Magali Taiel
Chief Medical Officer @ GenSight Biologics
About
Accomplished biotechnology and pharmaceutical executive with 25+ years of global leadership across Clinical Development, Translational Medicine, Regulatory Strategy and Medical Affairs. I specialize in advancing rare disease and ophthalmology programs, including AAV/gene therapy, optogenetics, and antisense oligonucleotides. Recognized for building high-performing cross-functional teams, driving innovative clinical strategies, and accelerating global development timelines. Career Highlights Chief Medical Officer leading end-to-end clinical programs for advanced ophthalmic gene therapies, Phase 1–3, with oversight of Clinical Development, Regulatory Affairs and Medical Affairs. Led translational and clinical programs for inherited retinal diseases such as LHON, LCA10, and Usher syndrome, publishing in Nature Medicine and presenting at international conferences. Successfully supported ~$200M in fundraising and investor communications, enhancing corporate development and pipeline visibility. Extensive regulatory experience with FDA, EMA, MHRA, and other international authorities, advancing global registration and early access pathways. Expertise Global Clinical Development Leadership (Phase 1–3b/4) Gene Therapy, Optogenetics & Rare Disease Therapeutics Translational Medicine & First-in-Human Programs Regulatory Strategy & Health Authority Engagement (FDA, EMA, MHRA) Cross-Functional Team Leadership & Executive Decision-Making Protocol Design, SAP/CSR Oversight, Advisory Board & KOL Engagement Market Access & Patient Advocacy Leadership I am passionate about translating innovative science into therapies that improve patient outcomes globally. Connect to discuss leadership in clinical development, rare disease strategies, or advanced therapy execution.
France
Paris
Pharmaceuticals
Clinical Practice Management, Advisory Board, KOL & Investigator Engagement, Patient Advocacy & Early/Expanded Access Programs, First-in-Human & Registration-Enabling Programs, Protocol Design & Medical Oversight, Executive Cross-Functional Leadership, Translational Medicine & Early Development, FDA, EMA & MHRA Regulatory Strategy, Rare Disease & Ophthalmology Leadership, Gene Therapy & Advanced Modalities (AAV, Optogenetics, RNA Therapeutics), Global Clinical Development (Phase 1–3), Research and Development (R&D), Pharmaceutical Research, Project Management, Clinical Data, Regulatory Submissions, Strategic Leadership, Pre-clinical Development, Management, Clinical Operations
Experience

Chief Medical Officer
Great Paris Metropolitan Region
Lead global medical, clinical, and regulatory strategy for advanced ophthalmology gene therapies, building high-performing teams and aligning initiatives with corporate growth. Key Achievements: Directed global Phase 1–3 programs for LHON (GS010/Lumevoq) and optogenetic therapy (GS030), enabling EMA registration submission. Served as primary medical lead for regulatory engagement with FDA, EMA, MHRA, and international agencies. Implemented early and expanded access programs, increasing patient availability and regulatory readiness. Led the global Medical Department, overseeing Clinical Development, Non-Clinical Development, Clinical Operations, Medical Affairs, and Regulatory Affairs while managing a multidisciplinary team of 10+ professionals. Published clinical findings in Nature Medicine and other high impact journals, and supported ~$200M fundraising initiatives.

VP CLINICAL DEVELOPMENT
Great Paris Metropolitan Region
Oversaw clinical development and scientific communication across ophthalmology portfolio, ensuring regulatory readiness and strategic program execution. Key Achievements: Managed four global Phase 3 trials with long-term follow-up for LHON, producing data to support registration filing. Advanced GS030 optogenetic therapy through Phase 1/2 study with innovative endpoints. Prepared multiple regulatory interactions with EMA and FDA, aligning global development strategy. Mentored and led clinical teams (7 professionals), optimizing execution and collaboration. Led scientific publications and enhanced external visibility for advanced therapies.

VP CLINICAL DEVELOPMENT - OPHTHALMOLOGY
Leiden, The Netherlands
Directed early clinical programs in RNA-targeting/antisense oligonucleotide therapies for inherited retinal diseases. Key Achievements: Led Phase 1/2 and Phase 2/3 planning for LCA10, Usher2A, and RP programs, applying Bayesian methods to optimize trial design. Oversaw translational medicine strategy and clinical program leadership for multiple rare ophthalmology diseases. Generated data supporting publications in Nature Medicine. Guided cross-functional teams to accelerate development timelines and regulatory readiness. Strengthened scientific validation and external visibility for RNA-based therapies.

REGIONAL MEDICAL THERAPEUTIC AREA LEAD - CARDIOVASCULAR and RHEUMATOLOGY - FRANCE & BENELUX
Greater Paris Metropolitan Region
Led regional medical strategy for cardiovascular and rheumatology programs, supervising 5 medical professionals and aligning regional operations with global development. Key Achievements: Directed clinical strategy for five therapeutic molecules across Phase 2, 3, and 3b/4 trials. Built partnerships with regulators, KOLs, investigators, and academic institutions to strengthen evidence generation. Managed reimbursement and market access strategies in collaboration with Daiichi Sankyo. Chaired international advisory boards and expert panels. Enhanced regional clinical adoption and regulatory alignment through multi-stakeholder engagement.

MEDICAL DEPARTMENT LEAD - CV, RHEUMATOLOGY, INTENSIVE CARE, UROLOGY - FRANCE
Greater Paris Metropolitan Region
• Leadership across cardiovascular, rheumatology, intensive care and urology portfolio; supervision of 6 team members. • Led international Phase 3 and Phase 3b/4 clinical studies and health outcomes studies. • Led medical strategy across 7 molecules. • Medical lead for three launches: Efient in acute coronary syndrome, Cialis in benign prostatic hyperplasia, and Adcirca in pulmonary arterial hypertension. • Served as Alliance Medical Manager for Daiichi Sankyo and GSK. • Chaired advisory boards.

EUROPE MEDICAL THERAPEUTIC AREA LEAD - CV
Greater Paris Metropolitan Region
Directed European cardiovascular programs, managing 11 professionals and aligning regional strategy with global objectives. Key Achievements: Managed Phase 3, 3b/4, and health outcomes programs across 10+ countries. Developed compassionate use programs and authored reimbursement dossiers in multiple markets. Chaired international steering committees and advisory boards. Authored clinical protocols and CSRs, ensuring regulatory compliance. Strengthened global development programs for Efient and Reopro.

MEDICAL THERAPEUTIC AREA LEAD - INTENSIVE CARE - FRANCE & BELGIUM
Greater Paris Metropolitan Region
Directed medical strategy and product launch for Xigris in critical care. Key Achievements: Managed Phase 3, 3b/4, and health outcomes studies. Developed CSR and publication strategy aligned with global standards. Authored reimbursement dossiers for Belgium and chaired advisory boards. Supported adoption of innovative critical care therapies across France and Belgium. Delivered cross-functional medical leadership for launch success.

MEDICAL ADVISOR - OPHTHALMOLOGY - FRANCE
Greater Paris Metropolitan Region
Supported and managed ophthalmology portfolio including glaucoma and AMD therapies. Key Achievements: Coordinated European regulatory support and KOL engagement for product approvals. Authored market access files and drove adoption for Xalacom. Oversaw Phase 3b/4 and health outcomes studies, ensuring robust clinical evidence. Strengthened scientific positioning of ophthalmology therapies across Europe. Led external engagement and advisory board activities for program validation.

R & D INTERNATIONAL PROJECT MANAGER: DIABETOLOGY and RHEUMATOLOGY
Greater Paris Metropolitan Region
Coordinated multinational Phase 2 and Phase 3 studies, ensuring operational consistency and regulatory compliance. Key Achievements: Centralized project management across global sites for protocol adherence. Streamlined cross-functional collaboration with international affiliates. Facilitated alignment between headquarters and regional teams for timely decision-making. Ensured high-quality data collection and study implementation. Supported global standardization and best practices for clinical studies.
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