Vincent Amoruccio - Professional Experience

Experience

Praxis Precision Medicines | Boston, MA 08/2024-Present
Vice President, Head of Data Sciences
A clinical-stage biopharmaceutical company translating insights from genetic epilepsies into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance.

C-Suite Collaboration & Operational Leadership: Lead internal statistical, programming, data management, analytics and visualization activities related to clinical development, including clinical study designs, statistical analysis plans, data management plans, and enterprise analytics needs. Support regulatory meetings, submissions, and follow-ups. Partner with executive management on the strategy and content for key communications regarding clinical operations and results.

Clinical Development: Devise and innovate statistical approaches to design studies and the analysis/reporting of study results.

Cross-Functional Collaboration: Coordinate achievement of major statistical deliverables and milestones in collaboration with the clinical development team and other functions.

Team Leadership: Lead and manage internal and external biostatistics, statistical programming, and data management resources, as well as supporting studies and programs as needed.

Strategic Partnerships & Business Development: Collaborate with key industry stakeholders to enhance drug development initiatives and leverage strategic alliances.

Regulatory Strategy & Compliance: Support FDA, EMA, and global regulatory submissions through expert statistical guidance and rigorous adherence to regulatory standards.

SpringWorks Therapeutics | Stamford, CT / Durham, NC (R&D Headquarters) 11/2021-08/2024
Vice President, Head of Biometrics
A commercial-stage biopharmaceutical company that re-prioritizes promising science and pioneers efficient pathways for drug development for patients with severe rare diseases and cancer.

Clinical Development: Provided clinical and statistical input into the design of protocols, statistical analysis plans, and study reports, and ensured statistical integrity of presentations and publications of clinical studies by applying past experiences.
C-Suite Collaboration & Operational Leadership: Established and implemented a vision for the company's biometrics activities for all projects in clinical development. Partnered with executive management on the strategy and content for key communications regarding clinical operations and results.
Business Scaling: Optimized statistical, programming, and data management processes for efficiency and scalability.
Strategic Planning & Cross-functional Collaboration: Defined and implemented a cross-functional data science strategy in alignment with senior leadership. Collaborated with key industry stakeholders to enhance drug development initiatives and leveraged strategic alliances.
Team Leadership: Built and developed an expert team of experts in advanced analytic techniques, including Statisticians, Programmers, and Data Managers experts, to support goals across programs.
Development: Identified and delivered solutions that address key messages through statistical modeling to collaborate with Clinical Development and Medical Affairs projects. Stay current on cutting-edge approaches and tools.
Project Management: Interacted with CROs and functional service providers in managing Biometrics deliverables, including database setup, initiation, conduct, and closure of studies towards data reporting, analysis, and regulatory filings.
Resource Management: Managed functional resource allocation; assigned functional resources for each project based on the scope of services in the proposal/contract. Supervised to ensure timely and quality service delivery and provide guidance and support to the functional representative on each project as needed.
Deal Structuring: Negotiated contracts and overseeing budget management for insourced and outsourced operations.
Regulatory Knowledge & Compliance: Led statistical input for clinical trial design, analysis, and reporting, ensuring adherence to FDA, EMA, and other regulatory standards.

Pfizer | New York, NY / Groton, CT (R&D Headquarters) 6/2017–11/2021
Senior Director, Statistical Programming & Analysis, Rare Disease, Biosimilars, & Hospital Medicine
Largest pharmaceutical and global leader in biopharmaceutical industry. Responsible for a team of 150+ statistical analysts.

Clinical Research: Facilitate clinical research and deliver regulatory documents to support new drug applications and biological license applications in multiple therapeutic areas, including non-traditional, exploratory analyses and company-specific metrics.
Clinical Data Subject Matter Expert: Serve as SME on Clinical Data Integration Standards Consortium (CDISC) required by US, EUR, JPN, and other countries. Involved with submission decisions. Serve as health authorities’ point person. Maintain knowledge of systems and processes, patient-reported outcome data, and clinical trial data and structures.
Regulations: Ensured compliance with FDA requirement that drug approval submissions comply with CDISC. Educated executive management and major functions on significance and role of CDISC standard. Worked with leadership to evaluate current submissions and devise resubmission strategy: redo or hybrid submission. Met regularly with FDA.
Development: Oversee broad portfolio across all therapeutic areas and end-to-end biometric and data management functions of drug development.
Team Leadership: Recruited to lead, coordinate, and direct global programming teams ranging from 20-100 people. Ensure accurate, consistent, and quality deliverables. Meet timeline milestones.
Operational Leadership: Led transition from 30% to 70% insourced clinical trial support, opened India site and acted as interim head. Visited 5 times to meet site heads and HR, help select new site, establish the culture, and build a group with a top-down approach.
Data Management: Manage ad hoc analysis, data explorations, data curation, data analytics, and due diligence activities. Build and maintain structured data warehouses and metadata repositories. Developed schemas to normalize and integrate clinical trial data into structured repositories. Facilitated the reengineering of the Metadata Repository, resulting in enhanced utilization and reducing software development cycle times.
Data Sharing: Served as a critical stakeholder in a broad, multi-company initiative, Accumulus, to improve speed, transparency, and efficiencies in the regulatory process by leveraging advanced technology and tools for data exchange.
Data Governance: Serve on the data governance committee, helping to develop a tool that will emulate a data lake of clinical trial data to mitigate challenges and create efficiencies with regulatory submissions.
Industry Trends: Leverage up-to-date knowledge of data-technology standards, industry trends, and emerging technologies. Contributing to the transition from SAS to R and Python. Help Pfizer move to a more innovative computational software by adopting TransCelerate's framework for Modernization of Analytics.
Emerging Technologies: Sponsor and co-lead a proof-of-concept (PoC) for Machine Learning into a standard process that reduces human interventions and creates efficiencies. Collaborating with stakeholders to influence organizational change management.
Resource Management: Improved onboarding experience by working with business admins to create a dynamic SharePoint list to organize data. New tracker rolled out to the larger organization. In 2019, all manual processes were replaced by SharePoint. Developed metrics and dashboard.
Automation/Operational Efficiencies: Transformed US and China insourcing using SharePoint to automate 95% of the hiring process. The new process increased efficiency and transparency, currently under consideration by other functions.

Team Leadership: Created “Intern to Hire” graduate student program that yielded 18 hires in 1st 2 years. Drafted proposal and recruited 35 volunteers in PA, CT, and MA for a 10-week program offered through Boston University, Villanova, and UCONN.

Alexion Pharmaceuticals, Inc. | New Haven, CT 2008–6/2017
Senior Director, Global Head of Statistical Programming
Global biopharmaceutical company focused on rare diseases. 3K staff in 50 countries. Responsible for a team of 200+ clinical and statistical analysts.

Leadership: Served in increasingly more senior-level positions during tenure; promoted 4 times.
Operational Efficiencies: Developed and reviewed operating procedures. Brought company into 100% compliance by uncovering and addressing SOP issues, automating processes, and rewriting SOPs. Consulted on clinical and statistical programming.
Budgeting: Managed $15M budget. Forecasted expenses.
External Leadership: Communicated with global health authorities in pre-submission meetings, written information requests, mid-, and late-cycle meetings, and inspections.
Data Governance: Strategically planned and executed the development of a metadata repository that led to operational efficiencies in the software development lifecycle.
Biomedical Software Engineering: Listened to customers' voices and created a suite of software to enable independent, cross-functional data review to reduce submission cycle times.
Team Leadership: Built a group of 45 from scratch. Evaluated both business and resource needs. Developed budget and job descriptions. Recruited, trained, and developed staff. Selected vendors to augment staff as needed. Promoted recognition of individual and team contributions. Saved $250K+/- by not employing recruiters.
Risk Management: Saved BLA submission. Disputed contract research organization’s (CRO) inability to comply with FDA request, which could open the company to risks. Uncovered significant issues while auditing a Montreal-based firm. Oversaw data management and statistical components as requested by leadership.
Regulations: Worked with regulatory affairs and submission team to ensure successful electronic and physical submissions. Provided responses during FDA inspection. Soliris was approved by agencies in the US, Europe, Japan, Canada, China and other countries.

Selected Prior Career Experiences

Associate Manager, Clinical Programming, Parexel International, Inc., Lowell, MA
Senior Statistical Programmer, Quanticate, Boston, MA
Senior Statistical Programmer, Averion International, Inc., Rye, NY

Selected Career Highlights

Industry Leadership & Research: Published in the Journal of Cancer Clinical Trials for developing the first risk score to evaluate lung cancer risk in individuals with HIV. Co-authored several research articles in Journal of Clinical Oncology, Journal of General Internal Medicine, and American Journal of Obstetrics and Gynecology.
Strategic Planning & Operational Leadership: Provided strategic, operational, and technical leadership for multiple new drug applications and biological license applications, including Gomekli (mirdametinib), Ogsiveo (nirogacestat), Soliris (eculizumab), Ngenla (somatrogon), Zirabev (bevacizumab), Ruxience (rituximab), Abrilada (adalimumab), Strensiq (asfotase alfa), and Ultomiris (ravalizumab).
Strategic Partnerships & Deal Structuring: Led biometrics and cross-functional teams through the company’s first Real-Time Oncology Review (RTOR), securing FDA approval for a new drug application with critical designations. Negotiated contracts and overseeing budget management for insourced and outsourced operations.
Regulatory Knowledge: Leveraged expertise in Health Authority requirements (GCP, ICH, 21 CFR Part 11, EMA/CHMP regulations, and CDISC standards).
Business Scaling & Process Optimization: Developed expert teams in data sciences, establishing processes and technologies for biostatistics, statistical programming, clinical data management, analytics, and visualizations. Saved Biological License Application (BLA) submission by uncovering errors, taking the lead to correct mistakes, ensuring successful submission, and providing input to the FDA.
C-Suite Collaboration: Strategically collaborated with a cross-functional team of highly experienced pharmaceutical executives to provide drug development leadership and consult with health authorities worldwide in designing, developing, and deploying full-scale, cloud-based solutions to enable collaborative review by regulators. Communicated with and influenced senior management and global health authorities.
Risk Mitigation & Cost Savings: Avoided $90M loss by securing FDA acceptance for review despite new requirements. Led a submission redo 75% faster than standard timelines, ensuring compliance and successful regulatory submission.
Data Management & Emerging Technology Expertise: Led significant multi-company statistical and data management initiatives with experience engaging with health authorities and adopting new emerging technologies, including machine learning and artificial intelligence and analytics platforms, creating greater efficiencies.
Team Leadership: Hired, developed, and managed teams globally. Led insourcing initiatives, moving from 30% to 70% insourced clinical trial support. Developed roadmap and built 45-person group.

Professional Experience

Global Health Authorities

Project Management

Budget Management

Process Engineering

Due Diligence

Mergers and Acquisitions

Negotiations

Emerging Technologies

Strategic Planning

Research and Development

Scenario Planning

Quality Assurance and Control

Academic Teaching Experience

UNC at Chapel Hill, Gillings School of Public Health, Adjunct in Biostatistics, 2022–Present
Rutgers University, School of Public Health, Adjunct in Biostatistics, 2021–Present
Boston University, School of Dental Medicine, Adjunct in Biostatistics, 2006

Clinical Research

Enterprise Analytics

Predictive Analytics

Statistical Analysis

Computational Algorithms

Clinical Programming

Data Management

Data Governance

Complex Databases

Global Resource Management

Cross-Functional Team Management

Regulatory Compliance

Technology Snapshot

Core Competencies

Professional Affiliations

City of Norwalk, Board of Health, Board Member, 2014–2022
Pharmaceutical Users Software Exchange (PhUSE), Groton, CT, 2017–Present
India Association for Statistics in Clinical Trials (IASCT), Groton, CT, 2017–Present