Worked closely with Translational Sciences, Clinical Development, Clinical Biometrics, Clinical Operations staff and external vendors as a subject matter expert in pharmaceutical bioanalysis, in vitro and in vivo drug metabolism, preclinical and clinical pharmacokinetics and the design and conduct of clinical drug interaction and human [14C] metabolism studies.
Contributed to program DMPK strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.
Also, worked with preclinical and clinical CROs and company scientists to conduct and monitor clinical and preclinical studies, maintain study records and ensure study completion along program timelines.
Provided scientific leadership, direction and management of all preclinical and clinical DMPK, and the development of short and long-term objectives, particularly in support of the development of emixustat, an oral visual cycle modulator for a blinding eye disease and prepared PK & PK/PD components of internal & regulatory documents (e.g. IND, NDA, IB).
Represented Clinical Pharmacology across departments including Research, Clinical Operations, Clinical Development, Biostatistics and Regulatory Affairs groups.