杭州招聘

Geneception Bio, Inc. is a privately held, early stage gene/cell therapy company founded in 2019. The company is based in Shanghai, China. We are leveraging the most recent scientific discovery and developing treatment for the most devastating diseases, dramatically improving the life-quality of patients. We are seeking a highly motivated Toxicologist for a director position. This role requires strong scientific and technical expertise in Toxicology. The candidate will need to remain current on key topics on the safety of gene therapy, providing risk assessment in time for all programs. The candidate will also lead the design and implementation of nonclinical safety strategies across research and development programs, and work in close collaboration with colleagues in research, translational sciences, bioanalysis, project management, , and regulatory affairs to execute the company's overall development strategy. The candidate must have excellent organizational and interpersonal skills with the ability to communicate effectively with different functional groups. This is a perfect position for a scientist with a strong toxicology background, who has a can-do attitude, strong work ethic and ambitious goal for career development.

Responsibilities:
? Oversee risk assessments to identify potential adverse effects and outcomes for all programs, propose and test scientific hypotheses by a variety of analytical techniques
? Provide advises to key decision makers on scientific and regulatory strategies and direction, facilitate program progress by delivering sound regulatory packages
? Serve as a toxicology representative in our internal program teams and in-licensing reviews
? Build and maintain external relationships with other gene therapy KOLs to stay abreast of most recent changes in the scientific and regulatory landscape in the field
? Collaborate closely with all program leads and focus on DSRD to enable program strategies, development plans, regulatory packages/correspondence and filings
? Represent toxicology as a member of programs, nonclinical, and clinical trial working teams, contributing to candidate selection strategy, and designing, executing, and finalizing nonclinical study reports for submission
? Partner with the discovery group and work with nonclinical DMPK colleagues to optimize nonclinical models and inform first in patient clinical dosing strategies
? Identifying and managing consultants and CROs to support toxicology studies

Requirements:
? Ph.D. or equivalent training in toxicology or related disciplines with at least 5 years of bio/pharmaceutical industry drug development experience in nonclinical safety/toxicology
? Strong understanding of toxicology principles, the drug development process and regulatory guidance to support nonclinical safety strategies for FIH studies
? Familiarity with current practices in the following areas: discovery and regulatory toxicology, DMPK and translational research
? Extensive experience in designing and executing nonclinical safety studies to support lead candidate selection
? track record in leading nonclinical safety efforts for the successful discovery and development of therapeutics
? Experience with preparation of the clinical pharmacology portions of regulatory documents such as the pre-IND, IND, IB, FIH starting dose justifications
? Ability to exercise good judgement, problem-solving skills, strong analytical and organization expertise

Note to External Recruiters:
All candidate activity and open positions are managed strictly through our Human Resources Department. Our Human Resources Department kindly requests that:
1, Recruiters not contact employees/hiring managers directly in an attempt to solicit business and present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation.
2,Without prior authorization with an official contract, Recruiters not to contact potential candidates using Geneception’s company name, logo, position information, our leadership team members’ names, etc; any un-authorized efforts of approaching candidates with Geneception’s company information will not create an implied obligation, and Geneception will trace the recruiters’ activities of spreading any authorized or misleading information among the candidates, appropriate legal actions will be taken by Geneception when necessary;

赋源生物是一家创新驱动的生物制药公司，致力于基因和细胞治疗的药物开发，以及在全球范围内的临床研发及商业化。

赋源生物总部位于上海，自2019年成立以来，公司已经打造行业一流的研发和管理团队，并在上海张江落成6000平米的自主研发中心，成为国内基因与细胞研发领域的研发中心。公司将以此为起点，积极推进自主研发与对外合作研发项目，尽快满足病患临床需求。

公司已经完成1.5亿美金A轮融资，由高瓴资本、红杉资本和ARCH Venture Partners领投，创始投资机构斯道资本、F-Prime Capital和礼来亚洲基金跟投。