial carcinoma. Future Oncology. https://doi.org/10.2217/fon-2023-0492
- Reck, M., Barlesi, F., Yang, C.-H., Westeel, V., Felip, E., Özgüro, M., Cobo Dols, M., Sullivan, R., Kowalski, D. M., Andric, Z., Lee, D. H., Sezer, A., Hu, P., Wang, X., von Heydebreck, A., Jacob, N., Tadjalli Mehr, K., Park, K. (2023). Avelumab versus platinum-based doublet chemotherapy as first-line treatment for patients with high-expression PD-L1–positive metastatic NSCLC: Primary analysis from the phase 3 JAVELIN Lung 100 Trial. Journal of Thoracic Oncology, 18(9), 145. https://doi.org/10.1016/j.jtho.2023.09.1445
- Bitton, R., Jacob, N., Carrera, J. M., Perez, E. C. (2020). Comparative effectiveness of immune-checkpoint inhibitors as first-line treatment for advanced non-squamous non-small cell lung cancer: A network meta-analysis and a systematic review. Journal of Clinical Oncology, 38(15 suppl), e21731. https://doi.org/10.1200/JCO.2020.38.15_suppl.e21731
- Pautas en Oncologia 2018 IOAR (Pfizer-sponsored). Pautas en Oncologia 2018. ISBN 950-9421-18-9.
- Real-world comparisons of responses in HER2-positive breast cancer post-neoadjuvant therapy. Argentina real-world study; 2018.
- Seguridad cardíaca del tratamiento neoadyuvante con pertuzumab y trastuzumab en cáncer de mama HER2-positivas. Argentina real-world study; 2018.