Head of Preclinical Development

Head of Preclinical Development

YOUR TASKS AND RESPONSIBILITIES:

• Oversee and support the following;
  • Prepare the preclinical part of J-NDA and PAA dossiers (efficacy pharmacology, safety pharmacology, DMPK and toxicology) for successful registration of Bayer products in Japan in close collaboration with global functions
  • Prepare appropriate responses to preclinical inquiries from Japanese health authorities in close collaboration with global functions
  • Support the conduct of clinical trials in Japan according to agreed timelines by providing preclinical data and related information
  • Provide preclinical input to relevant local functions for efficient product development in Japan
  • Work with BUs to facilitate and resolve issues for newly launched and labelled products in Japan
  • Provide preclinical expertise for due diligence activities to identify new candidates
  • Collect and provide valuable preclinical information and relevant regulatory requirements
• As a member of the Global Preclinical Development leadership team, contribute to the successful development of Bayer's early projects and development pipelines from a toxicology and DMPK expert perspective
• Demonstrates, credibly embodies and role models VACC leadership being a(n):
  • Visionary that guides teams in defining the outcomes to deliver on the mission
  • Catalyst that removes road blocks to facilitate connections and collaboration
  • Architect that shapes a value creating system to unleash the passion and energy of our people
  • Coach that helps teams learn and build the capabilities needed to create value for the customer and stakeholders
• Manage budgets, headcount, resource allocation, HR issues and support appropriate training opportunities for Preclinical Development Japan members

WHO YOU ARE:

• University degree or above
• At least 10 years professional knowledge and expertise in the preclinical area (Toxicology, DMPK and Safety Pharmacology) and sufficient knowledge and experience in the drug development business
• Sufficient experience in management and global communication/collaboration experience
• Languages:  Japanese: Native speaker or equivalent   English: Excellent listening, speaking, reading and writing skills
• General impression of skills and qualifications: Adequate basic skills and qualifications are required. Jobholder needs to encourage and guide the group members to an objective direction with excellent management skills, e.g., leadership, endurance and consideration/care, as the members of this organization are true experts in their respective fields

WHAT BAYER CAN OFFER YOU:

• We offer a competitive a salary package consisting of an annual basic salary and Short-Term Incentive (STI) bonus and top performance award and so on, tailored to your role at Bayer
• We provide various special paid day-offs on top of given annual paid vacation days. Also, we promote work-life balance by offering employees flexible working hours and home-office arrangements depending on your job nature in alignment with your manager
• We support your professional growth by providing learning and development opportunities through training programs, regular feedback and project participations
• At Bayer, our employees are welcomed, supported, and encouraged to reach their full potential. We also embrace and respect diversity by providing an inclusive and fair work environment for all employees
• We provide various attractive corporate benefit programs for all of our valuable employees such as DC pension plan, health and medical support by Bayer Health Insurance Association, Benefit Club membership, and life insurance