Armaghan D.

Clinical Scientist @GENFIT

Lead the transition from pre-clinical research to early clinical development for 2 projects, advancing Proof-of-Mechanism and PoC studies, integrating cross-functional expertise (Pharmacology, CMC, Regulatory, Non-Clinical) to strengthen human target validation and identify early efficacy biomarkers or safety signals.• Involved in the conception and design and development of the synopsis, protocol, and briefing book (BB) for a Phase 1b/2a proof-of-concept (POC) clinical trial, supporting a pre-IND FDA submission.• Leadership in 2 RWE projects, in close collaboration with the Data Strategy and Bioinformatics teams, including launching 1 global survey and 1 EMR data extraction project.• Oversight of 2 protocol and clinical trial document amendments for regulatory submissions, ensuring timely resolution of cross-functional comments.• Authorship of clinical trial protocols and synopses for 1 Phase 1 study including hepatic and renal impaired patients, following the FDA and EMA guidances.• Development of protocols and synopses for 1 Phase 1 study involving healthy volunteers.• Medical leadership in creating 2 Target Product Profiles (TPP) to support strategic early-phase FDA submissions, and to inform pharmacological developments.• Active collaboration with cross-functional teams in 3 different Core Team meetings for different compounds early-stage developments, facilitating alignment across clinical, regulatory, and operational functions.• Continuous monitoring of scientific literature, performing advanced searches, and managing the product library and bibliography to provide accurate, up-to-date information for cross-functional teams.• Preparation of responses for unsolicited medical inquiries, anticipation of emerging trends, and analysis of inquiry data to inform strategic medical communication.• Close partnership with IT to test and integrate a new database, improving efficiency and data accuracy for medical information management.