Overview This position is for a Principal Translational Scientist responsible for the design and conduct of Non-clinical Pharmacology and PK/ADME studies across different therapeutic areas. Candidate must have a comprehensive understanding of preclinical pharmacology and PK/PD. Specifically, understanding drug exposure and target engagement, mechanism of action, translation of efficacy models and off-target effects, pharmacokinetics, drug metabolism and transporters. This position is expected to work in a cross-functional team setting and closely collaborate with Noven pharmaceutics, clinical pharmacology and regulatory teams as a subject matter expert in pharmacology and translational science. Skills and commitment essential to the success of this position are participating in early clinical development with a proactive and scientifically inquisitive attitude Responsibilities Design, manage and oversee in vitro or in vivo experiments to determine potency and selectivity of drug candidates Propose and validate novel or alternate therapeutic targets, set up research strategies that encompass target validation and mechanism of action, formulate relevance of results/findings to the clinic Design and manage pharmacology experiments in validated animal models to understand disease mechanism, drug function and patient selection. Design and manage in vitro or in vivo PK and ADME studies to determine pharmacokinetic profile, metabolism and biotransformation pathways. Identify potential for drug interactions or impact of unique metabolites affecting efficacy or safety Establish PK/PD relationship and target exposure, support dose and dosing interval predictions Investigate biomarkers of efficacy, safety and toxicity, set up de-risking strategies if needed Analyze pharmacokinetic/toxicokinetic data to assist in the determination of safety margins and human exposure estimates. Evaluate PK profiles and bioavailability of drug candidates to determine suitability for transdermal route of administration Provide biological rationale and evaluation of potential for TDDS success in alternate indication/population Work with external bioanalytical laboratories to develop and validate appropriate methods to support PK/ADME analyses, and review validation reports. Present, discuss and review data at various internal meetings Prepare integrated nonclinical summaries for regulatory submissions (e.g., CTD summaries, INDs, NDAs, Investigator Brochures, IND annual reports) Qualifications Comprehensive understanding of the principles of PK/PD, animal models and species differences Understanding of strategies to bridgetranslational gap from research phase to early clinical development Excellent written and verbal communication skills, including public speaking, data presentation. Writes and presents effectively; adjusts to fit the audience and the message; strongly gets a message across. Handles issues with drive and energy with an eye on the bottom line; not afraid to initiate action before all the facts are known. Assures compliance with institutional Standard Operating Procedures (SOPs) and Policies, protocol requirements, and institutional reporting requirements. Keep abreast of relevant literature; expertise in dermal/topical formulations as required. Other Elements Education & Experience: M.S. or PhD. in related field or equivalent. At least (4) years of professional experience in pharmaceutical industry or clinical/medical research; involvement in transdermal delivery systems preferred. Knowledge of FDA regulation for drug approval; Knowledge of GLP and ICH Guidelines. Computer literate with intermediate knowledge of office application software. Excellent written and verbal communication skills. Knowledge of software (such as WinNonlin) for PK and PK/PD data analysis preferred Travel: Occasional travel to pre-clinical CROs Work Environment: Office Job ID 2019-1352Salary Range: NAMinimum Qualification5 - 7 years Associated topics: antibody, biomedical, diet, dietary, health, immuno oncology, immunology, microbiology, nutritionist, vaccine
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