Associate Director Clinical Pharmacology and Pharmacokinetics

Responsibilities

The Associate Director Clinical Pharmacology and Pharmacokinetics will play a crucial role in our drug discovery and development efforts, providing integrated pharmacokinetics/pharmacodynamics (PK/PD), toxicokinetics (TK), ADME and clinical pharmacology assessment of Viking’s novel therapies. This role involves managing activities and timelines, analyzing and interpreting pharmacokinetic data from preclinical studies, clinical trials and assisting with preparation and review of scientific and regulatory documents.

Essential Duties and Responsibilities

• The main Clinical Pharmacology and Pharmacokinetics responsibilities of this role include but are not limited to the following:
• Contribute to all phases of preclinical projects (non-GLP and GLP), from in vitro ADME, in vivo PK, PK/PD, formulations and IND enabling toxicology and TK analysis, along with planning and execution of pivotal in vivo PD and disease animal models
• Serve as the clinical pharmacology lead across multiple programs, owning the execution of clinical pharmacology plans from IND through early clinical development, including food effect, drug-drug interaction, organ impairment, and QT assessments.
• Design and oversee PK, PK/PD, and exposure-response analyses to support dose selection, study design, and benefit-risk assessments
• Perform non-compartmental and compartmental PK/PD analysis, modeling and simulation for preclinical, formulations and clinical studies, in collaboration with CROs, consultants, preclinical and development teams
• Oversee bioanalysis and PK deliverables, related to protocols, study synopses, preclinical and clinical study reports, briefing books, INDs, IBs, and NDAs.
• Work closely with Biometrics and external modeling partners to support population PK and exposure-response modeling
• Stay current with regulatory guidance and scientific advances in clinical pharmacology, applying best practices to development programs
• Other duties as assigned