北京招聘

Key Areas of Responsibilities:

The successful candidate will be responsible and accountable for safety strategy and for design and execution of all safety studies from discovery to early/late development projects. S/He will manage all interactions with vendors and ensure delivery of study results and reports consistent with project timeline. Additionally, s/he will be accountable for the delivery of proper documents for regulatory filings.

Job Requirements:

?PhD or Master in Pharmacology, Biology, Toxicology, or related scientific discipline.

?PhD 5+ years, or Master 8+ years of experience in a pharmaceutical or biotechnology management of nonclinical safety activities for discovery and development programs

?Develops and oversees execution of phase appropriate nonclinical safety strategy & integrated project plans including milestones, timelines, resources and budgets.

?Serve as a subject matter expert for GLP, non-GLP, and safety pharmacology studies. Ensure appropriate expertise is available to represent the company as the nonclinical safety expert before regulatory authorities

?Extensive experience in working with and managing international CROs for protocol design and study execution

?Accountable for delivery of audited and timely delivery of high-quality safety reports to enable clinical plans and regulatory filing submissions in multiple markets.

?Identify, lead, manage, and build a long-term relationship with CROs for delivery of nonclinical safety studies for pharmaceutical and nutraceutical candidates.

?Accountable for all safety associated regulatory and quality documents associated with INDs and other regulatory submissions and documentation.

?Ensures effective communication and collaboration of all involved functions and third parties.

?Responsible to forecast and manage nonclinical safety program investment plans

?Proactively manages risk and drives project related decisions to ensure teams are successful in achieving their goals and team milestones.

Preferred traits:

?Broad understanding of all aspects of nonclinical safety and experienced with regulatory filings; thorough knowledge of relevant NMPA, FDA and EMA regulations

?Self-motivated, delivery-oriented, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.

?Proven experience in managing teams, budgets and resources

?Project management skills

?Ability to deal with ambiguity

维泰瑞隆（北京）生物科技有限公司是一家全球性的专注于研发First-in-class化学药物的生物制药公司。该公司由北京生命科学研究所的所长，美国科学院院士，中国科学院外籍院士王晓东博士和北京生命科学研究所资深研究员张志远博士共同创建。公司坐落在昌平区中关村生命科学园。
本公司针对王晓东博士在细胞凋亡、细胞程序性坏死等多种细胞死亡领域的原创性发现研发小分子抑制剂，致力于多种重大疾病的治疗。这些抑制剂针对的疾病包括神经退行性疾病如阿尔兹海默症、多发性硬化症、帕金森病等；缺血性疾病如脑卒中、肾缺血、心肌缺血；以及炎症性疾病如肠炎、银屑病、脓毒症等。
本公司研发能力涵盖小分子筛选，化学合成，分子、细胞生物学研究，动物药效评价，药代药动分析及临床前预毒理分析等药物研发的所有环节。
本公司的研发团队由王晓东博士和张志远博士直接领导，团队主要成员均具备十年以上科学研究经验，前期科研成果均发表在国际学术刊物如，Cell，Molecular Cell, eLife，PNAS 等。
本公司的管理团队均具备数十年国际制药企业的管理经验，曾成功推动多个药物进入临床实验和上市使用。
公司福利待遇：对于优秀博士公司有机会解决北京***问题；公司设有博士后工作站。