Principal or Senior Principal Scientist, Clinical Pharmacology, Modeling
Xenon Pharmaceuticals (NASDAQ:XENE) – a biopharmaceutical company with operations in Vancouver, BC, Canada and Boston, MA, USA – is committed to delivering innovative medicines to provide a brighter future for patients suffering from neurological disorders.
At Xenon, we are advancing an exciting pipeline of neurology-focused therapies, with a particular emphasis on novel treatments for both adult and pediatric patients with epilepsy. XEN496 is currently being evaluated in the Phase 3 “EPIK” clinical trial in young patients with KCNQ2-DEE, a rare and severe form of childhood epilepsy. Late-stage development plans are also underway for our XEN1101 program, building upon the compelling data from the Phase 2b “X-TOLE” study in adult patients with focal epilepsy. We are also proud of the leading-edge science coming out of our discovery labs, with many early-stage research programs underway. In addition to Xenon’s proprietary programs, we have ongoing collaborations with our valued pharmaceutical partners. With a healthy balance sheet to support our growth plans, we continue to build a fully-integrated, premier neuroscience company with strong discovery, development, and commercial operations.
Our employees are smart, passionate, dedicated, and driven by their incredibly important work to discover, develop, and deliver new medicines for patients in need. Building and maintaining a respectful, collaborative, inclusive, and productive culture is a priority for us. We are looking for great people who thrive in a fast-paced, dynamic work environment to join our team during this transformative time for Xenon.
We are seeking a Principal Scientist/Senior Principal Scientist, Clinical Pharmacology, Modeling to join our team. This is a regular, full-time position.
The Principal Scientist/Senior Principal Scientist will work flexibly across a variety of projects and have expertise in pharmacokinetics (PK) and pharmacodynamics (PD) modeling particularly physiologically based PK (PBPK) modeling using Simcyp and a proven track record in designing clinical pharmacology studies (e.g., drug-drug interactions (DDI), special population, pediatric and geriatric populations, abuse liability and alcohol tolerance studies) in support of the Company’s IND/CTA and NDA submissions and prescription drug labeling (PDL).
This position reports to the Vice President, Translational Drug Development and will be located in either the Vancouver, BC, Canada or the Boston, MA, USA location.
- Perform non-compartmental analyses (NCA) and compartmental, PK/PD, population PK and PBPK modeling in support of drug development and ensure appropriate data analysis and simulation are performed to support trial design and progression.
- Provide input into clinical pharmacology strategies and plans, including design of clinical pharmacology studies, develop PK analysis plans (PAP) and determine the scope of modeling and simulations required to support Phase 1 to Phase 3 clinical trials and beyond (i.e., Phase 4).
- Review clinical study reports (CSRs), tables, figures, and listings (TFLs), statistical analysis plan (SAS) and other clinical pharmacology components of project plans.
- Author PBPK modeling reports, PK sections of CSRs, regulatory modules, and regulatory documents (IBs, briefing packages, INDs, CTAs, NDAs, etc.).
- Conduct comprehensive analysis of in vitro DDI data to identify data gaps from regulatory and scientific perspectives for both modeling and conducting human DDI studies.
- Provide written responses to regulatory inquires related to PK/ADME, PAP, PK/PD, and other aspects of clinical pharmacology, particularly DDI.
- 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 the scientific aspects of clinical pharmacology study protocol development. Maintain knowledge of relevant scientific and regulatory practices, guidance, and trends, and ensure that clinical pharmacology aspects of development programs are contemporary.
- International travel may be required.
- Recruit, lead, direct, develop, coach, and evaluate direct reports, if any, in accordance with the Company’s Human Resource policies and practices.
- 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 required.
- PhD in pharmacology, pharmacokinetics, pharmacometrics, PharmD, or other professional doctorate in pharmaceutical sciences or a related scientific discipline with minimum 10 years of relevant and direct industry experience.
- Extensive understanding and hands-on experience with modeling and simulation in drug development (i.e., compartmental and NCA, PK/PD, population PK, mechanistic modeling).
- Expert in using modeling and simulation software (e.g., WinNonlin Phoenix, NONMEM, GastroPlus, PKSIM, SimCYP, SAS, R) and good knowledge of statistics. Must be proficient in using SimCYP Simulator and Pediatric Module.
- Thorough knowledge and understanding of the clinical research drug development process, investigational trials, impact of clinical pharmacology content in PDL, and regulatory requirements and filings.
- In depth knowledge and thorough understanding of in vitro DDI both in terms of enzymes and transporters and modeling aspects of these data to predict in vivo human DDI and identify data gaps.
- Expertise in clinical pharmacology trials in pediatric population, in PBPK modeling and simulation and in bioanalytical method development and validation along with handling the bioanalysis aspects of clinical trials are highly desirable.
- Ability to work independently and in multidisciplinary teams with excellent written and verbal communication skills.
- Proficient in oral and written communication in English.