In collaboration with clinical research scientists, the senior clinical research scientist ensures that bioequivalence studies, project evaluations and due diligence are as per the requirements from different health authorities and company's objectives. Provide creative suggestions of a study design for a complex drug product, e.g. complicated pharmacokinetics or formulations. The senior clinical research scientist is the primary contact with regulatory agencies for bioequivalence and clinical study queries. The senior clinical research scientist is responsible for outsourcing the bioequivalence studies.
This role will also be responsible for performing pharmacokinetic / pharmacodynamic analyses of data generated through clinical and preclinical studies.
The main responsibilities of this position are as follows: