Dr. Agnes Lteif has been appointed Senior Vice President and Head of U.S. Medical Affairs & Regulatory at Ipsen, effective September 2025. According to the industry range, she will oversee strategic initiatives across oncology and rare diseases in North America – A difficult position yet extremely honorable. Dr. Lteif joins the organization with an outstanding track record extending clinical medicine, strategic regulatory operations, and commercial leadership in oncology. She earned her M.D. from the American University of Beirut and holds an MBA, equipping her with a unique fusion of physician-perspective and business insight.
Most recently, Dr. Lteif served as Vice President and Head of Solid Tumors at Novartis Oncology U.S., where she led the launch of KISQALI® (ribociclib) in early breast cancer and strengthened its position in advanced disease. Before that, she held leadership roles across U.S. medical affairs and clinical development, driving evidence generation and medical-commercial alignment. In her new capacity at Ipsen, Dr. Lteif will oversee all U.S. medical affairs and regulatory functions, including scientific engagement, evidence-generation strategy, regulatory submissions, and alignment of medical affairs initiatives with broader organizational goals. She will collaborate closely with research & development, commercial operations, and external stakeholders to accelerate access to transformative therapies—particularly in oncology and related specialties.
“I am honored to assume this role at such a dynamic time in the life-science sector,” remarked Dr. Lteif.
“With rapidly evolving science, regulatory pathways, and patient expectations, I look forward to leveraging rigorous clinical insight, stakeholder collaboration, and patient-centric strategy to deliver meaningful impact,”
she writes on her LinkedIn page. Colleagues and industry observers alike note that Dr. Lteif’s dual background as a physician and business leader positions her as the perfect candidate to navigate today’s increasingly complex healthcare landscape. Her leadership is anticipated to reinforce Ipsen’s commitment to scientific excellence, regulatory integrity, and patient-focused innovation.
The U.S. Medical Affairs & Regulatory department at Ipsen plays a vital role in bridging scientific innovation, regulatory compliance, and patient-centered healthcare to ensure Ipsen’s products are developed, approved, and managed in line with the highest standards.
Medical Affairs is responsible for providing unbiased scientific communication and education to healthcare providers, supporting clinical research programs, managing medical information dissemination, and fostering collaborative relationships with key opinion leaders and patient advocacy groups. This function ensures that medical and scientific information about Ipsen’s products and diseases is accurate, transparent, and accessible, supporting safe and effective patient use.
The Regulatory Affairs component focuses on developing and implementing strategies to gain and maintain regulatory approvals for Ipsen’s products. This includes preparing regulatory submissions, managing interactions with authorities like the FDA, and ensuring compliance with laws governing advertising, promotion, and product safety. Regulatory teams also oversee pharmacovigilance activities—monitoring drug safety post-approval and rapidly reporting adverse events.
At Ipsen, the Medical Affairs & Regulatory teams work closely with cross-functional colleagues—from clinical development to commercial—to align product lifecycle management, uphold quality standards, and ensure ethical conduct in interactions with healthcare professionals and payers. They are also responsible for navigating the complex landscape of U.S. healthcare regulations to facilitate timely patient access to innovative therapies.
Dr. Agnes Lteif – Career Milestones
• Earned M.D. from American University of Beirut.
• Holds an MBA
• Served as Vice President & Head of Solid Tumors, Novartis Oncology U.S. (led KISQALI® launch)
• Appointed Senior Vice President & Head of U.S. Medical Affairs & Regulatory for North America, Ipsen
• Recognized among “100 Influential Women in Oncology: Key Opinion Leaders to Follow in 2025”.
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Looking Ahead
So what holds in the future? In her new role, Dr. Lteif will take on the strategic alignment of medical affairs and regulatory functions within the U.S. Her work will include advancing clinical evidence generation and strengthening collaborations with patients, payers, and doctors. Her role is central to Ipsen’s continued compliance and engagement in the complex and ever-changing world of medicine. The therapeutic landscape will continue to evolve with precision medicine, adaptive trial designs, and new regulatory paradigms.
Please join us at OncoDaily in congratulating Dr. Agnes Lteif on this well-deserved appointment and in welcoming her to Ipsen as she embarks on this exciting new chapter!
Written by Hasti Donyagardrad , MD