Principal Investigator, Pharmacokinetics and Clinical Pharmacology

We are looking for a talented individual to join XenoPort, Inc as a Clinical Pharmacology expert, applying high medical, scientific and ethical standards to study designs to assist the Clinical Pharmacologist to efficiently define the clinical pharmacology of investigational drugs for assigned portion(s) of the clinical plan while adhering to all relevant regulatory requirements.  The successful candidate will be a hands-on, multi-tasking scientist with excellent written and verbal communication skills, capable of interacting with all levels of the company colleagues, advisors, and partners, and consult as needed across discovery research efforts to provide appropriate clinical pharmacology input and focus to projects and programs at all stages.

 

 Responsibilities:Participate in the overall study planning, management, evaluation, and documentation. Provide scientific expertise for the planning, design, data analysis and interpretation, and reporting of clinical PK/PD studies and regulatory dossiers to support the clinical development and registration of company lead candidates.Work on operational aspects including evaluation of Clinical Pharmacology Units and investigators with regards to study planning, placement and conduct.

· Review and provide input on CRFs and TLFs generated for clinical studies. 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.

· 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)

· Interact with regulatory authorities with regards to 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 five or more years of relevant clinical and pharmaceutical industry experience. 

· Experience in the planning and conduct of Clinical Pharmacology trials.

· Appropriate modeling and computer software experience.

· Good command of spoken and written English with excellent communication and presentation skills

· Able to interact well within a team setting (e.g. with representatives from clinical groups, project management, preclinical research, regulatory affairs, drug safety). · 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 studies.

 

XenoPort, Inc. is always looking for talented individuals that will make a difference. We offer outstanding candidates an excellent compensation and benefits package including stock options. Xenoport is an Equal Opportunity Employer.