Head of Toxicology

Principal Responsibilities/Duties

• Be a member of management team of NCS and will be actively involved in setting up strategy and direction for the department;
• Service as a regulatory toxicology expert to design science driven, regulation compliant NCS development plan for R&D China projects;
• Represent NCS in multifunctional project team to design and ensure successful execution of nonclinical safety assessment within project timeline;
• Contribute to deliver drug development milestones of R&D China project;
• Prepare and critically review regulatory documents, such as IB, IND/CTA, NDA/MAA, etc.;
• Represent NCS of R&D China in discussions with regulatory authorities or the company’s internal meetings to solve issues and gain alliance;
• Be responsible for addressing questions raised by regulatory authorities for clinical trials and product registration worldwide;
• Service as a champion in NCS to lead investigative toxicology studies as necessary to study the mechanism of toxicities identified from the routine toxicity studies;
• Train and develop junior scientists in NCS;

Qualification/Requirement

• Ph.D. or equivalent intoxicology, pharmacology, pathology, veterinary medicine, or immunology;
• at least 8 years of toxicology project support experience, ideally within pharma or biotech; training and experience in toxicologic pathology is highly desired;
• Experience of representing NCS organization in cross functional drug R&D teams
• Hands-on experience of designing complex toxicology program to support drug development projects;
• Proven experience of preparation of regulatory documents, such as IB, IND/CTA, NDA/MAA, etc.;
• Track record of successful interaction with regulatory authorities;
• Experience with global pharmaceutical development is desired;
• Broad background knowledge of toxicology and safety assessment;
• Extensive knowledge of nonclinical safetyrelated industrial practice and regulations/guidelines from ICH, OECD, FDA, EMA, and SFDA, etc.;
• Must be familiar with GLP regulations;
• Knowledge of pediatric drug development and juvenile animal study is a plus;
• Ability to build trustful and effective working relationship with external and internal collaborators, such as CROs, universities, research institutes, and regulatory agencies;
• Be able to represent NCS of R&D China at international meetings or the company’s internal global meeting;
• Proven ability to effectively share ideas and influence audience within a broad spectrum of scientific disciplines
• Self-motivated with a strong ability to motivate others to deliver milestone within project timeline
• Good project management skills
• Excellent English communication skills