Associate Director Clinical Pharmacology and Pharmacokinetics

Job Description

Job Description

Description:

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

Requirements:

Education and Experience

• Ph.D., Pharm.D., or equivalent in clinical pharmacology, pharmaceutical sciences or a related field with 6+ years of experience or
• BS/MS level training with 10+ year experience in clinical pharmacology, pharmaceutical sciences or a related field in the biotech or pharmaceutical industry

Knowledge and Skills

• Experience designing and executing early-phase clinical studies, including healthy volunteer studies
• Strong expertise in PK analysis and exposure-response interpretation
• Experience in assessing impact of various factors on the PK/PD of novel therapeutics and communicating analyses and recommendations to teams
• Familiarity with regulatory guidelines relevant to toxicology/TK, clinical pharmacology and pharmacokinetics
• Knowledge of model-informed drug development, including population PK, PK/PD modeling, and exposure-response
• Proficiency with PK/PD modeling and statistical analysis platforms like Phoenix WinNonlin, Gastroplus, Matlab, Simulations Plus etc.
• Excellent communication, leadership and teamwork skills

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.