A leading global pharmaceutical company that specialise in the development of biological therapies is advertising a vacancy for a PK position. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas. Based in Shanghai, this is an exciting opportunity to work with an internationally renowned establishment.
- Design and influence clinical pharmacology/DMPK strategy for assigned programs in liaison with appropriate line functions and the Management.
- Coordinate DMPK, PK/PD, biopharmaceutical and M&S activities for preclinical and clinical projects.
- Identify potential project hurdles, suggest solutions, and establish contingency plans.
- Contribute expert input into key preclinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, modelling reports, investigator brochures, CTA's/IND's and NDA's within agreed timelines, and meet all regulatory requirements under minimal guidance from manager.
- Analyze, interpret, and apply DMPK, PK/PD and M&S data to guide clinical development strategy, study design, and responses to health authorities.
- Present summary information (written and oral) both internally and externally to advisory panels, investigator meetings, and health authorities as part of the regulatory approval process.
- Ensure constructive collaboration within drug development teams (EPTs, GPTs, etc.) and with other internal partners (e.g. Toxicology, Formulations, Drug Regulatory Affairs, Clinical Development).
- Monitor timelines, objectives, and, as appropriate, program budgets.
- Assure rapid and effective communication of high-quality data and results to project teams.
- Follow internal processes, adhere to Novartis and project-specific standards, and adhere to health authority requirements (e/g., SOPs, Master Analysis Plan, GCP, and regulatory guidelines).
- Maintain and enhance technical and drug development expertise, may act as technical subject matter expert in key clinical pharmacology/DMPK related area.
Conduct due diligence and prepare appropriate documentation, when needed.Skills and Requirements:
- Bachelor's degree, preferably in a scientific discipline.
- 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 email@example.com or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical 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.