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Seattle Genetics
Sr./Principal Clinical Pharmacologist
Clinical Operations - Bothell, Washington
Description
We are seeking a highly motivated Clinical Pharmacologist 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.
Responsibilities:
- Represent Clinical Pharmacology and Pharmacometrics on development project teams.
- Lead the development of clinical pharmacology strategies and the execution of clinical pharmacology studies and exposure-response & population PK/PD analyses.
- 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.
Qualifications:
- An advanced degree (PhD, MD, or PharmD) in pharmacology, pharmaceutical sciences, pharmacy, life sciences, or other related fields.
- 4-6 years relevant experience in the biotech/pharmaceutical industry.
- In-depth understanding of PKPD, drug metabolism and clinical research concepts.
- Strong theoretical background and hands-on experience interpreting clinical dose-response and PKPD data to inform clinical study designs and drug development decision-making.
- Proficiency with WinNonlin, NONMEM, R, MATLAB, or other modeling software.
- Knowledge 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.
Desired:
- Experience with regulatory interactions.
- Experience with oncology and immunology drug development.
- Experience with biologics drug development.
Apply:
Seattle Genetics
Seattle Genetics is an Equal Opportunity Employer
Submitted: 01/19/2018
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