Position: Associate Director/Director Department: Pharmacokinetics and Clinical Pharmacology Job Code: 346.0311.1.RL
XenoPort, Inc. is a biopharmaceutical company focused on developing a portfolio of internally discovered product candidates that utilize the body's natural nutrient transport mechanisms to improve the therapeutic benefits of existing drugs. We are currently seeking a talented individual to join XenoPort, Inc as a Clinical Pharmacology/Pharmacokinetics Associate Director/Director. This individual would, apply high medical, scientific and ethical standards to study designs to define the pharmacokinetics and clinical pharmacology of investigational drugs for assigned portion(s) of the clinical plan while adhering to all relevant regulatory requirements. Responsibilities: Responsibilities will include the use of predictive simulations to guide project development plans, and preparation of relevant sections of documents (protocols, study reports, Investigator Brochures, briefing documents, and IND/NDA submissions). They will be responsible for the design, data analysis, and interpretation of pharmacokinetic , toxicokinetic, and pharmacodynamic aspects of preclinical and clinical studies. They will also oversee the design and interpretation of appropriate PK studies and integrate findings from in vitro stability and in vivo PK. Perform non-compartmental, compartmental, and population pharmacokinetic-pharmacodynamic modeling of clinical and non-clinical data The candidate must be able to interact well within a team setting (e.g. with representatives of clinical groups, project management, toxicology, bioanalytical, , regulatory affairs, drug safety). They will be a hands-on, multi-tasking scientist with excellent written and verbal communication skills, capable of interacting with all levels of the company, advisors, partners, investors, etc. Consults as needed across discovery research and clinical efforts to provide appropriate pharmacokinetic and clinical pharmacology input and focus to projects and programs at all stages The candidate will assist in the overall clinical pharmacology study planning, management, evaluation, and documentation. Assist or lead in full protocol development and participate in study management. Provide clinical scientific input for final study reports and annual report documentation. Knowledge of clinical pharmacology and relevant biological and medical concepts and be able to handle the pharmacokinetic and pharmacodynamic analysis, interpretation and reporting of a clinical pharmacology study. They will provide clinical pharmacology expertise to determine and execute a cost-effective rapid drug development program. This should include the minimum number of studies necessary to make all the necessary internal decisions (e.g. go/no go, dosage in phase II) and ultimately to submit an NDA with the Clinical Pharmacology and Human Pharmacokinetics and Bioavailability sections of the NDA documents supporting approvable and marketable claims. Responsible for the timely preparation and quality of relevant documents (protocols, final study reports, IND and NDA summaries) or contributions to documents (INDs, NDA expert reports) * Review of CRFs produced for Clinical studies. Works on operational aspects including evaluation of Clinical Pharmacology Units, investigators with regards to study planning, placement and conduct. Responsible for the evaluation of Clinical Pharmacology data (pharmacokinetics, pharmacodynamics) from clinical studies, interacting as required with Operational staff, Data Management, Biostatistics, Toxicology, Regulatory, and other partners. * Interacts with regulatory authorities with regards to Pharmacokinetics and Clinical Pharmacology issues. Qualifications and Other Required Knowledge and Skills: * Ph.D. , M.D. or Pharm D. degree in an area relevant to pharmacokinetics and clinical pharmacology, and typically ten or more years of relevant preclinical, clinical and pharmaceutical industry experience. * Experience in the planning and conduct of Clinical Pharmacology trials. * Appropriate modeling and computer software experience. * Excellent communication and presentation skills. * In-depth knowledge of PK and PD evaluation techniques using standard tools (WinNonlin, ADAPT II, etc.) and their practical application to drug development, experience writing relevant sections of regulatory filings. * Familiarity with applicable FDA guidelines is required. * Knowledge of population PK/PD modeling (NONMEM, S-PLUS.) is a benefit, as are previous experience with CYP450 inhibition/induction studies, IVIVC evaluation, and drug interaction, special populations studies. To apply, please follow the URL: https://apps.irecruit-us.com/82/application.php?OrgID=I20110209&RequisitionID=34603111RL&JobID=34603111RL ##################################################################################### The information contained in this email message, including attachments, is the confidential information and/or property of XenoPort, Inc. This email message is for the sole use of the intended recipient(s). Any unauthorized review, use, disclosure or distribution is prohibited. If you are not the intended recipient, please contact the sender by reply email and destroy all copies of the original message. #####################################################################################
