美国新泽西药企需要毒理和PKPD(PS to AD level)
Company Introduction
An emerging company focusing on the development of the best-in-class immunotherapy technology for cancer cure. Teamed up with outstanding immunologists and molecular biologists, Legend has generated a strong pipeline of Chimeric Antigen Receptor (CAR) product candidates to treat a wide variety of liquid and solid tumors.
Principal Scientist/Associate Director of Toxicology
Role Overview:
The position functions as the leader in safety assessment with demonstrated experience in biopharmaceutical drug development (prior experience with gene and cell therapy products preferred) with the following responsibilities
Major Responsibilities:
• Works directly with discovery and development project teams to design and interpret nonclinical safety studies for our CAR T cell programs, including decision analysis, risk minimization strategies, regulatory acceptability and issue resolution.
• Clearly identifies and communicates potential project hurdles, suggests solutions and establishes priorities and contingency plans in collaboration with project team participants, the line functions and the wider Nonclinical Safety Assessment Community of our collaborators as appropriate.
• With the head of preclinical development, negotiates with Health Authorities (HA) worldwide regarding safety issues, scientific interpretation and acceptability of the sponsor’s data.
• Negotiates and ensures appropriate nonclinical safety support to all assigned projects is optimal in terms of quality, timing and cost.
• Establishes and maintains effective safety assessment outsourcing strategy and vendor relationships.
• Leads the preparation and presentation of all internal and external documentation relating to nonclinical safety aspects (e.g. Investigator’s Brochure, IND/IMPD, CTD, Health Authority briefing books).
• Manages communications and relationship-building with regulatory authorities worldwide in collaboration with Drug Regulatory Affairs (DRA) and management team.
• Evaluates in/out-licensing opportunities and carries out Due Diligence activities as required.
• Manages and mentors the Nonclinical Safety Assessment organization.
Key Relationships:
Report to the head of Preclinical Development Department
Qualifications
Education:
PhD in pharmacology, toxicology or a related bioscience field; MD, DVM or PharmD with relevant work experience
Experience:
Experience with diverse biopharmaceutical portfolio with 2- 5 years working experience in industry or with regulatory agency; prior experience with gene/cell therapy products preferred.
Key Capabilities, Knowledge, and Skills:
• Advanced knowledge of scientific disciplines involved in drug safety assessment and the relevant laboratory tools and procedures related to safety assessment and risk management, including PK-PD aspects of study design and data interpretation.
• Detailed knowledge of drug development processes and worldwide regulatory guidelines.
• Ability to collaborate and manage conflicting situations in a matrix environment.
• Proven negotiation skills.
• Excellent organization and project management skills.
• Self-motivated and able to operate independently
Associate Director/Principal Scientist of Quantitative Pharmacology
Position Overview
Role Overview:
The position functions as the Subject Matter Expert of Quantitative Pharmacology to support oncology drug development
Major Responsibilities:
• Designs, analyzes and interprets quantitative pharmacology and pharmacokinetic data
• Performs modeling and simulation analysis of preclinical/clinical as well as translational PK/PD data to predict human efficacious dose/dose regimen
• Works with nonclinical group to determine biomarkers and pharmacology plans
• Participates in the designs and execution of integrated Clinical Pharmacology plans to support clinical development of CAR-T therapies at Legend Biotech
• Participates in the drafting and finalization of clinical study protocols and study analysis plans (SAP)
• Drafts and reviews clinical pharmacology study reports and clinical study reports
• Serves as a clinical pharmacology consultant to research teams, clinical development, commercial teams, and address regulatory authorities questions related PK/PD
• Understand the unique challenges in quantitative pharmacology evaluation of cell therapies. Leverages literature data or external collaboration to develop new methodologies and propose/test hypotheses
Key Relationships:
Report to the head of Preclinical Development Department
Qualifications
Education:
PhD in Pharmacokinetics, Pharmaceutical Sciences or Pharmacology or equivalent with relevant working experiences
Experience:
Knowledge and understanding of drug development process with a minimum of 2 years working experience in biotech or pharmaceutical industry
Key Capabilities, Knowledge, and Skills:
• Knowledge and experiences of pharmacokinetics, PK/PD and quantitative pharmacology analysis
• Hands on experiences using one or more commercially available PK analysis and modeling platforms e.g. Phoenix/WinNonlin, NONMEM, MATLAB, SimBiology, etc.
• Understanding of overall drug development process
• Ability to collaborate and maintain effective working relationship both internally and externally
• Good communication and technical writing skill
• Capable of being innovative and dynamic in approach to work
往期文章：
100个ANDA，24家药企，2018年中国制药国际化道路再创佳绩
北京外企招聘蛋白化学,分子生物,NGS,Exosomes,Screening等
我的目标
1）海外生物医药人才的寻访
2）海外生物医药项目融资和引进
欢迎有兴趣的朋友和我合作，电话/微信：13564288425，hongyan258@126.com
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