Associate Director/Director, Clinical Pharmacology And Pharmacometrics

Associate Director/Director, Clinical Pharmacology And Pharmacometrics
Company:

(Confidential)


Associate Director/Director, Clinical Pharmacology And Pharmacometrics

Details of the offer

Summary: The Quantitative Pharmacology and Disposition (QPD) department at Seattle Genentics is seeking an Associate Director/Director of Clinical Pharmacology and Pharmacometrics with exceptional technical and leadership skills to develop and implement clinical pharmacology and modeling and simulation strategies to advance development of novel oncology drug candidates across various stages of development for multiple modalities including monoclonal antibodies, ADCs and small molecules. This individual will be responsible for the development and implementation of clinical pharmacology and M and S strategies to ensure that the right drug is delivered to the right patient at the right dose and schedule by integrating data from within the department and in collaboration with the Research and Development departments.

This position has the option of being located in our Seattle or South San Francisco office.

Responsibilities:

Work in close collaboration with key stakeholders, define and execute clinical pharmacology and M and S strategy for novel oncology drug candidates
Represent the clinical pharmacology function on development project teams and take accountability for clinical pharmacology deliverables
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, Go/No:Go decisions, regulatory submission documents, and publications
Provide subject matter expertise to inform decisions on key scientific questions
Provide key guidance on regulatory strategies, and present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs
Mentoring and supervising junior staff members
Represent Seattle Genetics in the external scientific environment : influencing partners and regulators in a positive way
Actively participate in departmental leadership
Build collaborative networks internal and external to the company to ensure rapid and successful development of novel drugs
Requirements:

An advanced degree (PhD, MD, or PharmD) with 5+ years of experience in pharmacology, pharmaceutical sciences, pharmacy, biomedical engineering, or other related fields
Expertise in quantitative pharmacology and hands:on modeling and simulation skills using NONMEM, R, Simcyp, SAS, MATLAB and/or other modeling and simulation software. Experience with advanced mechanistic PK/PD models, disease models, PBPK models, quantitative system pharmacology (QSP) models, clinical trial simulation is highly preferred.
Track record of working with health authorities and responding to regulatory questions and knowledge of global regulatory requirements and guidances on quantitative analyses
Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment
Previous record of impact on drug development through quantitative approaches with strong leadership skills and the ability to influence
Substantial understanding of oncology or related field (eg, inflammation, immunology). Experience with both large and small molecule therapeutics is preferred


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