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Accomplished leader in global scientific affairs and medical diagnostics, with over twenty years of experience in advancing diagnostic strategies and shaping impactful programs in rare diseases, including bone and cardiology conditions, Duchenne muscular dystrophy, hemophilia, lysosomal storage disorders, metabolic disorders, neurodevelopmental disorders, neuromuscular diseases, and oncology.Known for establishing and executing scientific and medical affairs strategies leading from within Medical Affairs at the junction of Clinical Development and Commercial. Guide cross-functional collaborations, education and strategy, facilitating successful biomarker and diagnostic strategy integration into clinical programs, product launches and product lifecycles. Medical Affairs interface skills include: Developing and leading innovative sponsored genetic and biochemical testing programs, digital health solutions and data-driven insights to streamline diagnostic journeys and accelerate patient access to innovative therapies. Partnering closely with functions within Commercial, ClinDev and Medical Affairs as well as within R&D and IT. Spearheading initiatives that build both internal and external capacity through scientific education, medical and scientific communication. Advancing cutting-edge testing methodologies, and developing strategic frameworks for molecular and biochemical diagnostics. Supporting scientific and policy advancement of newborn screening in the US and globally.Commercial interface skills include:Advancing patient find and identification efforts through improved diagnostic testing and biomarker strategy integration into commercial launch programs led compliantly from within Medical Affairs. Developing and presenting field training and education to support best customer service engagement around medical diagnostics.Clinical Development Science interface skills include:Leading lab developed test and companion diagnostic test development and commercialization to support clinical programs and commercial programs. Advising on Regulatory diagnostics strategy for test use in studies. Understanding of clinical trial assay use and risk for commercial requirement or risk for an IVD and/or CDx. Supporting biomarker and diagnostics studies in US, EU and Japan. Understanding of FDA Rule and In vitro diagnostics regulation in EU (IVDR).
Ultragenyx Pharmaceutical Inc.
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Molecular DiagnosticsUltragenyx Pharmaceutical Inc. 2019 - PresentNovato, California, UsAs the leader of Molecular Diagnostics within Global Medical Affairs, I drive strategic functional planning to optimize product lifecycle management and support new product launches. My work is centered on advancing molecular and biochemical diagnostic practices, with a focus on rare diseases and newborn screening. I’m dedicated to promoting global diagnostic algorithms that ensure accurate and efficient diagnosis.Analyze emerging technologies, medical devices, and business opportunities to deliver best-in-class diagnostics for rare diseases. Manage multiyear lifecycle programs, budgets and scientific alliances, collaborating across disciplines. I oversee the development of gene locus-specific databases, a vital tool for improving diagnostic precision: www.rarediseasefgenes.comSome key achievements in my role include:• Authoring critical sections for Health Authority meetings (US, EU, Japan) and supporting BLA filings• Supporting the launch and readiness of nine drug programs across five disease franchise areas: Bone/Endocrine, Cardiology, Metabolic, Neuromuscular, and Ultrarare, with extensive experience across the US, Europe, Latin America, Asia and the Middle East• Championing Newborn Screening (NBS) initiatives in collaboration with internal and external business partners to drive strategic goals• Leading a team developing diagnostic devices, including laboratory-developed tests (LDTs) and companion diagnostics (CDx), overseeing bioanalytical development, technology transfer, and regulatory compliance• Crafting strategies for communication, publications, and congress presentations • Pioneering biochemical-genetic testing research to enhance diagnostic accuracy and result interpretation• Supporting regulatory strategy co-development and addressing FDA queries on diagnostic programs and medical devices• Implementing data analytics and health record analysis solutions to advance rare disease diagnosis
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Executive Director, Head Of Scientific AffairsBiomarin Pharmaceutical Inc. 2018 - 2019San Rafael, Ca, UsSet strategic goals and diagnostic plans to drive product lifecycle management and guide successful new product launches. Key responsibilities included managing a multidisciplinary newborn screening team, collaborating closely with Government Affairs, Market Access, Marketing, and Medical Affairs to align efforts and achieve impactful outcomes. Established a comprehensive communication plan for Scientific Affairs, complemented by a publication and congress strategy to strengthen our presence in the field.Coordinated and oversaw contracted scientific research, including the development of essential reagents and materials, and facilitated global scientific summits focused on advancing laboratory- and clinically-based diagnostics for rare disease patients. Experience spans various therapeutic areas—rare metabolic diseases, neurology, hemophilia, and oncology.Some key achievements for this role include:• Partnering with cross-disciplinary teams to develop diagnostic resources for laboratory and medical communities• Leading research and innovation in biochemical-genetic testing methods, particularly in test result interpretation• Preparing diagnostic subject matter for presentations to FDA Advisory Committees• Developing interactive learning and development tools for healthcare professionals, medical science liaisons, and clinical and sales teams• Leading the conception of DOVE, a digital diagnostic interface for Duchenne (DMD), available at https://www.dmd.nl/DOVE/This work bridged scientific research with real-world diagnostic applications, bringing diagnostic solutions to healthcare professionals and contributing to improved patient outcomes in rare and complex diseases. -
Senior Director Scientific Affairs, Global Medical AffairsBiomarin Pharmaceutical Inc. 2015 - 2018San Rafael, Ca, Us
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Director Scientific Affairs, Global Medical AffairsBiomarin Pharmaceutical Inc. 2012 - 2015San Rafael, Ca, Us
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Associate Director Scientific Affairs, Global Medical AffairsBiomarin Pharmaceutical Inc. 2010 - 2012San Rafael, Ca, Us
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Research Scientist Through Director – Molecular Pharmacology And Clinical DevelopmentExelixis 2000 - 2010Alameda, California, UsHad the privilege to lead scientific teams dedicated to oncology discovery and development. Directed efforts to develop and analyze clinical pharmacodynamic biomarkers, driving impactful research outcomes. Experience spans from the full discovery and development of candidate projects to managing cross-functional programs. Authored multiple IND documents, including leading a Discovery through Phase I program on mTOR.Oversaw research initiatives focused on identifying oncogene mutations tied to drug resistance, enhancing understanding of key therapeutic challenges in oncology. Served as a field scientific liaison for investigational products, presenting mechanisms of action and scientific insights to stakeholders.Key contributions:• Coordinating oncology pre-clinical teams, aligning project goals, and timelines, and optimizing assay workflows to achieve targeted outcomes• Leading research for and drafting of IND submissions for eight independent small molecule programs, directly supporting drug development pipelines• Heading a Clinical Operations team in support of Phase II and Phase III programs.• Developing an innovative On-Site Blood Donor for Research Program, used in pre-clinical and clinical biomarker studies to advance scientific insights and applications.This experience reinforced my commitment to bringing meaningful innovations from the lab to clinical practice.
Nicole Miller Skills
Nicole Miller Education Details
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University Of California, San FranciscoBiochemistry -
University Of California, DavisGenetics
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University Of Wisconsin-MadisonOncology
Frequently Asked Questions about Nicole Miller
What company does Nicole Miller work for?
Nicole Miller works for Ultragenyx Pharmaceutical Inc.
What is Nicole Miller's role at the current company?
Nicole Miller's current role is Medical Diagnostics & Medical Affairs Executive | Driving Innovation in Global Diagnostics and Medical Affairs for Rare Disease Solutions.
What is Nicole Miller's email address?
Nicole Miller's email address is jn****@****ail.com
What is Nicole Miller's direct phone number?
Nicole Miller's direct phone number is (866) 906*****
What schools did Nicole Miller attend?
Nicole Miller attended University Of California, San Francisco, University Of California, Davis, University Of Wisconsin-Madison.
What are some of Nicole Miller's interests?
Nicole Miller has interest in Environment, Children, Education.
What skills is Nicole Miller known for?
Nicole Miller has skills like Drug Discovery, Biotechnology, Drug Development, Clinical Development, Oncology, Translational Medicine, Pharmaceutical Industry, Life Sciences, Assay Development, Biomarkers, Cancer, Cell.
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