We are seeking a highly motivated scientist to join the Clinical Pharmacology and Pharmacometrics group at Seattle Genetics, to support the development of innovative antibody-based therapies that improve outcomes for patients with cancer.
- Represent Clinical Pharmacology on development project teams, leading the development of clinical pharmacology strategies and the execution of clinical pharmacology studies
- Conduct PK/PD and exposure-response analyses using pharmacostatistical and relevant state of the art modeling and simulation techniques to support dose selection, trial design, and Go/No-Go decisions
- Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report-writing
- Conduct pharmacokinetic (PK)/pharmacodynamic (PD) and dose-exposure-response analyses to support internal decision-making, regulatory submission documents, and publications
- Provide input on preclinical-stage programs to optimize in vitro & preclinical data supporting the advancement of programs into clinical development and the submission of Investigational New Drug applications
- Contribute to the development of clinical study concepts and protocols, clinical study reports, and relevant components of regulatory submission documents
- Represent Clinical Pharmacology in interactions with and responses to regulatory agencies
- An advanced degree (PhD, MD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields, or a BS or MS degree with 0-6 years relevant experience in the biotech/pharmaceutical industry
- In-depth understanding of PKPD, drug metabolism and clinical research concepts and experience interpreting clinical dose-response and PKPD data
- Understanding of regulatory guidance related to clinical pharmacology
- Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, collaborative, team-oriented setting
- Proficiency with WinNonlin, NONMEM, R, MATLAB, or other modeling software
- Experience preparing regulatory documents and interacting with regulatory agencies
- Familiarity or experience with oncology, immunology, or biologics drug development or clinical trials
As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com.
Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.