Johnson & Johnson Careers

Head Nonclinical Safety - China

Shanghai, China
Toxicology Research


Job Description

Requisition ID: 1905723020W

  • Responsible for overall nonclinical safety (NCS) operations in China as part of the global nonclinical safety organization.  Will have “dotted line” reporting to the Head of China R&D and Scientific Affairs and will serve on the Leadership Team in both organizations. 
  • As the site head of NCS China, responsible for strengthening the local organization in China and integrating the activities into global organizational structures/processes as appropriate; as a global leadership team member, supporting NCS’s goals and objectives; ensuring the adherence of global standards (including GLP, OECD, FDA, ICH, and AAALAC) and local compliance requirement (NMPA and other APAC region) so that products can be successfully and efficiently registered globally or locally. Budgeting and talent development are also part of the major responsibilities.
  • As a leadership team member of China R&D and Scientific Affairs, responsible for integrating the NCS China operations into the China R&D organization and supporting its goals and objectives, and meeting the China quality and compliance standards. Overseeing and responsible for the preclinical aspect of all China drug development program needs in coordination with global NCS team.
  • As the only preclinical safety group in China for Johnson & Johnson, support cross-sector preclinical business needs as required. 
  • Engages in building strong relationship with NMPA and local key opinion leaders.  Represents Janssen Pharmaceuticals and be active at the Preclinical Subgroup team of RDPAC, lead or contribute to identified task forces. 
  • Partner with NCS animal welfare experts and governance to assure appropriate selection, oversight and compliance regarding animal protocols conducted within CRO’s in China. Serve as the JCRD’s IACUC committee chair.
  • Build or maintain strong partnerships with local CROs that we work to deliver optimal work products.

Qualifications
  • DVM/MD, and/or Ph.D. in pharmaceutical sciences and has experience in both small and large molecule development. Has board certification in DABT or ACVP.
  • 15+ years of experience in preclinical development, with emphasis on satisfying regional expectations for nonclinical safety packages and regulatory filing of IND, CTA, and NDA/BLA in China and other global regions. 
  • Has experience in partnering with cross-industry consortia (e.g. EMEA, PhRMA, RDPAC) to influence regulatory environment as well as navigate through challenging issues.   
  • Experience in working with NMPA/CDE for registration consultation and/or supporting other initiatives is preferred.   
  • 10 + years of people management experience.
  • Has enterprise mindset, knowledge of external business environment, especially in China/Asia region.
  • Agile in a matrix environment.
  • Possess entrepreneur spirit and able to manage ambiguity.
  • Strong leadership, interpersonal and negotiation skills. 
  • Fluent in English and Mandarin, familiar with Chinese culture.


Primary Location
China-Shanghai-Shanghai-
Organization
J&J (China) Investments Ltd (7046)
Job Function
Toxicology Research
Requisition ID
1905723020W