Nonclinical Development & Translational Medicine Advisor

About the role

We are looking for an external, part‑time advisor to guide nonclinical development, toxicology and translational medicine for our neurodevelopmental disorder programs using AAV‑delivered RNA‑editing therapeutics. The role is primarily remote with an on‑site option in Beijing and involves close collaboration with internal teams and CRO partners.

Key responsibilities

• Provide Sponsor‑side oversight of CRO‑developed study protocols for CNS‑administered AAV programs, including toxicology, biodistribution and related nonclinical studies.
• Identify scientific, safety and regulatory risks, recommend mitigation strategies, and help determine which studies are necessary and the level of evidence required.
• Guide safety‑risk assessment, biodistribution and toxicology strategies for novel AAV serotypes/capsids and evaluate animal model designs.
• Address mechanism‑specific risks of RNA editing and advise on appropriate nonclinical evaluation.
• Offer translational medicine expertise on PK/PD, safety margins, first‑in‑human dose selection and dose‑escalation strategies.
• Support regulatory interactions and submission strategy for FDA INTERACT, Pre‑IND, IND and NMPA/CDE engagements in China.

Required profile

• 10+ years of experience in nonclinical development, toxicology or translational medicine for innovative therapeutics.
• Hands‑on experience with nonclinical development of AAV gene therapies, preferably with novel capsids/serotypes.
• Strong understanding of CNS‑administered product development and neurodevelopmental disorder programs.
• Experience supporting FDA IND, Pre‑IND and INTERACT submissions and familiarity with NMPA/CDE requirements.
• Demonstrated ability to independently assess scientific merit, necessity and regulatory adequacy of nonclinical studies.

Required skills

• AAV vector development and capsid assessment
• CNS toxicology and biodistribution study design
• Nonclinical study design and CRO oversight
• Regulatory submission preparation (FDA IND, Pre‑IND, INTERACT)
• NMPA/CDE regulatory processes
• Translational medicine – PK/PD, safety margins, FIH dose selection
• RNA editing safety risk assessment