About Julie Rosenberg MD
Senior Life Sciences Consultant
Julie Rosenberg, MD is a senior life sciences consultant with an exceptional track record of success leading global drug development and pharmacovigilance programs. As a highly skilled pediatric hematologist-oncologist and seasoned business leader, she partners with biopharma companies—from innovative biotech startups to well-established enterprises—to tackle complex challenges in clinical development, trial design, operational efficiency, and regulatory strategy.
With extensive experience in clinical development, drug safety and pharmacovigilance, Dr. Rosenberg excels in crafting and executing comprehensive strategies that drive successful outcomes.
Her tactical expertise spans medical monitoring, data review, protocol development, single-case and aggregate safety review and the creation of clinical study reports. Leveraging her deep understanding of global regulatory landscapes, including interactions with the FDA, EMA, and other regulatory authorities, she provides strategic insights that help to streamline approval processes.
A graduate of the University of Missouri–Kansas City School of Medicine, Dr. Rosenberg completed her Pediatrics residency and Pediatric Hematology-Oncology fellowship at Baylor College of Medicine and then served as faculty at University of Texas Southwestern Medical School prior to transitioning her career to Biopharma. Based in Florida with her family, she continues to provide cutting-edge drug development advisory and consulting services to the life sciences industry.
Experience
Career Highlights
Dr. Rosenberg’s career includes significant consulting experience through BioBridges and leadership roles at top pharmaceutical companies:
Pfizer
As Global Asset Leader for Oncology Biosimilars, she led cross-functional teams to design and execute full development plans for rituximab, bevacizumab and trastuzumab biosimilar programs, successfully navigating global submissions and regulatory interactions.
- She also worked internationally with global teams, including in China, to implement oncology biosimilars programs.
Bayer
In her role as Global Clinical Leader, she oversaw key development programs for prostate cancer and multiple myeloma, ensuring seamless integration of clinical, operational and regulatory strategies.
Bristol-Myers Squibb
As Director of Oncology Global Clinical Research, she led innovative clinical initiatives for cutting-edge cancer treatments.
Boehringer Ingelheim
As Associate Director of Global Pharmacovigilance, she established cancer treatments, supported development of a Pediatric Center of Excellence, and managed safety monitoring systems, ensuring robust pharmacovigilance frameworks.
Dr. Rosenberg’s extensive background in medical oversight and her roles as a trusted pharmaceutical executive make her a critical resource for biopharma organizations navigating the complexities of clinical development and regulatory requirements. She also offers specialized expertise as a pharmacovigilance consultant.
Leadership
A Proven Leader
As a consultant, Dr. Rosenberg has served in many capacities, including as a Chief Medical Officer where she provided critical guidance and oversight across all phases of the drug development lifecycle, from molecule inception to regulatory approvals and post-marketing commitments.
When organizations face strategic challenges and lack the internal resources or expertise to meet ambitious goals, Dr. Rosenberg is a trusted advisor and problem-solver. With comprehensive industry knowledge, executive acumen, and proven ability to align cross-functional teams, she is able to solve the intricate issues that arise in clinical development, regulatory strategy, and pharmacovigilance.
Beyond her professional achievements, Dr. Rosenberg is an invited member of Marshall Goldsmith’s ‘MG’ 100—a distinguished group of leading consultants, coaches, and entrepreneurs—and the International Women’s Forum, an exclusive network of influential female leaders.
Quick Links
Julie Rosenberg, MD is a senior life sciences consultant with a proven track record of success in leading global drug development and pharmacovigilance programs.
Contact Details
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