- Perform non-compartmental analyses (NCA) and compartmental modeling and create reports, figures, tables, and power point presentations in support of drug development and clinical trial progression.
- Participate in clinical pharmacology study design, develop PK analysis plans (PAP) and determine the scope of modeling and simulations required to support Phase 1 studies.
- Review tables, figures and listings (TFLs), statistical analysis plan (SAP) and other clinical pharmacology components of project plans.
- Conduct in vitro ADME studies and perform comprehensive analysis of in vitro ADME and DDI data to identify data gaps from scientific perspectives for both modeling and conducting human DDI studies.
- Lead bioanalytical method development and validation (BioA method D&V) and the bioanalysis aspects of clinical trials along with managing BioA CROs.
- Write scientific publications (posters, peer-reviewed manuscripts, etc.) and prepare/give scientific presentations consistent with development strategies and publication plans.
- Collaborate with toxicology team on BioA method D&V, bioanalysis and toxicokinetic data analysis.
- Maintain knowledge of relevant scientific and regulatory practices, guidance, and trends, and support senior clinical pharmacologist on various aspects of development programs as needed.
- Perform and/or assist in conducting PBPK modeling in support of drug development.
- International travel, between Canada and USA, within Canada or USA may be required.
- Act in accordance with Company policies, including, for example, the Code of Business Conduct and Ethics and ensure policies are understood and followed by direct reports, if any.
- Other duties as assigned.
- PhD in pharmacology, pharmacokinetics, pharmacometrics, PharmD, or other professional doctorate in pharmaceutical sciences or a related scientific discipline with minimum 2 years of post-doctoral experience and/or relevant industry experience.
- Extensive understanding of PK principles, good knowledge of statistics and hands-on experience with modeling and simulation in drug development (i.e., compartmental and NCA, PK/PD, mechanistic modeling).
- Expert in using WinNonlin Phoenix. Proficiency or familiarity with Simcyp, NONMEM, other related PK software and/or R or similar programming languages is highly desirable.
- Thorough knowledge and understanding of the clinical research drug development process and adequate knowledge of investigational trials.
- Comprehensive understanding and in-depth knowledge and of in vitro DDI both in terms of enzymes and transporters.
- Intimate knowledge and thorough understanding of basic principles of chromatography, the criteria for BioA method D&V and acceptance of BioA results generated during the bioanalysis of clinical trials.
- Ability to work independently and in multidisciplinary teams with excellent written, verbal, and logical communication skills.
- Must be proficient in oral and written communication in English.
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Scientist 1 or 2, Clinical Pharmacology - Boston, United States - Xenon Pharmaceuticals Inc.
Description
Who We Are:
Xenon Pharmaceuticals (
NASDAQ:
XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.
We are looking for great people who thrive in a respectful, collaborative, inclusive, and productive culture to join the Xenon team.
What We Do:
We are advancing an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship XEN1101 program represents the most advanced potassium channel modulator in clinical development for multiple indications.
Building upon the positive results and compelling data from our XEN1101 Phase 2b "X-TOLE" study in adult patients with focal epilepsy, our XEN1101 epilepsy program includes multiple Phase 3 clinical trials in patients with focal onset seizures and primary generalized tonic clonic seizures.
In 2024, we are planning to initiate a Phase 3 XEN1101 program in major depressive disorder, based on topline data from our XEN1101 Phase 2 "X-NOVA" clinical trial.
In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.
Backed by a strong balance sheet to support our growth plans, we continue to build a fully integrated, premier neuroscience company with strong discovery, clinical development, corporate, and commercial operations.
About the Role:
We are seeking a Scientist 1 or 2, Clinical Pharmacology to join our team. This is a regular, full-time position.
The scientist will work flexibly across a variety of projects and have expertise or proficiency in Pharmacokinetics (PK)/pharmacodynamics (PD) including PK study design, data analysis, data review and bioanalysis in support of the Company's pipeline, IND/CTA and NDA submissions.
Proficiency or familiarity with PK/PD modeling and physiologically based PK (PBPK) modeling is highly desirable.This position reports to the Senior Director, Clinical Pharmacology, Modeling and will be located in Boston, MA, USA. The level of the position will be commensurate with the candidate's education and industry experience. Relocation and immigration support will be provided, if required.
RESPONSIBILITIES:
QUALIFICATIONS:
The base salary range for this role is $90,000 to $117,900 USD; we will consider above this range for exceptional candidates.
Base salary is determined by a combination of factors including, but not limited to, education and other qualifications, years of relevant experience, and internal equity.
Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
To apply for this position, click Apply Now to complete the application.We thank all applicants for their interest; however, due to the volume of applicants, only those chosen for interview will be contacted.
Apply Now
