Anne Rubin
Arvada,CO
Summary
Clinical research and operations professional with extensive experience in the biotech and pharmaceutical industry. Skilled in Good Clinical Practice (GCP), global clinical trial management (Phase I-IV), and clinical operations oversight. Proficient in program management, consistently achieving study milestones within budget and timelines through effective collaboration within the CRO and Pharmaceutical/Biotechnology model. Notable achievements include contributing to two successful NDA submissions, resulting in the introduction of new drugs for Type 2 Diabetes and Major Depressive Disorder. Led the Phase 3 team to obtain Emergency Use Approval for mRNA-1273, a COVID-19 vaccine.
Overview
31
31
years of professional experience
Work History
Director, Clinical Research, US Medical
Takeda Pharmaceuticals
01.2022 - 01.2024
- Provided operational expertise and strategic input on the development of Clinical Development Plans (CDP) supporting the clinical strategy for Phase 4 clinical and operational programs and o, focusing on Crohn's disease, Ulcerative Colitis and Rare disease
- Lead the program-level operational strategy and planning on assigned programs in close collaboration with our strategic partners and other vendors
- Performed program-level oversight of our strategic partners and other vendors to ensure the operational execution and delivery of the assigned clinical programs in compliance with quality standards (including ICH GCP, local regulations, and Takeda SOPs)
- Working with Global Program Management , Outsourcing Management, and Finance to ensure that budgets, enrollment, and gating are accurate
- Communicated program status, cost and risks to senior management
- Provided program and study-level direction to the strategic partners/preferred suppliers to develop study strategy operational plans including enrollment models and risk management strategy
- Worked with Procurement, QA & Legal to qualify new clinical vendors and manage vendors for the duration of a study
- Leveraged professional networks and industry knowledge to strengthen client relationships.
- Spearheaded innovative approaches to patient recruitment and study related activities (i.e. electronic ICF and data capture)
- Cultivated and strengthened lasting client relationships using strong issue resolution and dynamic communication skills
- Reported issues to higher management with great detail.
- Reduced operational risks while organizing data to forecast performance trends
Clinical Study Director
Exicure, Inc.
09.2021 - 12.2021
- Conducted Start Up activities for Phase I Rare Disease including; writing Protocol, ICF, Study Documents, setting up EDC, IWRS, eTMF and site selection
- Managed the identification, selection and contracting of vendors including creating Request for Proposal (RFPs) and coordinating bid defense meetings
- Generated a comprehensive and detailed study-specific timeline project plan and budget oversight
- The data read out from the Phase I study did not meet the statistical endpoints and therefore the program was canceled early
Clinical Operations Lead Consultant
Moderna
05.2020 - 09.2021
- Responsible for Project Management of Phase 3 vaccine study for Coronavirus (SARS-CoV-2) pandemic
- Successfully managed 99 sites; enrollment of 30K over a 3 month period that resulted in Emergency Use Approval for mRNA-1273 for COVID-19 vaccine
- Collaborated closely with the internal Moderna team, NIH and CRO to successfully plan and execute this study during a COVID-19 pandemic
- Worked with Internal team, NIH and CRO on recruitment strategy including study branding to ensure appropriate patients being with an emphasis on location, ethnicity and minorities to ensure US representation
- Chaired weekly Investigator Meeting teleconference with sites and FDA collaborators to guide sites on conduct of the study and provide updates and have open Q&A sessions
- Project Management activities include; Timelines and Budget Management, Client Relationship Management, gaining Internal & external Alignment, Resource Management, Communication Planning, Risk Management, Setting up Trial Master file and overseeing preparation for FDA Audit
- Vendor & CRO Management: Participated in vendor capability and proposals discussions for vendor selection
- Managed CRO vendor and other vendors, including; IRT, EDC, Electronic ICF, Smart phone application for study drug compliance and collection of Adverse events and central and specialty labs
- Managed and Mentored Clinical Trial Managers for the study by outlining scope of work and ensuring study activities are being achieved.
- Lead study close out activities and data cleaning for FDA regulatory submission
Director, Project Management
PPD
05.2016 - 04.2020
- Responsible for overseeing multiple studies/programs Phase I-IV in Cardiovascular/Metabolic and Rare Disease
- Served as a key contributor within the Business Development and Bids/Contracts team for proposal development and client presentations; focusing on strategy, resources, risk mitigation and solutions to challenges within studies
- Provided supervision, support, training and mentoring to project managers
- Represented the Project Management Department on cross functional work streams for Activation and Recruitment Optimization and Project Metrics Delivery
- The goal of these work streams is to streamline data sources, identify Key Project Indicators and Milestones for tracking and reporting internally and externally to the clients
- Worked with leadership in all functional areas on the continuous development/improvement of business processes to ensure that work is uniform, efficient and managed appropriately.
Global Clinical Program Manager
Takeda Global Research and Development
Deerfield, Illinois
12.2012 - 05.2016
- Delivered the operational plan for global projects across multiple therapeutic areas including Central Nervous system and Cardiovascular/Metabolic diseases
- Responsible for managing a large global team in completion of a diabetes cardiovascular outcome study with 5000 subjects, conducted in 60 countries with a study budget of $300 MM
- Participated in preparation for FDA Advisory Committee meeting for cognition claim for major depressive disorder compound and provided guidance to study managers and clinical trial associates in preparing for an FDA Inspection
- Led cross functional teams through a new process of early engagement with strategic CRO partnership during start-up of a Phase II Acute Schizophrenia inpatient trial
- Implemented AI technology for eCOA and ePro, Study drug compliance and adverse event reporting.
- Provided oversight for multiple post marketing studies including relapse prevention, severe hepatic, and pediatric for a recently approved compound for Major Depressive Disorder
Associate Clinical Program Manager
Takeda Global Research and Development
Deerfield, Illinois
09.2011 - 12.2012
- Managed a cross-functional team to conduct a global phase III major depressive disorder/cognition impairment study
- This study was part of sNDA for cognition claim within a newly marketed product for major depressive disorder
- Provided oversight for the study execution team conducting phase II global bipolar studies
- Participated in an NDA filing and FDA inspection for Major Depressive Disorder compound
- Through participation on global project teams, provided strategic clinical operations input into clinical development plans and other key global project team deliverables
- Managed relationships with Strategic Partners and vendors, including setting expectations, training, risk mitigation, and resourcing
- Supervised and mentored clinical operations personnel; overseeing their day-day activities to successfully execute individual studies
- Responsible for clinical program budgets (ranging from $20 MM to $150 MM.
Senior Study Manager
Takeda Global Research and Development
08.2010 - 09.2011
- Managed cross functional study execution team, CRO and vendors to successfully meet timelines for multiple Phase III diabetes studies for NDA Submission
- Responsible for writing study protocols and Informed Consents, ensuring compliance of SOPs and ICH guidelines were adhered to
- Provided clinical operations input to other important study activities: Site identification and selection, Enrollment modeling, Trial Master File, Monitoring plans, EDC / Case Report Form, Data review and database lock activities, Clinical Study Report
- Planned and presented at US, Europe and Latin America Investigator Meetings.
Trial Operations Manager
Takeda Global Research and Development
10.2008 - 08.2010
- Responsible for start-up of multiple studies within a phase III gout program
- Activities included: reviewing and providing operational input on multiple protocols, amendments, informed consent documents, vendor specifications as well as site selection and site activations
- Functioned as the primary contact with the Takeda clinical monitors for study-related training and guidance and communicate site-related issues for cardiovascular outcome study in patients with gout
- Planned and presented at US CRA training on multiple protocols for the Gout Program.
Senior Project Manager
Synageva BioPharma
01.2007 - 01.2008
- Managed a Phase I, multi-centered, oncology trial in the US and India
- Responsibilities included; oversight of multiple CRO and Vendors in clinical monitoring, data management, IVRS, and Central laboratory
- Conducted Protocol training at Site Initiation Visits in the US and India
- Successfully completed enrollment on time and delivered interim analyses data sets to the Data Monitoring Committee for Phase II decision making.
Senior Study Manager
Takeda Global Research and Development
01.2004 - 01.2007
- Managed Phase II-III global research studies for Rheumatoid Arthritis and Hyperlipidemia
- Managed CRO and vendors to oversee all study activities including; site monitoring, IVRS, data management and central laboratory activities
- Led data query process and review of tables and listings for database close and lock and collaborated with internal cross functional team to prepare Clinical Study Report for FDA submission.
Senior Clinical Research Associate
Abbott Laboratories
01.2001 - 01.2004
- Performed as Lead CRA for large multicenter global 1000 Subject HIV post marketing study
- Provided oversight for study activities for 15 Ex-US affiliate offices conducting HIV clinical research study
- Co-monitored U.S
- Sites to assure CRAs are monitoring in accordance with ICH/GCP Guidelines and internal SOPs and implemented enrollment and coordinate site incentive program for 1000 patient study.
Senior Clinical Research Associate
SEARLE, A Division of Pharmacia
01.1999 - 01.2001
- Responsible for large multicenter US Phase III Oncology Prevention Trial in conjunction with National Cancer Institute (NCI) and coordinating specimen submission and tracking for central pathology and tissue Bank
- Responsible for monitoring U.S
- Sites in accordance with ICH and GCP guidelines
- Developed enrollment plan and created site study documents for a 2000 subject oncology prevention study.
Protocol Coordinator
Northwestern University, Pediatric Oncology Group
01.1997 - 01.1999
- Conducted site visits to monitor progress of Oncology protocols for Midwest NCI and Cooperative Sites according to federal regulations (NCI and FDA)
- Presented and trained CRAs and Study Coordinators at the Bi-Annual NCI Cooperative Group meeting
- Prepared and wrote Protocols, Informed consents and study documents.
Study Coordinator
Evanston Hospital, Kellogg Cancer Care Center
01.1993 - 01.1997
- Managed all aspects of Oncology clinical research studies for NCI sponsored cooperative groups and pharmaceutical companies
- Responsible for patient recruitment, conducting subject protocol visits, completion of source documentation and CRFs, query resolution, and IRB submissions of protocols, and reporting SAEs
- Responsible for data entry for hospital-based breast tumor registry and generated reports for the Surgical/ Oncology group.
Education
B.S. Psychology -
University of Kansas
Skills
- Project Management
- Contract Negotiation
- Operations Management
- Staff Management
- Rules and regulations
- Legal and Regulatory Compliance
- Issues Resolution
- Cross-functional team leadership
- Contract and Vendor Management
- Financial Reporting
- Strategies and goals
- Program Management
- Business Development
Therapeutic Expertise
- Cardiovascular: Acute Coronary Syndrome, Coronary Artery Disease
- Endocrine/Metabolic: Crohn's Disease, Ulcerative s, Diabetes Mellitus type 1 and type 2, Non-Alcoholic Fatty Liver Disease (NAFLD), Gout, Lipid disorder, Glycogen Storage Disease Type 1a, Ornithine Transcarbamylase Deficiency (OTC), Hunter's Disease MPS-II
- Infectious Disease: Coronavirus (SARS-CoV-2), HIV
- Immunotherapy: Rheumatoid Arthritis
- Musculoskeletal: Diabetic Foot Ulcers
- Nervous System: Major Depressive Disorder, Bipolar, Acute Schizophrenia
- Oncology: Breast, Prostate, Colon, Hodgkin’s Lymphoma, Leukemia
- Pediatrics: Oncology, Diabetes Mellitus Type 2
Professional Training and Certifications
- CCRP Certified
- Trained in neuropsychological assessments for efficacy and safety measures for Major Depressive Disorder and Schizophrenia.
- Trained in diagnostic assessment of psychopathology and assessment of cognitive function in clinical populations
Timeline
Director, Clinical Research, US Medical
Takeda Pharmaceuticals
01.2022 - 01.2024
Clinical Study Director
Exicure, Inc.
09.2021 - 12.2021
Clinical Operations Lead Consultant
Moderna
05.2020 - 09.2021
Director, Project Management
PPD
05.2016 - 04.2020
Global Clinical Program Manager
Takeda Global Research and Development
12.2012 - 05.2016
Associate Clinical Program Manager
Takeda Global Research and Development
09.2011 - 12.2012
Senior Study Manager
Takeda Global Research and Development
08.2010 - 09.2011
Trial Operations Manager
Takeda Global Research and Development
10.2008 - 08.2010
Senior Project Manager
Synageva BioPharma
01.2007 - 01.2008
Senior Study Manager
Takeda Global Research and Development
01.2004 - 01.2007
Senior Clinical Research Associate
Abbott Laboratories
01.2001 - 01.2004
Senior Clinical Research Associate
SEARLE, A Division of Pharmacia
01.1999 - 01.2001
Protocol Coordinator
Northwestern University, Pediatric Oncology Group
01.1997 - 01.1999
Study Coordinator
Evanston Hospital, Kellogg Cancer Care Center
01.1993 - 01.1997
B.S. Psychology -
University of Kansas