Claudia Moore, M.Sc. Email and Phone Number
Whether I’m developing clinical strategies, working with patient advocacy groups, listening to physician needs, managing complex global projects, or overseeing vendors, my focus remains the same: How can we make this work better for the patients we serve and the teams we support? I’m the go-to Clinical Operations leader for mission-critical projects that demand a passion for patient engagement. Working closely with rare disease communities taught me that patient success and successful product adoption depends on building strong relationships with key opinion leaders, understanding the patient journey, and creating support systems that address real patient needs. Through this patient-centric approach, i've led frameworks that increased patient participation across multiple rare disease trials while driving operational excellence. I've led the clinical portion of presentations that secured board approval for clinical programs worth up to $195 million, while simultaneously driving $37 million in early vendor negotiation savings. My expertise spans clinical strategy development, patient advocacy engagement, end-to-end clinical project management, people management, and vendor oversight. I have a history of de-risking medical product development from early innovation through market approval. By fostering relationships with key stakeholders, patient advocacy organizations, and physicians, I have enabled the successful delivery of clinical projects globally for complex pharmaceuticals and medical devices. My expertise lies in accelerating medical product development by enabling clinical project teams to become decision-makers, leveraging data to support decision-making, embracing synergies from diverse expertise, and rapidly adapting workflows for optimal efficiency. Reporting to the Senior VP of Clinical Development and Operations, I successfully managed a global clinical program focused on investigating a small molecule treatment for Spinocerebellar Ataxia 3, Amyotrophic Lateral Sclerosis, and Huntington's disease. I partnered with key stakeholders to identify patient population needs and leveraged data to drive adaptation to decentralized models. These efforts increased patient access and participation by 90%. In my previous roles at Thermo Fisher Scientific, Edwards Lifesciences, and Medtronic, I have consistently demonstrated my ability to lead cross-functional teams, mentor direct reports, drive innovation, and successfully manage multiple projects and priorities in fast-paced and highly matrix environments.
Dianthus Therapeutics, Inc.
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Director, Clinical OperationsDianthus Therapeutics, Inc. Jun 2024 - PresentNew York City, New York, Us -
Associate Director, Clinical Operations And DevelopmentSeelos Therapeutics, Inc. Jul 2021 - May 2024New York, New York, UsDevelop timelines, budgets, and protocols for global neurological and rare disease clinical programs for a small molecule with indications for Spinocerebellar Ataxia 3 (SCA3), Amyotrophic Lateral Sclerosis (ALS), and Huntington’s Disease (HD). Key responsibilities and contributions include:• Developing patient-centered clinical strategies. • Partnering with advocacy groups to incorporate the patient voice into clinical trial designs and leveraging vendors to boost patient-centricity and engagement. • Selecting CROs and Vendors• Hiring and managing clinical operations personnel • Empowering teams to implement trials with a sense of urgency. • Leading meetings to foster collaboration across functional subject-matter experts.• Contributing to regulatory submissions and presentations• Serving as a point of escalation for clinical project managers and holding meetings with vendors as needed to drive results. -
Global Clinical Team Manager - Covid-19 VaccinesPpd Feb 2021 - Jul 2021Wilmington, Nc, UsI led a team of regional Clinical Team Managers, Clinical Research Associates, and Research Coordinators to drive consistency across COVID-19 vaccine trials. My key responsibilities and contributions included:• Partnering with cross-functional leads to identify risks and innovative mitigations.• Owning clinical deliverables at a global level ensuring timelines, resources, and quality were maintained.• Providing project-specific training and leadership to the clinical team to achieve project goals and maintain motivation.• Leading clinical team meetings to track progress to clinical deliverables, set priorities for the team, implement mitigations, and address team needs. -
Manager, Clinical Project ManagementEdwards Lifesciences Dec 2018 - Jan 2021Irvine, Ca, Us• Partnered with the R&D and Clinical Specialist teams to address safety and efficacy issues prior to moving into pivotal trials. • Provided project-specific training to the clinical operations team to implement clinical strategy and achieve project milestones.• Collaborated with functional managers to develop and execute program plans, tools, key trial documents, and CRFs.• Owned clinical portions of regulatory submissions and partnered with regulatory affairs to address FDA inquiries. • Analyzed data and metrics to proactively identify risks and implement mitigations.• Led cross-functional meetings to track progress to clinical deliverables, set priorities for the teams, implement mitigations, and address team needs. -
Regulatory Operations Program ManagerFred Hutch Dec 2017 - Dec 2018Seattle, Wa, UsI was responsible for hiring, training, and managing four regulatory operations associates to support regulatory submissions and audits. I performed this role in parallel to my consultancy role with Medtronic. -
Clinical Research Project ManagerMedtronic Brain And Spine Therapies Dec 2014 - Jun 2018I executed high-priority cross-functional clinical projects to successfully gain and expand clinical indications for class III endovascular stents for the treatment of brain aneurysms. I started as the lead CRA and was promoted to the position of Clinical Project Manager after successfully serving as the acting Clinical Project Manager from May 2015 to Aug 2015. My key responsibilities and contributions included: • Mentoring and providing project-specific training to CRAs• Developing clinical study reports and owning the clinical portions of IDE and PMA submissions• Collaborating with the regulatory affairs team to address FDA inquiries. • Incorporating process improvements into a clinical project that contributed to the closure of corrective and preventative actions (CAPAs) from a prior for-cause audit. • Collaborating with functional managers to develop project plans, key trial documents, and CRFs.• Leading cross-functional meetings and clinical team meetings to track progress to overall project deliverables, set priorities for teams, implement mitigations, and address team needs. • Presenting project status and updates to Senior Management on a quarterly basis• Leading gap analysis and process improvement initiatives to support change management and integration with Medtronic. I transitioned to a part-time consultancy role starting in Dec 2017 which allowed me to relocate to the Seattle area and complete the Master of Science program at the University of Washington. -
Clinical Research Associate IiMirabilis Medica, Inc. Jun 2013 - Nov 2014Managed a local non-interventional study and an international feasibility/pilot device study focused on the treatment of uterine fibroids. Partnered with the Director of Clinical Affairs to create SOPs, policies, forms, and work instructions to help establish a Clinical Department for Mirabilis.
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Clinical Research Associate IMirabilis Medica, Inc. May 2011 - Jun 2013Monitored an interventional feasibility/pilot device study focused on women’s health. Drafted clinical documentation, managed vendors, and supported international regulatory submissions.
Claudia Moore, M.Sc. Education Details
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University Of WashingtonBiomedical Regulatory Affairs -
University Of WashingtonGeneral
Frequently Asked Questions about Claudia Moore, M.Sc.
What company does Claudia Moore, M.Sc. work for?
Claudia Moore, M.Sc. works for Dianthus Therapeutics, Inc.
What is Claudia Moore, M.Sc.'s role at the current company?
Claudia Moore, M.Sc.'s current role is Clinical operations leader with a knack for turning complex challenges into high-impact successes | Creating a community dedicated to delivering better outcomes to patients, physicians, and teams.
What schools did Claudia Moore, M.Sc. attend?
Claudia Moore, M.Sc. attended University Of Washington, University Of Washington.
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