PK/PD Scientist/Consultant Position at Isis Pharmaceuticals, Inc.

Title PK/PD Scientist/Consultant (Eq. to Associate Director or Director Level) Employment Type Temporary (Part time to Full Time) Job Description The Pharmacokinetics & Clinical Pharmacology (PK/CP) Department is seeking a highly motivated pharmacokineticist/clinical pharmacologist to support our aggressive and innovative oligonucleotide drug development pipeline. The successful candidate will be supporting preclinical and clinical drug development by providing DMPK, clinical pharmacology and PK/PD expertise across early and late development phases. A strong background and hands on experience in PK/PD modeling and simulation is highly desirable. The candidate will represent the PK/CP Department in cross-functional teams and influence study designs, execution and analysis of DMPK and clinical pharmacology studies. In addition, he/she will support project teams with modeling-and-simulation-based input to clinical trial design, evaluations and integrated data analysis and reporting. Major Responsibilities: 1. Design clinical pharmacology strategy for assigned program and coordinate pharmacokinetic/DMPK related elements for preclinical and/or clinical projects. In addition, identify potential project hurdles, suggest solutions, and establish contingency plans. 2. Perform PK/PD analyses using a variety of methodologies and software tools. Integrate, interpret and report data to project teams, business partners or partner lines. Create, advocate and implement innovative program strategies. Lead the established PK/PD strategy and coordinate activities across projects. 3. Contribute expert input into key pre-clinical, clinical and regulatory documents including clinical study protocols, clinical study reports, PK/PD modeling reports, investigator brochures, IND/IMPD's and NDA's within agreed timelines and meeting all regulatory requirements under minimal guidance from the manager. 4. Monitor timelines, objectives and budgets as appropriate. In addition, assure rapid and effective communication of high-quality data and results to project teams. 5. Lead or participate in PK/CP or project sub-teams and coordinate with appropriate sub-team members and/or prepare summary documentation. 6. Occasionally, support early research in experimental pharmacokinetics. Minimum Qualifications: Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training or equivalent experience 1. At least 6-10 years of relevant postdoctoral, academic, industry, or government experience 2. Expert knowledge of PK/pharmacometrics tools (e.g., WinNonlin, SAS, NONMEM, R, S-Plus, Trial Simulator, GastroPlus and SymCyp, etc.) 3. Expert knowledge of related disciplines (e.g., DMPK, biostatistics, toxicology and regulatory) in the drug development process 4. Demonstrated experience and ability to work successfully as part of cross functional teams in a highly dynamic, matrix and project-team environment 5. Excellent oral and written communication skills 6. Strong organizational and project skills 7. Excellent critical thinking and problem solving skills, including publications/presentations 8. Strong influencing and negotiating skills 9. Coaching, mentoring, and people management skills Please respond with CV and also apply at http://www.isispharm.com. Kenneth T. Luu, Ph.D. Director | PK & Clinical Pharmacology Isis Pharmaceuticals, Inc. | 2855 Gazelle Ct Carlsbad, CA 92010 Office: 760.603.2457 | Fax: 760-603-2502 | Email: [email protected]<mailto:[email protected]> About Isis Pharmaceuticals: Isis Pharmaceuticals, Inc., located in the North San Diego County city of Carlsbad, was founded in 1989 to create advanced, novel medicines to treat complex and challenging diseases. We are the pioneer in the discovery and development of antisense drugs with more than 1200 patents. Isis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in over 20 years and our success is a direct result of our outstanding employees. We are interested in bringing together individuals with different skill sets into this creative environment to be part of a productive team. Join us and experience our unique culture while you develop and expand your career. ________________________________