Paul Mccracken

Lead global imaging strategy to accelerate innovative drug development across oncology, neuroscience, cardiovascular, renal, and immunology. Drive integration of AI/ML-derived imaging biomarkers and advanced analytics into clinical trials, enabling precision medicine and proof-of-concept outcomes. Collaborate with cross-functional teams—clinical, data science, and commercial—to optimize imaging platforms, harmonize data, and shape enterprise imaging policies. Oversee global partnerships and internal initiatives to advance imaging data repositories and novel biomarker discovery. Manage industry leading team and represent Novartis as a thought leader in imaging and translational medicine.

At RadiaNova, we fuse innovation, precision, and deep industry expertise to support pharma, biotech, and CROs in navigating the complexities of imaging, biomarkers, and clinical development. We specialize in: 🔹 Imaging Strategy and Solutions for clinical trials 🔹 Theranostics/Radioligand Therapy Development insights 🔹 Decision-making Biomarker Implementation 🔹 Operational Excellence in clinical imaging workflows Our expertise spans multiple therapeutic areas, including: 🧠 Neurology – Brain imaging and neurodegenerative disease research 🫁 Oncology – Cancer imaging, radioligand therapies, and biomarker-driven trials ❤️ Cardiometabolic – Body composition, Musculoskeletal, Liver, and Cardiovascular imaging for diagnosis and therapeutic monitoring 🧬 Rare Diseases – Precision imaging and biomarker integration for complex conditions Whether you're developing next-gen radioligand therapies, integrating imaging biomarkers into trials, or optimizing imaging operations, RadiaNova Consulting is here to guide your innovation.

Serve as a key strategic advisor to Voximetry, providing executive-level guidance on product strategy, clinical integration, and partnerships, while supporting the advancement of dosimetry solutions within radiopharmaceutical development and regulatory-aligned clinical workflows.

As part of Executive Leadership team, provide operational and strategic oversight of clinical and pharmaceutical trial services to grow top line revenue. Drive utilization of personalized dosimetry in radiopharmaceutical therapy.

Chosen to lead strategic evaluation of current and future state of client needs with respect to scientific, medical, technology, and innovation resources and capabilities. Executive Sponsor and primary business liaison for onsite visits from clients, auditors, FDA, EMEA, and CROs. 🔹 Led team of 50 PhDs, MDs, programmers, and analysts in development of new approaches and technologies. 🔹 Developed and executed plan for new operational and read technology platform, theranostics, radiation dosimetry, and machine learning / artificial intelligence (ML/AI). Secured agreements with two large pharma firms with focus on radiopharmaceuticals. 🔹 Directed business operations, including process improvement, CapEx, staffing, resource utilization, and project profitability, and oversaw site’s business continuity preparedness. 🔹 Represented ICON to seven key accounts (Top 10 global Pharma companies), including relationship management and scientific excellence. 🔹 Partnered with HR and facilities to promote positive workplace culture and employee engagement.

Provided global strategic leadership for third largest provider of imaging and cardiac safety clinical trials (Ph I-IV) to secure drug, radiotherapy, and device approvals (i.e., medical & scientific affairs, business operations, project / image / vendor / reader / data, medical writing, site operations, core lab, eTMF, quality, audit support). 🔹 Led planning, oversight, and management of multi-million global P&L with nine direct reports and 500+ headcount with focus on sales, year-over-year revenue, and profitability growth. 🔹 Provided operational, profitability, scientific / medical, and market position due diligence for acquisition of Biotel Research spinoff from Phillips in October 2023. Led business integration efforts for Biotel that increased ICON imaging by 50% and added Cardiac Safety Solutions to product portfolio, doubling team size. 🔹 Oversaw portfolio of 450+ clinical trials spanning neurodegeneration, oncology, theranostics / radiotherapy, cardiovascular, metabolic, musculoskeletal, and rare diseases with at least eight receiving FDA approval. 🔹 As part of comprehensive business assessment, identified operational efficiencies, cost reductions, automation opportunities, and productivity improvements. Globalized workforce and introduced machine learning. Improved departmental gross margin by 20%; grew headcount, sales, and revenue by up to 100%. 🔹 Guided technology-driven strategy, operational planning, product development, and execution. Consolidated and redirected technology to deliver best-in-class, innovative imaging / cardiac software (image analysis, radiomics, AI/ML, modeling). Improved clinical protocols timelines and administration by integrating AI/ML. 🔹 Led relationship management and negotiation for partnerships with sponsors and vendors. Provided biomarker scientific and business strategy to align with needs of Central and Specialty Laboratories. Accelerated advancement in digital pathology.

Andover Product Creation Innovation Systems • Global Head of Imaging, providing strategic leadership in discovery and translational programs across all therapeutic programs • Appointed by CEO to co-develop new site organizational structure and research strategy resulting in single site drug discovery unit delivering novel immuno-dementia and immuno-oncology therapeutics from human genetics • Andover Site Core Leadership Team, responsible for all strategic and research decisions • Initiate new target-based programs and technology platforms (PET Tracer Accelerator, Imaging Genomics) • Build and develop collaborations • Interim head of discovery and translational biomarkers, managerial oversite of solid tissue analysis, biofluid analysis, flow cytometry and molecular analysis

Biomarkers and Personalized Medicine Unit: Provide scientific and managerial leadership of the new Preclinical Imaging Group at Eisai • Establish newly formed preclinical imaging unit, including recruitment and introduction of imaging equipment; • Contribute to the high level management, strategic planning and scientific decision making; • Educate newly recruited and existing scientists/researchers; • Integrate and demonstrate capabilities of PET, SPECT, Optical, MRI and CT to drug development; • Establish key collaborations with industry and academic partners

Develop preclinical and translational imaging biomarkers/strategies for assessment of efficacy and safety of newly developed molecular and biologic entities. Experienced with MRI applied to osteoporosis, toxicological assessment, oncology (DCE-MRI), atherosclerosis, vascular injury, neuroscience (phMRI), respiratory (hyperpolarized helium), and diabetes (body composition/liver MRS). HR-pQCT/QCT/DEXA expertise for preclinical/clinical evaluation of bone/muscle therapies Participated in the planning and execution of several clinical imaging studies. This included collaborating with Contract Research Organizations and clinical colleagues on protocol design, quality control/quality assurance planning and documentation, data management, analysis methodology, evaluating site capabilities, and choosing appropriate imaging modalities and endpoints. Recruited key opinion leaders to become host sites for Phase I MRI studies. I have made significant contributions to the study of hr-pQCT/QCT/DXA/ finite element modeling for the evaluation of Phase III osteoporosis therapies.

Thesis: Magnetic Resonance Elastography of the Brain: Material Properties and Traumatic Brain Injury Modeling Digital Signal Processing • MRI • Advanced Image Processing • High Speed Signal Processing • Neural Networks • Ultrasonography • Radiation Oncology Physics • Biostatistics • Neuroscience • Molecular Biophysics • Radiation Dosimetry • C Programming

Thesis: Accuracy of the Dixon Methods for Fat and Water Quantification in NMR Imaging Classical Electrodynamics • Physiology • Human Anatomy • Medical Physics • Medical Imaging • Computed Tomography • Radiation Biology • Radiation Therapy • Principles of NMR • Health Physics