Shubhda Roy is a distinguished leader in NGS cancer diagnostics, biotechnology, and healthcare innovation, with over 20 years of experience in product management, clinical trials, AI-driven automation, and regulatory compliance. As Associate Program/Product Director at QIAGEN, she spearheads agile product development strategies, CRM optimization, and data-driven decision-making to drive groundbreaking advancements in cancer diagnostics. Her career spans top biotech and pharmaceutical firms, including Fabric Genomics, Guardant Health, Bristol-Myers Squibb, and Siemens Healthineers, where she has led high-impact projects, launched transformative products, and navigated complex regulatory landscapes.
Shubhda’s ability to translate scientific insights into market-ready solutions is exemplified by her success in launching a somatic product that unlocked a $4.1 billion market opportunity at Fabric Genomics. She also streamlined AI-driven somatic curation services, reducing turnaround time from days to under 24 hours, thereby enhancing efficiency, accuracy, and scalability in cancer diagnostics. At Guardant Health, she led the launch of Guardant Reveal MRD, a $15 billion biopharma opportunity, demonstrating her proficiency in end-to-end product strategy, regulatory alignment, and cross-functional collaboration.
Her strategic foresight extends beyond product launches—she excels in business development, software integration, and AI-driven decision support systems. While at Bristol-Myers Squibb, Shubhda played a key role in technology surveillance, vendor evaluation, and digital innovation for antibody engineering, establishing enterprise-level platforms that optimized biologic R&D, translational medicine, and clinical trials. Her ability to bridge scientific research and commercial execution positions her as a visionary leader in biotech innovation.
Beyond product innovation, Shubhda is a recognized expert in agile methodologies, project management, and stakeholder engagement. With 35 endorsements in Agile methodologies, 20 in Agile project management, and 24 in requirements analysis, she has built high-performing teams that align regulatory, operational, and market demands. She has effectively orchestrated multi-disciplinary teams spanning clinical operations, bioinformatics, regulatory affairs, finance, and marketing, ensuring seamless execution of complex healthcare initiatives.
Shubhda’s global perspective enhances her ability to adapt and scale solutions across international markets. Having worked extensively across India, Germany, Japan, Europe, South America, and other global markets, she understands the intricacies of regional regulatory requirements, market access, and scientific advancements. Her multilingual proficiency in English and Hindi further strengthens her capability to collaborate across diverse global teams.
Education has been a cornerstone of Shubhda’s career. She holds two Master’s degrees—one in Biotechnology (Molecular Targets & Cancer) from Johns Hopkins University and another in Computer and Information Sciences from Penn State University. She is currently pursuing a Master’s in Stem Cell Regenerative Medicine, further deepening her expertise in cutting-edge biomedical advancements. Additionally, she has earned certifications from Harvard University in Gene Therapy and CRISPR: Gene-Editing Applications, equipping her with advanced knowledge in genetic engineering, precision medicine, and next-generation therapeutics. Her combined expertise in computational sciences and biotechnology positions her uniquely at the intersection of AI-driven healthcare and scientific innovation.
Committed to mentorship, education, and community impact, Shubhda actively contributes to the Navanritya Dance Academy, where she has helped raise over $100,000 for charity through Indian classical dance performances. She is also a member of the Ray of Hope International Foundation, a global nonprofit supporting underprivileged children and families in the USA and India. Her dedication to arts, culture, and philanthropy reflects her well-rounded approach to leadership—balancing scientific excellence with social responsibility.
In addition to her corporate leadership, Shubhda has engaged in academic research and innovation projects. Her work in cell-to-cell signaling, preterm birth prevention, and biotechnology commercialization demonstrates her ability to apply scientific research to real-world healthcare challenges. She has developed FDA-compliant site inspection plans, led mock audits, and crafted regulatory SOPs to support the clinical development of drugs and biologics.
At the heart of her career is a guiding philosophy: “Be the Light.” Whether pioneering new technologies, mentoring future leaders, or advocating for global health equity, Shubhda embodies this ethos—illuminating paths forward in science, innovation, and human impact.
Shubhda’s unique blend of scientific acumen, computational expertise, strategic insight, and leadership excellence makes her an invaluable asset to biotech, pharma, and diagnostics companies seeking to drive innovation, optimize operations, and bring life-saving products to market. Her passion for data-driven decision-making, AI-powered healthcare solutions, and cross-functional collaboration sets her apart as a transformational leader in healthcare innovation.
With a track record of launching multi-billion-dollar innovations, streamlining AI-powered diagnostics, and fostering global collaboration, Shubhda Roy is poised to shape the future of precision medicine, regenerative therapies, and next-generation healthcare solutions.
Character:
Shubhda Roy is a resilient and ethical leader who drives healthcare innovation with integrity, commitment, and purpose. Her dedication to scientific excellence and social impact ensures that her work positively influences both business success and patient outcomes.
Knowledge:
With deep expertise in NGS cancer diagnostics, regenerative medicine, AI-driven automation, and clinical trials, Shubhda transforms cutting-edge research into impactful healthcare solutions. Her advanced education from Johns Hopkins and Harvard, combined with hands-on experience in biopharma, diagnostics, and precision medicine, makes her a thought leader in biotechnology innovation.
Strategic Thinking:
Shubhda excels in business development, regulatory strategy, and product commercialization, ensuring biotech solutions achieve market success and long-term scalability. She leverages agile methodologies, global experience, and stakeholder collaboration to align scientific advancements with business growth in highly regulated environments.
Communication:
Her ability to translate complex scientific concepts into actionable business strategies makes her a highly effective communicator across executive, scientific, and regulatory teams. She fosters cross-functional alignment, builds strong partnerships, and drives global collaboration, ensuring seamless execution of high-impact healthcare initiatives.
