Summary
Overview
Work History
Education
Skills
Career Experience
Languages
Timeline
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Diane DeFilippo

Needham,MA

Summary

Operations Executive Performance-driven leader offering extensive experience in project and operations management combined with strong business acumen in life sciences and pharmaceuticals. Adept at delivering proactive leadership to achieve project deliverables within stringent time and budgetary constraints. Instrumental in assessing regulatory capabilities, processes, systems to enhance organizational value, operational efficiency, and compliance with strategic priorities. Proven success in collaborating with key stakeholders and cross-functional departments in driving strategic business planning, change management, and well-informed decisions throughout the organization. Skilled in transforming complicated information into robust solutions to meet business needs. Demonstrated capacity to manage preclinical to commercial portfolio, covering pipeline governance, metrics, KPIs, analytics, and information management. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

Overview

11
11
years of professional experience

Work History

Head – Regulatory Project Management

Moderna, inc
04.2023 - Current
  • Supported launch readiness & approvals globally for COVID-19 New Variant
  • Built out scenario planning for different strains and global dossier, timeline assessment if monovalent vs bivalent
  • Regulatory Project Management team head (team of 12) optimizing processes and tools integrations, designed one-stop shop pages for programs for submission planning /templates, operational excellence of processes not in place plus robust training materials
  • Active training for AI optimization for populating health authority responses, translation of global dossiers, meeting minutes/action item tracking, and developing content plans
  • Facilitated global planning activities with country heads, cross-functional leads on filing plan
  • Led strategic and operational process workstreams with core working group based on identified process gap/pain point
  • Designed portfolio tools to capture metrics of baseline planning vs actuals, heat map of overallocated activities, and snapshot of all Regulatory specific activities with key fields.

Director – Regulatory Project Management

Moderna, inc
04.2023 - 08.2023
  • Supported launch readiness & approvals globally for COVID-19 New Variant
  • Built out scenario planning for different strains and global dossier, timeline assessment if monovalent vs bivalent
  • Regulatory Project Management team head (team of 12) optimizing processes and tools integrations, designed one-stop shop pages for programs for submission planning /templates, operational excellence of processes not in place plus robust training materials
  • Active training for AI optimization for populating health authority responses, translation of global dossiers, meeting minutes/action item tracking, and developing content plans
  • Facilitated global planning activities with country heads, cross-functional leads on filing plan
  • Led strategic and operational process workstreams with core working group based on identified process gap/pain point
  • Designed portfolio tools to capture metrics of baseline planning vs actuals, heat map of overallocated activities, and snapshot of all Regulatory specific activities with key fields.

Associate Director – Regulatory Science

2seventy Bio (company split from bluebird bio)
01.2019 - 04.2023
  • Submitted and acquired clearance of IND for bbT369 (investigational novel CD79a/CD20)
  • Gathered and reviewed Health Authority feedback from pre-IND engagement as well as develop roadmap for initiating IND development
  • Oversaw line management functions and update key stakeholders with risk mitigation and status of submissions impacting regulatory success
  • Managed and communicated overall submissions and regulatory risks across programs to senior leadership
  • Devise and deploy efficient processes, SOPs, systems, and tools for company split
  • Analyzed regulatory capabilities, processes, systems to pinpoint gaps within regulatory science to drive value, operational efficiency, and compliance with strategic priorities
  • Led forward planning / scenario planning teams to ensure clear alignment between cross-functional teams
  • Expanded the scope of Regulatory Operations by growing and diversifying the department to new methods of tracking Health Authority feedback via analytical tools, automate processes that were manual through the use of data and technology.

Senior Manager - Regulatory Science

Bluebird Bio
01.2019 - 01.2020
  • Formulated three-way regulatory operational and communication process of bluebird bio with CMO, Thermo Fisher Scientific, Sponsor, and Bristol-Myers Squibb Company
  • Streamlined overall functions pertaining to submission of BLA, MAA, and Information Request (IR) period
  • Managed timelines, data drivers, meeting facilitation, and prompt communication with cross-functional SMEs to supervise forthcoming activities, meet deliverables, and mitigate risks
  • Coordinated with Sickle Cell Global Regulatory team in proposing submissions for next five years and structuring gating data drivers, rate limiting factors, and risks
  • Gained Biologics License Applications (BLA) and Marketing Authorization Application (MAA) approval of Abecma (idecabtagene vicleucel), the first CAR T cell therapy for multiple myeloma
  • Designed efficient resource allocation dashboard to flag resources with overlapping priorities across programs in Oncology and Severe Genetic Disorder
  • Ensured effective management of CMC risks and Lentiviral Vectors (LVV) activities for BLA and MAA while serving as Regulatory CMC Project Manager
  • Expertly established (led, planned, designed training) collaborative processes with BMS partners for joint submission collaborative model, IR collaborative model, and lifecycle management collaborative model.

Associate Director, R&D Program Management – ARISTADA

Alkermes PLC
01.2018 - 01.2019
  • Acted as Program Manager for ARISTADA (aripiprazole lauroxil) to superintend ongoing and newly designed phase 4 clinical / registry studies and key messaging with cross-functional colleagues from commercial, investor relations, medical affairs, clinical research / development, legal, and regulatory
  • Interacted with multidisciplined experts to align scientific communication activities and materials for phase 4 studies
  • Developed and implemented alternative program growth strategies
  • Supported success of Aripiprazole Lauroxil two-month dosage launch giving patients 2 months of treatment in a single data with ARISTADA INITIO and ARISTADA 1064 mg
  • Oversaw key portfolio activities and communicated health check of program through interactive dashboards.

Associate Director, Medical Affairs and Interim Chief of Staff

Alkermes PLC
01.2017 - 01.2018
  • Enabled successful execution of new key initiatives within medical affairs, covering portfolio field medical team (MSLs), congress planning, professional society engagements, IITs, and advisory boards
  • Performed baseline assessment of medical affairs systems to overcome identified gaps and capitalize on opportunities for improvement
  • Managed and supported the re-structuring of the MSL organization for Medical Affairs
  • Oversaw and delivered all activities related to the operation of the MD&MA leadership team that required sensitivity and discretion
  • Actively drove the strategic planning forward- developed executive-level / leadership communications including board of direction presentations, governance presentations, weekly status reports and tracking.

Project Manager, Medical Affairs

Alkermes PLC
01.2016 - 01.2017
  • Conducted in-depth Health Economics and Outcomes Research in trending outcomes with a focus on varied disease areas
  • Quantified key insights from thought leaders in treating patients within schizophrenia, depression, and addiction areas.

Project Manager | Project Specialist, Multiple Sclerosis Global Medical Affairs Operations

Sanofi Genzyme
01.2013 - 01.2016
  • Defined and documented program status, risk management, and success metrics
  • Managed MS Medical Materials Review Committee (MMRC) and created new process used across numerous therapeutic areas
  • Met stringent deadlines during launch of LEMTRADA (Alemtuzumab), including MMRC review of materials
  • Facilitated medical communications and Research & Development teams in producing posters and content for congresses / forums.

Education

Bachelor of Science in Marketing & Communication -

Johnson and Wales University

Associate in Science in Business Administration (Concentration: Financial Services Management) -

Johnson and Wales University

Skills

  • Strategic Agility & Planning
  • KPIs & Metrics’ Monitoring
  • Visualization Systems: Power BI, Tableau, Smartsheet
  • Global Submission Content Planning and Submission (eCTD, IND, BLA, MAA, CMC Variations)
  • System expert (Microsoft systems, Smartsheet, MS Project, OnePager, Veeva RIM)
  • Process Optimization
  • Artificial Intelligence (AI) Applications
  • Launch Excellence
  • Team Development & Leadership
  • ICH Guidelines / GCP
  • Organization and Time Management
  • Interpersonal Communication
  • Teamwork and Collaboration
  • Supervision and leadership
  • Dependable and Responsible
  • Multitasking Abilities
  • Organization
  • Project management
  • Risk assessment
  • Conflict resolution
  • Process improvement
  • Data Interpretation
  • Agile Methodology
  • Dashboard Design
  • Interactive Visualization
  • Analytical and Critical Thinking

Career Experience

  • Moderna, inc, 04/2023, Present, Head – Regulatory Project Management
  • Moderna, inc, 08/2023, Present, Head – Regulatory Project Management
  • Moderna, inc, 04/2023, 08/2023, Director – Regulatory Project Management
  • 2seventy Bio (company split from bluebird bio), 2019, 2023, Associate Director – Regulatory Science
  • Bluebird Bio, 2019, 2020, Senior Manager - Regulatory Science
  • Alkermes PLC, 2016, 2019, Associate Director, R&D Program Management – ARISTADA
  • Alkermes PLC, 2017, 2018, Associate Director, Medical Affairs and Interim Chief of Staff
  • Alkermes PLC, 2016, 2017, Project Manager, Medical Affairs
  • Sanofi Genzyme, 2013, 2016, Project Manager | Project Specialist, Multiple Sclerosis Global Medical Affairs Operations

Languages

Spanish
Native or Bilingual

Timeline

Head – Regulatory Project Management

Moderna, inc
04.2023 - Current

Director – Regulatory Project Management

Moderna, inc
04.2023 - 08.2023

Associate Director – Regulatory Science

2seventy Bio (company split from bluebird bio)
01.2019 - 04.2023

Senior Manager - Regulatory Science

Bluebird Bio
01.2019 - 01.2020

Associate Director, R&D Program Management – ARISTADA

Alkermes PLC
01.2018 - 01.2019

Associate Director, Medical Affairs and Interim Chief of Staff

Alkermes PLC
01.2017 - 01.2018

Project Manager, Medical Affairs

Alkermes PLC
01.2016 - 01.2017

Project Manager | Project Specialist, Multiple Sclerosis Global Medical Affairs Operations

Sanofi Genzyme
01.2013 - 01.2016

Bachelor of Science in Marketing & Communication -

Johnson and Wales University

Associate in Science in Business Administration (Concentration: Financial Services Management) -

Johnson and Wales University

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Diane DeFilippo