Boaz Hirshberg

Boaz Hirshberg

Senior Vice President, Clinical Development Unit Head, Internal Medicine @ Regeneron

About

Regeneron: Senior Vice President, Clinical Sciences, Internal Medicine at Regeneron | Physician-Scientist & Global Drug Development Leader | Obesity • Cardiovascular Renal Metabolic (CVRM) • Ophthalmology •Immunology • Infectious • Rare Diseases Global clinical development leader uniting science, strategy, and execution to advance transformative medicines. ABOUT Physician-scientist and global biopharmaceutical executive with a proven record of leading early and late-stage clinical development, shaping strategic vision and direction across multiple therapeutic areas. As Senior Vice President, Clinical Sciences – Internal Medicine at Regeneron, I oversee a diverse portfolio spanning Obesity, cardiovascular and metabolic, ophthalmology, immunology, inflammation, infectious, and rare diseases. I bring more than 20 years of industry experience integrating scientific excellence with operational execution. Prior to Regeneron, I served as Clinical Therapeutic Area Head, Cardiovascular, Renal, and Metabolic Disease at MedImmune (global biologics arm of AstraZeneca), accountable for early clinical development and governance oversight, and as Head of Clinical Development at BOLpharma, where I was part of the senior management team. An endocrinologist and internist, I have authored over 125 peer-reviewed publications, led global programs including the 16,500-patient SAVOR cardiovascular outcomes trial, and contributed to multiple successful NDA and sNDA submissions. My experience encompasses FDA, EMA, PMDA and NMPA interactions, global regulatory strategy, and alliance management with academia, biotech, and large pharmaceutical partners I am passionate about translating science into meaningful therapies, fostering cross-functional collaboration, and developing future leaders who will shape the next era of innovation in medicine.

Country

United States

City

Tarrytown

Industry

Biotechnology

Skill

Medicine, Endocrinology, Internal Medicine, Clinical Research, Clinical Trials, Biotechnology, Clinical Development, Diabetes, Drug Development, GCP, Medical Affairs, Pharmaceutics, Pharmacology, Pharmacovigilance, Translational Medicine, Pharmaceutical Industry, Communication, Teamwork, Diversity & Inclusion, Professional Communication

Experience

Regeneron

Senior Vice President, Clinical Development Unit Head, Internal Medicine

Regeneron

LinkedIn
2023-10 - Present · 3 yrs

Tarrytown, New York, United States

Senior Vice President, Clinical Development Unit Head, Internal Medicine. Leading strategic program direction as well as early and late stage clinical development for a broad range of therapeutic areas including Obesity, ophthalmology, Immunology, inflammation, infectious, cardiovascular, metabolic and rare diseases.

Regeneron

Senior Vice President, Clinical Sciences General Medicine

Regeneron

LinkedIn
2021-3 - 2023-10 · 2 yrs 8 mos

Tarrytown, New York, United States

Senior Vice President, Clinical Sciences General Medicine, leading strategic program direction and late-stage clinical development for a broad range of therapeutic areas including ophthalmology, cardiovascular and metabolic, pain and neurology, and infectious and rare diseases.

BOL Pharma

Chief Medical Officer

BOL Pharma

LinkedIn
2019-6 - 2021-3 · 1 yr 10 mos

Revadim, Israel

Title: Head of Clinical Development | Member, Executive Leadership Team Summary: Directed all aspects of clinical development strategy and execution across the company’s portfolio of novel therapeutics. Served on the senior executive team, contributing to corporate clinical research strategy, portfolio prioritization, and external partnerships. Key Achievements: • Established and led the global clinical development function, integrating medical, regulatory, and operational components. • Oversaw clinical program design, regulatory submissions, and cross-functional governance. • Evaluated and integrated external licensing and partnership opportunities across academia Impact: Built a high-performing clinical organization from the ground up and guided several programs through critical milestones.

MedImmune

Vice President, Clinical Therapeutic Area Head Cardiovascular Renal and Metabolism (CVRM)

MedImmune

LinkedIn
2015-6 - 2019-6 · 4 yrs 1 mo

Gaithersburg, Maryland, United States

Vice President, Clinical Therapeutic Area Head, Cardiovascular Renal and Metabolism (CVRM) at MedImmune, the biotech arm of the AstraZeneca. Accountable for all early clinical development plans and clinical trials within CVRM; chairing the CVRM Clinical Functional Review Committee (FRC) and Protocol Review Committee (PRC), respectively; serving as core member of the MedImmune Safety Review Board (MSRB). Visionary leader, committed to bringing scientific innovation to early and late clinical trials, currently focused patient centricity and on the use of digital technologies and AI to expand data sets and improve the patient experience. Key Achievements: * Defined and executed integrated early development strategy from candidate selection through Phase 2 * Directed multiple global programs in diabetes, dyslipidemia, and renal/metabolic diseases * Partnered with research, regulatory, and commercial functions to ensure seamless advancement from early to late-stage development. * Drove portfolio governance and cross-functional decision-making across R&D. Impact: Advanced MedImmune’s CVRM portfolio through early clinical success and efficient program transitions to late-stage development, positioning the organization for long-term therapeutic leadership in metabolic disease.

AstraZeneca

Executive Director

AstraZeneca

LinkedIn
2013-12 - 2015-6 · 1 yr 7 mos

Wilmington, Delaware, United States

Served as Global Clinical Lead for the saxagliptin (Onglyza) franchise, guiding its life-cycle management and post-approval studies. In partnership with BMS, led the Qtern (dapagliflozin/saxagliptin) development and NDA submission. Qtern was approved by the the EU in July 2016 and FDA in February 2017 as a once-daily treatment for type 2 diabetes, Qtern is a combination medication containing dapagliflozin, an SGLT2 inhibitor, and saxagliptin, a DPP-4 inhibitor. Its development followed the approval of the individual components

AstraZeneca

Senior Director

AstraZeneca

LinkedIn
2010-12 - 2013-12 · 3 yrs 1 mo

Wilmington, Delaware, United States

Senior Director, Clinical Research Led global programs including the $250M, 16,500-patient SAVOR cardiovascular outcomes trial, and contributed to multiple successful NDA and sNDA submissions.

AstraZeneca

Director

AstraZeneca

LinkedIn
2007-11 - 2010-12 · 3 yrs 2 mos

Wilmington, Delaware, United States

Clinical research in diabetes, cardiovascular outcome study, Study lead for the SAVOR outcome study as well as several additional phase 3 studies. Member of the team developing Komboglyze: medication that combines two different drugs—saxagliptin and metformin In partnership with Abbott, served as clinician for the development of a combination including Crestor (rosuvastatin), a statin for lowering LDL cholesterol, and Abbott's fenofibrate or next-generation fenofibrate (ABT-335) to manage triglycerides and HDL ("good") cholesterol.

Pfizer

Associate Director

Pfizer

LinkedIn
2004-9 - 2007-11 · 3 yrs 3 mos

Groton, Connecticut, United States

Early clinical lead, diabetes

The National Institutes of Health

Staff Clinician

The National Institutes of Health

LinkedIn
2002-7 - 2004-9 · 2 yrs 3 mos

Bethesda, Maryland, United States

The National Institutes of Health

Endocrine Fellowship

The National Institutes of Health

LinkedIn
1999-6 - 2002-6 · 3 yrs 1 mo

Bethesda, Maryland, United States

Endocrine Fellowship, NIDDK, NIH

Hadassah Medical Center

Internal Medicine Hospitalist

Hadassah Medical Center

LinkedIn
1999-1 - 1999-6 · 6 mos

Jerusalem, Israel

Hadassah Medical Center

Internal Medicine Resident

Hadassah Medical Center

LinkedIn
1995-1 - 1998-12 · 4 yrs

Jerusalem Area, Israel

Education

The Hebrew University of Jerusalem

The Hebrew University of Jerusalem

LinkedIn

Internal Medicine Residency Program

1995 - 1999 · 4 yrs

Hadassah Medical Center, Ein Karem, Israel

The Hebrew University of Jerusalem

The Hebrew University of Jerusalem

LinkedIn

Medicine

1987 - 1994 · 7 yrs

Medical School

Boaz Hirshberg's Contact Information

Email

******@***.com

Phone

(**) *** ****

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