Simon Metenou

About Simon Metenou

Accomplished immunologist and translational medicine leader with a proven track record in drug development, biomarker discovery, and regulatory strategy across oncology, infectious diseases, and autoimmune disorders. Skilled in preclinical and clinical development, translational and precision medicine strategies, and advancing programs from discovery through late-stage trials.I bring deep expertise in pharmacodynamic (PD) and pharmacokinetic (PK) studies, biomarker validation, and genomic/proteomic profiling, enabling precision medicine and companion diagnostics in both solid and hematologic malignancies. I have extensive knowledge of regulatory frameworks (IND, CTA, CTP, IB, CSR, DSURs, FDA/EMA interactions, Project Optimus), as well as compliance with IVDR, CLIA/CLSI, and ISO 13485.Recognized for building and leading high-performing cross-functional teams, fostering cultures of transparency, respect, and scientific excellence. Adept at managing multimillion-dollar budgets, driving cost efficiencies while accelerating clinical milestones. Selected AccomplishmentsPipeline Expansion & Innovation – Led development of novel immunotherapies, including PRGN-2012, the first FDA-approved immunotherapy for recurrent respiratory papillomatosis (RRP), and multifunctional fusion proteins. Secured business development opportunities with WuXi Biologics, BMS, Merck, GSK, Assembly Bio, and Gilead Sciences.Regulatory Strategy & Clinical Advancement – Contributed to INDs, CTAs, CTPs, Q-submissions, IBs, CSRs, DSURs, and FDA/EMA meetings (EOP1/2/3), facilitating successful approvals and advancing global programs.Precision & Translational Medicine Leadership – Designed and executed PD/PK strategies integrating genomic, molecular, and proteomic profiling to drive companion diagnostics for CAR-T therapies and T-cell engagers in oncology.Strategic Partnerships & Business Development – Established high-value collaborations with biotech and pharma partners, securing multimillion-dollar investments and advancing innovative programs.Operational Excellence – Reduced translational research budgets from $3.9M to $2.1M while meeting 100% of clinical milestones for SL-172154 (Sirp-α/CD40).Scientific Leadership & Innovation – Co-inventor on multiple patents, contributor to high-impact publications, and presenter at ASCO, ASH, and EHA, advancing the field of immuno-oncology and therapeutic vaccines.

Experience

1. Senior Director, Translational Sciences

   Cellectis

   Nov 2025 — Present · NY, US

   Provide strategic leadership for the definition and evolution of the Translational and Precision Science/Medicine strategies to ensure a sustainable, competitive, and value-creating early development pipeline across allogeneic cell and gene therapies. Build and scale translational capabilities by defining key roles, governance, processes, and cross-functional interfaces to enable tight integration with Discovery, Gene Editing, CMC, Clinical Development, Regulatory, and Data Sciences. Lead the clinical translation of novel gene-edited cell therapies, including allogeneic CAR-T programs, through innovative experimental medicine, biomarker, and translational pharmacology strategies that support drug development life cycle. Design and execute mechanism-of-action, proof-of-biology, and early proof-of-concept frameworks to de-risk programs and accelerate development timelines. Accountable for the development, qualification, and global execution of all cellular, molecular, and immune-monitoring biomarker assays supporting early-phase clinical trials, including flow cytometry, functional assays, genomic and transcriptomic profiling, and circulating biomarkers. Ensure high-quality data generation, regulatory compliance, and robust data transfer to support multiple concurrent trials. Serve as a key interface between Discovery Research, Gene Editing, CMC, and Clinical Development, contributing to early development plans, study design, protocol authoring and amendments, and endpoint and assessment strategies. Oversee Clinical Pharmacology and Pharmacokinetics approaches adapted to cell therapy modalities, including cellular kinetics, persistence, expansion, and immunogenicity. Direct and coordinate translational activities to optimize the value of Cellectis’ cell and gene-editing platforms, manage CROs and specialty laboratories globally, and act as a core contributor to portfolio governance and early go/no-go decisions through rigorous translational risk–benefit assessments.

Education

• University of Yaounde I

  Bachelor of Science (BSc), Zoology/Animal Biology

  1991 — 1993

• University of Buea

  Parasitology -Immunology

• Georgetown University

  Doctor of Philosophy (PhD), Immunology

  2001 — 2006

• University of Yaounde I

  D.E.A (Diplome d'Etude Approfondie) Advanced Study Degree , Infection and Immunity

• University of Yaounde I

  Master of Science (MSc), Parasitology

  1994 — 1996

Skills

• Talent Management
• Molecular Biology
• Fluorescence Microscopy
• Neuroscience
• Cell Biology
• Lifesciences
• Coaching
• In Vitro
• Cell Culture
• Executive Leadership
• Immunology
• Life Sciences
• Mentoring
• Immunohistochemistry
• Microscopy
• Clinical Research
• Public Health
• Genetics
• Pcr
• Flow Cytometry
• Animal Models
• Biochemistry
• Research