Investigative Tox Senior Manager~Director Department：Early Development Location：Zhangjiang, Shanghai The Company Harbour BioMed is a Global Biotherapeutics Company primarily focused on inventing, developing, manufacturing and commercializing novel therapeutics for the treatment of serious medical conditions in oncology, and immunology. HBM has labs and business operations in Cambridge in the US, Rotterdam in Netherlands and Shanghai and Suzhou, China. We aim to help people with complex and debilitating conditions by identifying unmet medical and patient needs and driving strong science supported by our two patented transgenic mouse platforms for generating fully human monoclonal antibodies. Our approach is shaped by our experienced team’s capability in delivering highly specialized treatments and forging close relationships with physicians and patients to understand the NextGen treatments that will provide hope to patients and their families around the world. Responsibilities: 1. Assist the ED head to establish an integrated system to enhance our internal oversight on “Toxicology & Safety Platform”, from the early discovery phase through the entire clinical development to commercial launch 2. Learn and provide an assessment on the target associated toxicity, and the mechanisms of toxicity observed nonclinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients 3. Collaborate on the design of non-GLP investigative and pharmacology studies to support development compounds 4. Act as a safety team representative responsible for the drug safety strategy of novel target/therapeutic candidates. One’s ability to understand the toxicity of the platform versus target-related toxicities is key 5. Working with the teams, develop study protocols and reports, and write various regulatory documents (e.g., pre-IND packages, IND/CTAs, BLAs/NDAs, Investigator Brochures), as well as presenting to and interacting with regulatory agencies (e.g., FDA or EMA) 6. Assist in developing and delivering an overarching strategy for the delivery of toxicology data, which may include internal resources and/or external partners and consultants 7. Build collaborative networks internal and external to the company to ensure rapid communication and cross-functional evaluation and investigation of emerging safety issues 8. Develop strong knowledge of the basic biology of the intended target of drug candidates Requirements: 2 1. PhD degree with training in toxicology, immunology or related disciplines 2. 4+ years of postgraduate experience in toxicology or immunology in a contract research organization and/or pharmaceutical/biotech setting; designing studies, interpreting data, generating reports and regulatory documents 3. Experience in nonclinical safety assessment from discovery through development, especially with mAbs 4. Proven success in scientific investigation of fundamental toxicology issues, either through scientific publications or drug development experience 5. Good verbal and written communication, excellent interpersonal and information management skills 6. Collaborate effectively with the study team, cross-functional team members, and external partners. If you are interested in applying for this position, please contact us at lisa.xu@harbourbiomed.com