Asieris Pharmaceuticals (688176.SH), founded in March 2010, is a global innovative pharma company specializing in new drugs for the treatment of genitourinary tumors and other major diseases. We strive to improve human health and help people live a more dignified life. We aim to become a global pharma leader that integrates R&D, manufacturing and commercialization in our areas of focus, as we provide best-in-class integrated diagnosis and treatment solutions for patients in China and worldwide.
The Head of Toxicology will be part of the Preclinical Development group supporting small molecule drug development at Asieris and will provide scientific expertise and leadership to the safety assessment of all Asieris programs. The candidate is expected to work in a highly collaborative team environment, playing a pivotal role at each stage of preclinical and early clinical development.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Provide expert support, guidance and strategy on project safety assessments, with a specific focus on discovery & IND-stage small molecule projects.
• Serve as the key resource for toxicology, providing scientific knowledge and expertise to cross-functional project teams.
• Develop overall toxicology strategy and plans for lead candidates based on clinical development plan.
• Oversee preclinical toxicology studies at multiple external Contract Research Organizations (CRO).
• Design & execute investigative toxicology studies, based upon off & on-target safety profiles of the candidate drugs.
• Initiate appropriate processes for contract implementation, protocol development, and timeline optimization for toxicology studies.
• Monitor toxicology studies for appropriate conduct, accuracy and timely execution; audit raw data for accuracy, review draft reports and finalize them as submission-ready documents for regulatory authorities.
• Proactively respond to study issues and resolve problems with study director.
• Internal and external communication
• Prepare verbal and written summaries for internal discussions. Work with the Preclinical Development team to develop optimal strategies to address specific safety issues and partner with project teams.
• Review and/or author toxicology and/or safety pharmacology sections of various regulatory documents (e.g., pre-IND briefing documents, INDs, IBs etc.) and ensure their regulatory compliance.
• Represent company at meetings with regulatory agencies.
• Present summary data to project teams and Asieris senior leadership.
EDUCATION AND EXPERIENCE:
Ph.D. in Toxicology, Pathology, Physiology, Biochemistry or expertise in related biological science disciplines, with an emphasis on Oncology/Immunology is preferred. Ph.D.; Board Certification in Veterinary Anatomic Pathology (ACVP) and Board Certification in Toxicology (DABT) is highly desired.
• 10+ years’ experience in toxicology small molecule drug development in Biotech/Pharma industry.
• Experience in filing multiple INDs is a must; experience in filing NDAs will be a plus.
• An in-depth understanding of toxicology and/or toxicologic pathology, and have experience designing and critically evaluating results of exploratory and GLP-compliant toxicology studies.
• Experience in supporting project team as toxicology representative.
• Excellent oral/written communication skills in English and Chinese.
• Additional expertise in specific toxicology areas, e.g. developmental & reproductive systems toxicology, endocrine systems toxicology, Toxico-kinetics/Toxico-dynamics simulation analyses etc., is a strong plus.
COMPENSATION & BENEFITS:
As a full-time employee of the Company, you will be eligible for company benefits：
• Flexible Working hours
• Paid Vacation
• 401k Plan
• Medical Insurance
• Year-end Performance Bonus
• Long Term Incentive Plans
Interested candidates please feel free to contact:
Human Resources – Ms. Cao Email: firstname.lastname@example.org