プロフィール詳細

プロジェクトを作成

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Dr. Armen A.に依頼

United States

Senior Medical & Clinical Development Expert | Oncology | Immuno-Oncology | Medical Writing | Global Trial Leadership

プロフィール概要

Medical Strategy & Advisory: Shaping clinical development plans for breakthrough oncology assets (e.g., Durvalumab, Toripalimab, Trilaciclib), leading to FDA approvals. Medical Writing: Authoring protocols, CSRs, IBs, regulatory submissions, and scientific publications (peer-reviewed journals). Global Trial Leadership: End-to-end management of 12+ Phase I–IV multicenter trials in oncology, psychiatry, and other therapeutic areas. Cross-Functional Leadership: Direct collaboration with Biostats, Data Management, Regulatory, PV, and commercial teams. Client & KOL Engagement: Representing sponsors in bid defenses, investigator meetings, and strategic negotiations. Core Competencies Clinical Study Protocol & CSR Development (ICH-GCP, ICH E3/E6) Medical Monitoring & Safety Oversight (CTCAE, MedDRA) Immuno-Oncology (PD-1/PD-L1, TIGIT, STING pathways) Regulatory Submissions (FDA, EMA) Project & Budget Management ($1M–$10M+) Scientific Publications & Medical Communications AI-Enhanced Clinical Operations

専門分野

• ☆ Pharmacy
• ☆ Clinical Pharmacy
• ☆ Drug Development
• ☆ Small Molecule Drug Development
• ☆ Biologic & Biosimilar Development
• ☆ Drug-Drug Interactions
• ☆ Investigational New Drug (IND) Application Consulting
• ☆ Bioavailability
• ☆ Clinical Trials
• ☆ Clinical Trial Design
• ☆ Patient Recruitment
• ☆ Clinical Trials Data Analysis
• ☆ Pharmacovigilance/Drug Safety Monitoring
• ☆ Primary Care/Family Medicine
• ☆ Oncology
• ☆ Chemotherapy
• ☆ Surgical Oncology
• ☆ Precision Medicine
• ☆ General Surgery
• ☆ E-Health & Telemedicine
• ☆ Immunotherapy
• ☆ Gene Therapy
• ☆ Medical Terminology
• ☆ Medical Sciences
• ☆ Pharmaceutical Management
• ☆ Business Operations
• ☆ Business Strategy

サービス

• Writing
• Research
• Consulting
• Product Development

Writing Clinical Trial Documentation, Medical Writing

Research Market Research, User Research, Feasibility Study, Scientific and Technical Research, Systematic Literature Review

Consulting Business Strategy Consulting, Healthcare Consulting, Operations Consulting, Scientific and Technical Consulting

Product Development Concept Development

職務経験

Medical Director

IQVIA (United States)

8月 2020 - 現在

Medical Director

IQVIA

8月 2020 - 3月 2025

学歴

Medical Degree (MD)

NMRC of Oncology named after N.N.Petrov of MoH of Russia

1月 2017 - 1月 2018

認定資格

• Medical Oncology

  Pavlov First Saint Petersburg State Medical University

  7月 2025 - 現在

出版物

JOURNAL ARTICLE

Armen Andreasyan, María Aimé Giorlando, C. Escorial, C. Gabay, E. Ortega, E. Mari, Laura Schnetter, L. Mendoza Navas(2023). Comparative Analysis of Gender-Based Differences in NSCLC between Europe and Asia . OpenAlex. OpenAlex

María Aimé Giorlando,, C. Escorial,, C. Gabay,, E. Ortega,, E. Mari,, Armen Andreasyan,, Laura Schnetter,, L. Mendoza Navas(2023). Comparative Analysis of Gender-Based Differences in NSCLC between Europe and Asia . OpenAlex

Armen Andreasyan & Luis Mendoza. (2022). Emergent New Anti PD-1/PD-L1 Small Molecules for Cancer Treatment. International Research Journal of Oncology, 5(1), 18–24. Retrieved from https://www.journalirjo.com/index.php/IRJO/article/view/91 .