Vincent Dinescu

About Vincent Dinescu

With over 15 years of leadership in regulatory strategy and medical writing, I specialize in transforming complex scientific data into clear, compelling, and approvable regulatory narratives for oncology and immunology programs.My expertise spans the entire development lifecycle, guiding assets from preclinical planning through successful global marketing applications (IND, NDA, BLA, MAA). I excel at building cohesive submission stories by partnering seamlessly with cross-functional experts in Clinical, Biostatistics, Nonclinical, and CMC.I have a deep, hands-on command of the Common Technical Document (CTD) and eCTD formats, with extensive authoring and strategic oversight of all modules. This includes authoring high-impact summary documents (2.5 Clinical Overview, 2.7 Clinical Summaries), managing critical safety reports (DSUR, PBRER), developing robust Investigator\'s Brochures (IBs), and creating pivotal documents like the ISS and ISE.A core focus of my work is ensuring CMC and clinical alignment. I provide strategic writing for key CMC sections (QOS, 3.2.S, 3.2.P), including control strategy narratives, comparability reports, and justification of specifications.My experience extends to leading preparations for and participating in key health authority interactions (FDA, EMA), from pre-IND and End-of-Phase 2 meetings to pre-BLA/NDA consultations and navigating responses to regulatory inquiries (RFIs, Day 120 Questions).Areas of Expertise:Regulatory Strategy & Submissions: IND, NDA, BLA, MAA, sNDA/sBLA, Rolling Submissions, Post-Approval Variations & SupplementsMedical & Regulatory Writing: CSRs, IBs, Protocols, ISS, ISE, DSURs, PBRERs/PSURs, Risk Management Plans (RMPs), Orphan Drug (ODD) & Pediatric Plan (PIP/PSP) submissionsCTD Module Expertise: Modules 1-5, with a focus on Module 2 (2.3 QOS, 2.4, 2.5, 2.6, 2.7), Module 3 (CMC), and Clinical/Nonclinical Study Reports (Modules 4 & 5)Health Authority Interactions: Briefing Packages (pre-IND, EOP2, Type B/C), RFI Responses, Pre-Submission MeetingsExpedited Programs: Breakthrough Therapy (BTD), Fast Track, PRIME, RPDDTherapeutic Modalities: Small Molecules, Peptides, Biologics, Antibody-Drug Conjugates (ADCs)I am passionate about bridging clinical strategy with submission excellence to bring transformative therapies to patients. Currently supporting innovative FcRn-targeted programs.

Experience

1. Director Medical Writing

   Immunovant

   Jul 2024 — Present · New York, NY, US

   Lead author and cross-functional strategist for regulatory and clinical documentation across Immunovant’s FcRn inhibitor portfolio, spanning multiple autoimmune indications.Lead clinical development strategy and medical writing operations for FcRn portfolio across multiple autoimmune indicationsCollaborate on clinical study design and protocol development, providing clinical development expertise for IND submissionsSuccessfully contributed to clinical development strategy for 2 IND submissions across 2 therapeutic programsManage a high-performing team of internal medical writers, including Associate Directors, and oversee external writing consultants across multiple global programs.Deliver strategic oversight and hands-on authorship of INDs, protocols, investigator brochures (IBs), briefing documents, safety narratives, and FDA/EMA response packages.Played a lead role in coordinating and submitting over 250 regulatory responses in under 12 months, helping to advance multiple programs through early- and late-phase development.Partner closely with Regulatory Affairs, Clinical Development, Biostats, and CMC to ensure messaging alignment and submission readiness under aggressive timelines.Developed and implemented SOPs, style guides, and QC frameworks to streamline cross-program document workflows and elevate content consistency across global filings.Contribute to executive leadership communications and agency interactions, including briefing content for Type B meetings and regulatory milestone events.

Education

• Columbia University

  Bachelor of Arts (BA), Biochemistry and pre-Med

• Columbia Business School

  Innovation and Entrepreneurship , Innovation & Entrepreneurship

Skills

• Physics
• Energy Conservation
• Biofuels
• Cell Biology
• Solar Energy
• Microbiology
• Biology
• Immunology
• Developmental Biology
• Systems Biology
• Biophotonics
• Environmental Biotechnology
• Financial Modeling
• Stem Cell Research
• Biomedical Engineering
• Human Physiology
• Biochemistry
• Renewable Energy
• Biotechnology
• Stem Cells
• Business Analysis
• Food Technology
• Energy Efficiency
• Virology
• Biological Control
• Bacterial Physiology
• Food Science
• Biological Nutrient Removal
• Chemistry
• Fertilizers
• Organic Synthesis
• New Business Development
• Energy Management
• Molecular Biology
• Inorganic Chemistry
• Energy Industry
• Organic Chemistry
• Energy
• Animal Feed
• Hydrogen Production