Head of Translational Development (Shanghai/Nantong)
Posted by: Ractigen Therapeutics
Posted date: May-24-2019
Location: Nantong or Shanghai
This position will be responsible for translational development of Ractigen’s drug programs throughout the non-clinical process into clinical development. This position will be expected to lead a team of translational scientists to design, validate, and execute translational plans, as well as work closely with Drug Discovery and Early Drug Development teams to provide input on assay development and experimental design.
1. Report to:
This position reports directly to CEO.
Plan, lead, and execute non-clinical IND projects.
Develop and manage a functional budget for IND projects.
Establish milestones, timelines, workflows and make sure projects’ milestones and major objectives are met.
Oversee translational development by helping research teams develop robust translational data packages to support early clinical proof-of-concept, as well as research needs of post-POC clinical programs.
Work closely with Preclinical Development and analytical teams to provide input on lead compound development and design of mechanism of action studies.
Guide in-house pharmtox studies.
Guide non-clinical and clinical pharmacology to determine FIH dose and schedule, development/execution of plans to analyze PK, drug metabolism, pharmacodynamics, etc.
CMO/CRO selection, audit, and management including acquiring quotes/cost estimates for GLP and non-GLP studies, resolving issues that may rise during contracted work, coordination between multiple contractors, etc.
Responsible for drafting clinical study-related and regulatory documents such as IND applications, Clinical Study Reports, IBs, etc.
Communicate with regulatory agencies in regards to pharmtox or other aspects of the Pre-IND/IND process.
Participate in the development of clinical trial protocols, facilitate smooth transition to clinical teams and execute clinical programs.
Responsible for establishing and improving R&D quality management system, including but not limited to, various rules, policies and SOPs.