Serving as a team representative, manage individual project and provide scientific and technical expertise of DMPK/Clinical Pharmacology to cross-functional teams; identify and communicate potential project hurdles and suggest solutions.
Representing DMPK/Clinical Pharmacology function, collaborate with members in other functional areas, such as pharmacology, toxicology, CMC, biostatisticians, regulatory affairs and clinical operations; assist in design and development of nonclinical/clinical study protocols to ensure that protocols capture critical PK, PK/PD endpoints; aid in selection of optimal dose regimen, human starting dose for nonclinical toxicology studies and clinical trials.
Interacting with CROs, oversee execution of nonclinical DMPK/TK studies and clinical pharmacology trials; provide guidance to the study conduct based on study protocol.
Manage PK datasets for importing to WinNonlin; perform NCA using WinNonlin or related software; interpret study results and write stand-alone PK or PK/PD reports and/or PK/PD sections for CSRs.
Contribute to DMPK/Clinical Pharmacology related sections to regulatory documents, such as IB, annual report, INDs, NDAs, BLAs.
10% travel to project related activities.
Qualifications and Skills:
A Master, Ph.D. or equivalent degree in Pharmacokinetics or Pharmaceutical Sciences
2 years of industry experience is desired; must have knowledge in DMPK or Clinical Pharmacology field
Proficiency in Microsoft; expertise in using WinNonlin or related software for NCA
Excellent communication and writing skills are required
About TG Therapeutics
TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases.