Associate Director, Pharmacology & Toxicology

GenEditBio Limited; Hong Kong; On-site; HKD 1,800,000 - 2,400,000; Full time

Job summary

GenEditBio Limited in Hong Kong is seeking a Senior Non-Clinical Scientist to lead strategy and execution for in vivo gene editing programs. You will oversee CRO programs end-to-end, review protocols, track timelines and budgets, and drive high-quality non-clinical studies in alignment with global regulatory requirements.

The role requires 8–12 years in non-clinical R&D with a track record in IND submissions and collaboration across discovery, CMC, clinical, and regulatory teams.

Qualifications

• Master’s/PhD in Pharmacology, Toxicology, Molecular Biology, Veterinary Medicine, or related field.
• 8–12 years non-clinical R&D experience in innovative drug development with at least 3 years of team management.
• IND submission experience with priority for in vivo gene editing, mRNA‑LNP, AAV or CGT products.
• Deep familiarity with NMPA, FDA (CBER/OTP), EMA, and ICH non-clinical guidance for gene therapy/biotech.
• Solid in vivo pharmacology; animal models, surgical procedures, data analysis.
• Proficient in English and Chinese as working languages; capable of English regulatory submissions and meetings.

Responsibilities

• Lead non-clinical development strategy and execution for in vivo gene editing pipelines.
• Oversee CRO-managed programs end-to-end: protocol review, timelines, budgets, reports.
• Apply innovative evaluation frameworks (humanized mouse, NHP) to assess distribution, persistence, and editing efficiency.
• Lead off-target risk assessment and integrate bioinformatics with NGS validation data.
• Draft and integrate non-clinical modules for IND/BLA submissions; liaise with regulators.
• Guide pharmacology & toxicology team; translate non-clinical data into clinical risk mitigation and dosing guidance.

Skills

Team leadership

Regulatory alignment

Cross-functional collaboration

Scientific writing

Regulatory submissions

In vivo pharmacology

NGS data analysis

Education

Master’s/PhD in Pharmacology/Toxicology

Tools

NGS data analysis

Bioinformatics

Job description

Primary Responsibilities

• Non-clinical development strategy and execution
• For in vivo gene editing pipelines (e.g., liver targeting, ophthalmology, central nervous system, etc.), independently develop and lead high-quality non-clinical pharmacology, pharmacokinetics, and toxicology study strategies in full compliance with NMPA, FDA, and EMA regulatory requirements.
• Oversee CRO-managed outsourced programs (both GLP and non-GLP studies) end-to-end, including protocol review, timeline tracking, budget control, and final report delivery.
• Apply innovative evaluation frameworks (e.g., humanized mouse models, non-human primate models) to address scientific challenges in assessing in vivo distribution, persistence, and editing efficiency of gene editing therapeutics.
• Tackling gene-editing-specific safety challenges Lead seamless off-target risk assessment strategies, integrating bioinformatics predictions with high-depth NGS in vivo validation data to build a robust evidence chain for safety.
• Design and interpret key toxicology studies targeting risks associated with gene editing systems (e.g., CRISPR/Cas immunogenicity such as anti-Cas antibodies and T-cell responses, chromosomal translocations, and insertion mutation risks).
• Establish and refine in vivo gene editing therapeutic efficacy-related biomarker and gene editing efficiency assessment systems (e.g., Indel rates / base conversion rates).
• Regulatory submission and regulatory affairs As a core writer, lead the drafting, review, and integration of non-clinical modules (e.g., M4, S6, etc.) for regulatory submissions such as IND/BLA, ensuring scientific integrity and logical completeness of the overall dossier. Serve as the company’s representative to communicate efficiently with regulatory authorities (e.g., NMPA, FDA) and provide precise responses to review center questions regarding non-clinical data and experimental design.
• Team leadership and cross-functional collaboration Guide and develop the pharmacology & toxicology team’s day-to-day operations and professional growth, fostering an environment of positive innovation and meticulous rigor. Act as a key interface for non-clinical studies, working closely with Drug Discovery (Target Validation), CMC (formulation and process), Clinical, and Regulatory Affairs teams—translating non-clinical data into clear clinical risk mitigation and dosing guidance.

Requirements

• Master’s/PhD degree in Pharmacology, Toxicology, Molecular Biology, Veterinary Medicine, or a related field.
• 8–12 years of non-clinical R&D experience in innovative drug development, including at least 3 years of team management experience.
• Must have successful IND submission experience in full. Candidates with relevant clinical-pre development experience in in vivo gene editing, mRNA‑LNP, AAV, or other CGT (Cell & Gene Therapy) products will be given absolute priority.
• Deep familiarity with regulations and a thorough understanding of NMPA, FDA (especially CBER/OTP), EMA, and ICH non-clinical evaluation guidance principles for gene therapy/biotechnology products (e.g., ICH S12, S18, etc.).
• Solid in vivo pharmacology foundation; expert in small-/large-animal surgical procedures, disease model development, and sample analysis.
• Deep understanding of gene editing tools at the mechanistic level (e.g., DSB repair mechanisms, single-base conversion/transversion); able to independently review NGS sequencing data and bioinformatics analysis reports.
• Chinese and English as a working language; able to write English regulatory submission materials fluently and chair international meetings.