Michelle O'Neal, PhD
Talented And Successful Nuclear Medicine And Theranostics Professional With Proven Track Record In Clinical, Commercial, Investigational, Medical Affairs.
Hillsborough,NC
Summary
Versatile Nuclear Medicine and Theranostics subject matter expert with over twenty-two years of combined clinical, commercial and medical affairs, investigational drug, product pre-launch, content development, education, and people management experience. Experienced in investigational new drug clinical trials from First in Human through Expanded Access.
Experienced in providing regulatory responses to FDA queries during initial and updated label submissions. Deeply collaborated with Prostate brand marketers during Pluvicto pre-launch activities to develop content for customer-facing roles, meet with key opinion leaders as subject matter expert, and serve as internal educator on how to conduct nuclear capability assessments and enable sites to treat.
Highly adept and mature people leader who has led new and established teams through several significant team expansions and numerous organizational changes with transparency, reassurance, and grace.
Ability to educate and communicate highly scientific medical and technical language such as principles and concepts of nuclear medicine and radioactivity into easy-to-understand concepts tailored to the target audience.
Overview
20
20
years of professional experience
10
10
years of post-secondary education
Work History
Radioligand Therapy Manager, US Field Medical
Novartis Pharmaceuticals, Innovative Medicines, US
2 2019 - Current
- National field-medical role responsible for leadership and development of subject matter experts tasked with engaging in bi-directional scientific exchanges with medical providers, prescribers and clinical staff on the nuances and intricacies of targeted RLT therapy; GI NET and Prostate
- Serve as internal subject matter expert to regional brand marketing directors during pre-launch activities
- Content development and evolution of the nuclear capbility and enablement onboarding tools throughout the different iterations of the RLT organization - 2019 to current
- Content development of internal and customer-facing assets focused on operationalization of Lutathera Administration Guide, Pluvicto RLT platform, Dosing & Administration Guide, Dose Calibrator Instruction Guide
- Collaborated with Prostate brand regional markets to meet with key opinion leaders during pre-launch to discuss interest in product, potential or known obstacles to adoption, and viable solutions to nuclear capability challenges.
- Respond to on-label and off-label inquiries on infusion methods
- Provide guidance to and collaborate with Novartis TCO Clinical Operations to clearly articulate and clarify RLT infusion methods, rates and nuances as it pertains dose escalation and patient safety/efficacy during phase I First-In-Human.
- Building, maintaining and managing effective professional peer-peer relationships with contracted External Experts (EE), or Key Opinion Leaders (KOL) through bi-directional scientific/educational exchange
- Provide education on disease state, mechanism of action and infusion of radiolabeled targeted therapies
- Develop and nurture robust relationships with treatment sites and authorized users
- Educate RLT treatment sites on how to operationalize the platform within their existing infrastructure - initial site visit/RAML approval through first patient infusions and beyond. Review, approval and upload of RAML to ROME system
- Successfully recruit, hire, train and develop RTSs to be SMEs for their respective territories in regard to recruitment, hiring, onboarding, establishing performance standards, professional development, merit raises, expense reporting
- Scalability - aligned hiring to expand RTS team with AAA/Novartis corporate plans to align with market demands
- Reputation as an efficient and effective cross-functional collaborator on projects, regulatory issues and questions with internal AAA/Novartis, stateside and globally; Patient Ready Dose initiative, ROME project, Indianapolis manufacturing plant, FDA label responses, assisting other countries with trouble-shooting infusion methods or clinical trial infusion instructions.
- External cross-functional collaborations with Nuclear Pharmacists, Authorized Users and Radiation Safety officers as needed to assist with identification of root cause of ongoing issue(s) and viable solutions for rising RLT patient volumes that account for department workflow, existing patient throughput, existing department infrastructure
- Share experiential knowledge and insights with executive leadership on the nuances of different therapeutical radiopharmaceuticals and inherent physical characteristics that signal potential challenges in treatment site expansion strategies
- Collaborate with Novartis regulatory professionals as SME to respond to FDA comments during initial label submissions and updates
- Backfill RTS territory vacancies and gaps in site onboarding coverage during times of high volume to ensure treatment sites receive the education and support needed
Regional Director, Radioligand Therapy, East
Novartis Pharmaceuticals
04.2024 - Current
- Serves as senior content and nuclear capabilities expert for the internal RTS team, internal Novartis partners and external customers.
- Integral in the development of several On-Demand customer-facing education tools to efficiently and effectively address education needs during the Patient-Ready Dose initiative.
- Content development of RTS Nuclear Capabilities Assessment Checklist (New Commercial Sites), RTS Nuclear Capabilities Assessment Checklist - Investigational/Clinical Trial Sites
- Developed and gained approval to reactively share Third-Party Radioactive Waste Vendor, Amino-Acid Vendors, and Reclaimed Vendors for Contaminated and Non-Contaminated Lead
- Accountable to RTS team performance in new RLT site nuclear capability assessments of present infrastructure and providing feedback to site on Novartis RAM product enablement from concept through effectuation of the RLT platform; RAML initial license and amendment process, review/approval of existing RAML, procurement, preparation, handling, administration, and disposal of RAM as aligned by ALARA and applicable NUREGs and USP 797/825.
- Development of process algorithms for commercial and investigational drug and clinical trial site Novartis RAM product enablement - site initiation visits, treatment site feasibility, equipment QA/QC, phantom imaging and upload for site validation, simplifying pharmacy manual and protocol language for clinical staff to develop actionable protocols and workflow for successful trial site.
- Responsible for the regulatory, fiscal, and administrative oversight of the RTS team in the Eastern US region
- Collaborates with Sr Director of Nuclear Capabilities & Education to develop strategic plan of operations, allocation of resources and coverage, and setting individual and team goals and initiatives.
- Spearhead and collaborate with internal cross-functional partners on strategic RLT initiatives and projects
- Develop and implement meaningful metrics tool(s) to assess the productivity and impact of the RTS team
- Identify unmet educational needs internally and externally the RTS teams' capabilities and skillsets could be leveraged to fill the need or knowledge gap
Chief Technologist; Nuclear Medicine & PET
Duke University Medical Center
09.2016 - 02.2019
- Responsible for the clinical, personnel and fiscal operations management of 3 imaging departments, 35 FTEs and 14 imaging systems contributing in excess of $110M to radiology revenue (2018)
- Oversight clinical and investigational protocols for large academic research medical center with eight gamma, four SPECT/CT, and two PET/CT imaging systems diagnostic quality capabilities
- Oversight of both standard of care and investigational general nuclear medicine and nuclear cardiology protocols; 8 therapeutic (clinical), 150-plus diagnostic (clinical) and 15 investigational therapeutic and 21 diagnostic protocols.
- Oversight of 29 clinical and 33 investigational PET protocols
- Outstanding track record of cross-functional collaboration with Nuclear Pharmacists, Nuclear Medicine physicians and principle investigators with site initiation visits, feasibility assessments and publications
- Key personnel on several investigator led trials - clinical trial coordinator and regulatory coordinator Expanded Access Prototol-Compassionate Care protocol to provide Lutathera to patients with gastroenteropancreatic neuroendocrine cancer (GEPNETs)
- Research protocol startups - Initial and updated Investigational Review Board (IRB) submissions informed consent writing, Investigation New Drug/Device submission to FDA, adverse event reporting to Duke IRB and sponsor(s), FDA interactions and collaboration with sponsors and vendors
- Formal preceptor for nuclear medicine technology students from Pitt Community College completing rotations at Duke Hospital
- Served as cross-functional collaborator on projects with disciples across the Duke Health System organization; construction of two brand new state of the art departments, integration of two separate nuclear medicine departments into one (general nuclear medicine and nuclear cardiology), and two reorganizations.
Assistant Chief Technologist; Nuclear Medicine
Duke University Medical Center
09.2014 - 09.2016
- Responsible for daily clinical operations of dynamic nuclear medicine and nuclear cardiology department within a large academic research center
- Responsible for both standard of care (SOC) and research imaging protocols
- Evaluated new imaging sequence protocols and processes and executed prescribed nuclear medicine procedures.
- Provided new employees with training and ongoing guidance on organizational procedures, policies and best practices
- Foster positive and constructive relationships between faculty and staff
Senior Nuclear Medicine Technologist
Duke University Medical Center
01.2005 - 09.2014
- Provided new employees with training and ongoing guidance on organizational procedures, policies and best practices.
- Developed and implemented improved diagnostic standards for inpatient and outpatient exams in alignment with department goals.
- Produced diagnostic images for use in identification and treatment of diseases by applying and measuring radioactive isotopes.
- Captured images using mobile equipment in operating rooms, emergency rooms and patients' bedsides.
- Reviewed physicians' orders to determine medical imaging needs and operated radiologic equipment to capture, develop and produce diagnostic images.
- Utilized computer data to develop information and process images for interpretation.
- Calibrated and prepared radioactivity and radiopharmaceuticals to administer to patients.
- Explained procedures to patients and families and answered questions to ease anxiety and encourage patient cooperation.
- Practiced safe testing methods by limiting radiation exposure to patients and personnel.
- Resolved problems, improved operations and provided exceptional service
- Led projects and analyzed data to identify opportunities for improvement
Education
Ph.D. - Education And Leadership in Healthcare
Nebraska Methodist College of Nursing And Allied Health
Omaha, NE 06.2018 - 07.2020
MBA -
Pfeiffer University
Misenheimer, NC 08.2016 - 12.2017
MHA/MSL - Science of Leadership
Pfeiffer University
Misenheimer, NC 08.2013 - 08.2016
Bachelor of Science - Health Care Management
University of Mount Olive
Mount Olive, NC 08.2011 - 08.2013
Associate of Science - Nuclear Medicine Technology
Pitt Community College
Winterville, NC 06.2004 - 08.2005
Skills
Nuclear Medicine and Radiopharmaceutical SME
Scientific medical research experience - RLT products
Outstanding Knowledge and Presentation Skills on GI NET Disease State and RLT Landscape
Proficient Knowledge and Presentation Skills on Prostate Cancer Disease State and RLT Landscape
Expert Knowledge of RLT Infusion Techniques
Exceptional leadership, networking, collaboration and communication skills
Ability to manage competing priorities and work across different functions
Ability to identify and remove barriers and increase efficiencies
Cross-Functional Collaboration
Nuclear Regulatory Commission - CRF 35300, 35395
Highly proficient in national, state and local policies and guidelines pertaining to radioactive material and intended use
Timeline
Regional Director, Radioligand Therapy, East
Novartis Pharmaceuticals
04.2024 - Current
Ph.D. - Education And Leadership in Healthcare
Nebraska Methodist College of Nursing And Allied Health
06.2018 - 07.2020
Chief Technologist; Nuclear Medicine & PET
Duke University Medical Center
09.2016 - 02.2019
MBA -
Pfeiffer University
08.2016 - 12.2017
Assistant Chief Technologist; Nuclear Medicine
Duke University Medical Center
09.2014 - 09.2016
MHA/MSL - Science of Leadership
Pfeiffer University
08.2013 - 08.2016
Bachelor of Science - Health Care Management
University of Mount Olive
08.2011 - 08.2013
Senior Nuclear Medicine Technologist
Duke University Medical Center
01.2005 - 09.2014
Associate of Science - Nuclear Medicine Technology
Pitt Community College
06.2004 - 08.2005
Radioligand Therapy Manager, US Field Medical
Novartis Pharmaceuticals, Innovative Medicines, US
2 2019 - Current
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