Receive alerts when this company posts new jobs.
at Isis Pharmaceuticals
Ionis 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 1600 patents.
Ionis is a challenging, motivating and rewarding environment designed to foster innovation and scientific excellence. Our founding goals have changed little in over 28 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.
ASSOCIATE DIRECTOR, PK/PD
The Pharmacokinetics & Clinical Pharmacology (PK/CP) department is seeking a highly motivated individual to support our aggressive and innovative drug development pipeline. The incumbent will be supporting discovery, preclinical and clinical drug development by providing PK/PD modeling and clinical pharmacology expertise across early and late development phases. The candidate will represent the PK/CP department on cross-functional teams and influence study design and dose selection for animal toxicology and clinical Phase I-III studies.
- Support programs at different stages with modeling and simulation-based input to study design, evaluations, integrated data analysis and reporting.
- Perform PK/PD modeling and exposure/response analysis using a variety of software tools. Integrate, interpret, and report data to project teams and business partners.
- Design and contribute to animal pharmacology, toxicology and clinical pharmacology strategy and studies, lead PK/CP or project sub-teams.
- Contribute expert input into key pre-clinical and clinical, and regulatory documents including study protocols and reports, PK/PD modeling reports, investigator brochures, IND/IMPD's and NDA's within agreed timelines.
- Monitor timelines, objectives and, as appropriate, budgets. Ensure rapid and effective communication of high-quality data and results to project teams.
- Other duties as assigned
- Ph.D. in a relevant discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience
- At least 7 years of PK/PD modeling experience in the pharmaceutical or biotech industry
- Expert knowledge of PK/pharmacometrics tools (e.g., WinNonlin, NONMEM, R, S-Plus, SAS, Trial Simulator)
- Familiarity of related disciplines (e.g., bioanalytics, biostatistics, toxicology, regulatory) in the drug development process
- Demonstrated experience and ability to work successfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment
- Excellent oral and written communication skills
- Strong organizational and project skills
- Excellent critical thinking and problem solving skills
- Successful track record of publications / presentations
- Strong influencing and negotiating skills
- Coaching, mentoring, and people management skills
- An ability to be productive and successful in an intense work environment
Excellent salary and benefits package offered.
For more information on Ionis and to apply for this position, please visit our website,www.ionispharm.com. Reference Requisition #17-0062
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.