Toxicology Expert

Toxicology Expert

YOUR TASKS AND RESPONSIBILITIES:

• Assess preclinical toxicology data to ensure the safety of volunteers and patients participating in clinical trials in Japan
• Ensure the adequacy, scientific quality, and regulatory compliance of the toxicology data package required to advance products through their development stages in Japan
• Identify critical toxicological findings and propose appropriate mitigation strategies or risk-reduction measures
• Prepare high-quality toxicology documentation needed for initiating clinical trials, conducting PMDA consultations, and submitting NDAs
• Respond to internal and external toxicology-related inquiries, including questions from regulatory authorities, in close collaboration with global teams
• Evaluate potential drug candidates from a toxicology and regulatory perspective as part of due diligence activities
• Actively contribute to global Preclinical Development (PCD) initiatives and cross-functional projects as a member of the global PCD organization
• Mentor and develop junior staff, helping them build strong toxicology expertise

WHO YOU ARE:

• University degree or above
• A minimum of 3-year experience in regulatory toxicology (e.g. dossier preparation, human safety assessment or related) OR in experimental toxicology as a laboratory staff or a study monitor
• Understanding of related regulations/guidelines and GLP
• Experience involved in drug development in pharmaceutical industry (more than 5 years)
• Experience involved in the regulatory submission as a representative of preclinical (more than 2 products is preferred)
• Other general skills and competencies include logical thinking skill, problem solving skill
• Skills for writing of medical scientific documents in both Japanese and English
• Good communication skill in English especially for reading and writing   ※TOEIC 650 or above as a guide
• Leadership skill, and coaching & training skill

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