Director/SD of DMPK based in US/Beijing

吴红岩医药荐客 2022-01-04

职位1：Director, Head of DMPK-Beijing

Key Responsibilities

• Maintain and develop DMPK platform technology and capability

• Lead DMPK group and work with CROs to design, analyse, report pharmacokinetic and pharmacodynamics studies and results to support internal drug discovery projects.

• Be responsible to assess ADME and physicochemical properties of NCEs, plasma protein binding, permeability, solubility, stability, IVIVE and DDI from early leads, preclinic candidate to clinic drug candidate, at all stages of drug discovery process.

• Join project teams at the early stage to ensure effective integration of pharmacokinetics and accelerate the progress and facilitate the translational efforts at the later stage. Make dose assessment in animal models and humans.

• Be familiar with and suggest for formulation methods and TK study design. • Communicate and represent as a PK expert internally and externally

Minimum Requirements

• Ph.D. in Pharmaceutical Sciences, Pharmacology, or related field with extensiveexperience on DMPK/ADMET and bioanalysis, with a specific focus on pharmacokinetics.

• Familiar with exploratory tox, animal studies, and animal dose formulation, as well as in vitro-in vivo extrapolation and the capability to use PK software for data analysis and modelling is a plus.

• A minimum of 10 years pharmaceutical industry experience in the conduct of pharmacokinetic and pharmacodynamics support.

• Desirable to have experience as a team lead representing DMPK department on interdisciplinary project teams.

• Fluent in English for both writing and presentation

职位2：Director/SD of DMPK-US(WFH)/Guangzhou

Key responsibilities include:

Oversees and is responsible for all DMPK activities
Develops close, collaborative working relationships across functions especially with toxicology, clinical, and pre-clinical pharmacology groups
Responsible for ensuring collaboration of DMPK team representatives with clinical colleagues to ensure integration of DMPK insights into clinical programs and alignment of nonclinical DMPK and clinical activities related to drug metabolism and pharmacokinetics
Ensures adequate DMPK representation on project teams in research and development
Collaborates with research to develop critical pathways to select development candidates
Designs and oversees conduct of DMPK studies that support clinical trials and product registration
Provides oversight for preparations of DMPK portions of regulatory submissions (IND) and clinical documents (IB)
Interacts with regulatory agencies on drug metabolism and pharmacokinetic issues related to development projects
Critically evaluates project data while rigorously driving data-driven Go/No-go decisions, including the identification of resource constraints and bottlenecks
Promotes an overall group culture of agility, pro-action, collaboration, and innovation

Requirements:

PhD required. Experience in the pharmaceutical industry (5+ years)
Ability to work with interdisciplinary teams
Communicates in a clear and concise manner to both internal and external
Excellent organizational and time management skills
Experience preparing regulatory submissions and supportive documents
Demonstration of highly successful project execution across disease areas using in-house and/or CRO resources leading to preclinical candidates for further clinical development
Impeccable attention to detail, and excellent ability to perform hands on experiments, research/design/organize projects and maintain detailed documentation
Strong understanding of the drug discovery process and demonstrated leadership on cross-functional teams