Head of Toxicology: As a head of toxicology, the major mission of this position is to provide scientific guidance on nonclinical safety program of pRED China drug discovery and development projects, prepare regulatory documents related to nonclinical safety, and represent pRED China to interact with regulatory authorities worldwide. In addition, as a scientific leader, this position will serve as internal expert to help the project team to design and implement investigative or mechanistic safety studies to guide research and development of drug candidates. See the details below.

a.      Be a member of management team of NCS and will be actively involved in setting up strategy and direction for the department;

b.      Service as a regulatory toxicology expert to design science driven, regulation compliant NCS development plan for pRED China projects;

c.      Represent NCS in multifunctional project team to design and ensure successful execution of nonclinical safety assessment within project timeline;

d.      Contribute to deliver drug development milestones of pRED China project;

e.      Prepare and critically review regulatory documents, such as IB, IND/CTA, NDA/MAA, etc.;

f.      Represent NCS of pRED China in discussions with regulatory authorities or Roche internal meetings to solve issues and gain alliance;

g.      Be responsible for addressing questions raised by regulatory authorities for clinical trials and product registration worldwide;

h.      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;

i.      Train and develop junior scientists in NCS

1.      Education: Ph.D. or equivalent in toxicology, pharmacology, pathology, veterinary medicine, or immunology;

2.      Years of experience: at least 8 years of toxicology project support experience, ideally within pharma or biotech; training and experience in toxicologic pathology is highly desired;

3.      Scientific Experience:

*       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;

4.      Knowledge:

*       Broad background knowledge of toxicology and safety assessment;

*       Extensive knowledge of nonclinical safety related 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;

5.      Abilities:

*       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 pRED China at international meetings or Roche internal global meeting;

6.      Leadership competency:

*       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

7.      Skills:

*       Good project management skills

*       Excellent English communication skills

Contact: Catherine Qin - catherine.qin.cq1@roche.com

Roche R&D Center (China) Ltd

pRED China