We are looking for a qualified and experienced clinical pharmacologist to join our team and contribute to the development and evaluation of new and existing medications. As a clinical pharmacologist, you will be responsible for designing, conducting and analyzing clinical pharmacology studies, as well as providing expert advice on pharmacokinetic and pharmacodynamic aspects of drug development and regulatory submissions.
We are also looking for someone who has done renal impairment, hepatic impairment, drug-drug interaction, transporter, QT prolongation, biomarker. The Clinical Pharmacologist needs to have non-generics experience.
What are the key responsibility of the role?
- Plan and direct clinical pharmacology studies in collaboration with internal and external partners
- Apply pharmacokinetic and pharmacodynamic modeling and simulation techniques to optimize study design, data analysis and interpretation
- Use biomarkers and intermediate clinical endpoints to support dose selection, efficacy and safety assessment of drug candidates
- Prepare and write clinical study protocols, reports and regulatory documents in compliance with relevant guidelines and standards
- Communicate and present clinical pharmacology findings and recommendations to internal and external stakeholders
- Work across a variety of functions involved in drug development, such as preclinical, clinical, regulatory, biostatistics and medical affairs
- Work across international time zones to coordinate with global teams and vendors
- A Ph.D., Pharm.D. or M.D. degree in clinical pharmacology or a related field
- At least 12-14 years of experience in clinical pharmacology research in the pharmaceutical industry or academia
- Knowledge of biomarkers and intermediate clinical endpoints and their use in drug development
- Proficiency in pharmacokinetic and pharmacodynamic modeling and simulation software, such as Phoenix WinNonlin, NONMEM or R
- Experience in preparing and writing clinical study protocols, reports and regulatory documents, such as INDs, NDAs or BLAs
- Excellent communication, presentation and interpersonal skills
- Ability to work independently and collaboratively in a multidisciplinary team
- Ability to work under pressure and meet deadlines