A leading pharmaceutical company is advertising a vacancy for a Clinical Pharmacologist who will join their team in Shanghai. This is an exciting opportunity to work with a dynamic and innovative organisation and provide real expertise to the role.
- Serving as bioanalytical expert in the clinical pharmacology group on PK and PD samples.
- Overseeing PK, PK/PD, and DMPK biopharmaceutical analyses performed with a variety of tools and approaches.
- Serving as DMPK expert in the assigned development project team, leading the study design, and coordinating pharmacokinetic/DMPK related elements for projects.
- Identifying potential risks and providing mitigation strategies from DMPK perspective.
- Collaborating with the investigator sites, investigators, CRO, or other Partners and ensuring high quality standards of their deliverables.
- Reviewing and ensuring PK or PD analysis plan and reporting in phase I, II, and III under minimal guidance from the line manager.
- Communicating data in regulatory documents and meetings.
- Writing DMPK sections of regulatory filings at various stages of drug development and responding to regulatory queries.
- Being proactive, working with teams to resolve clinical pharmacology related issues, and ensuring timely and efficient project progression.
Skills and Requirements:
- PhD in Drug Metabolism, Disposition and Pharmacokinetics, or a related discipline.
- Minimum of 3 years of industry experience with investigation of drug metabolism, transporters, and biotransformations of therapeutics.
- Good oral and written capability of English/Chinese.
- Knowledge of bioanalytical expertise, pharmacokinetics, metabolism, drug interactions, and regulatory requirements.
- Some experience and expertise in modelling, such as PK/PD and PBPK is a desirable plus.
- Proficiency in English.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kirsty Zhuang at firstname.lastname@example.org or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.