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Director/Senior Director/Head of Clinical Pharmacology and Pharmacometrics

Seattle Genetics, Inc.

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Location:
Bothell, WA
Posted Date:
7/22/2014
Position Type:
Full time
Job Code:
1403SB-01
Salary:
Required Education:
High school or equivalent
Areas of Expertise Desired:

Job Description

The Head of Clinical Pharmacology and Pharmacometrics will lead the strategy, generation, analysis, interpretation, and reporting of clinical pharmacology data at Seattle Genetics, including communication with US and global regulatory agencies in the areas of clinical pharmacology, pharmacokinetics, and exposure-response (PK/PD, PK/safety, PK/efficacy).
The clinical pharmacology (CP) organization supports all phases of pharmaceutical research and development from IND preparation to clinical development to post-marketing support.  The organization is responsible for defining the relationship between drug exposure and efficacy/safety measures, primary and/or secondary clinical outcomes, and pharmacodynamic biomarkers, in order to select the optimal dose and dosing intervals. CP is also responsible for identifying the intrinsic and extrinsic factors related to the treatment and patient population that may affect drug exposure. CP aids in the selection, design, and interpretation of studies such as first in human, drug interaction, pilot/definitive cardiovascular (QTc), special population, immunogenicity, and ADME studies. The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success. CP provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts.

Major Duties and Responsibilities
This is a leadership position which requires an individual who can aptly manage and represent a functional group.
Responsible for strategic recommendations and/or decisions important to successful nonclinical and clinical drug development including:  1) study designs, 2) data analyses and interpretation, 3) characterization of human PK and ADME, 4) prediction of human PK and PK/PD, 5) characterization and understanding of human PK/PD and pharmacology, 6) identification of first-in-human dose and dose escalation scheme, 7) optimal dose and dosing schedule
Responsible for strategic contributions to the global product development plan, as well as regulatory documents including protocols, CSRs, IBs, IMPDs, IND, CTDs, and BLAs/NDAs.
Responsible for the supervision and development of clinical pharmacology scientists.

Requirements

The Head of Clinical Pharmacology and Pharmacometrics will lead the strategy, generation, analysis, interpretation, and reporting of clinical pharmacology data at Seattle Genetics, including communication with US and global regulatory agencies in the areas of clinical pharmacology, pharmacokinetics, and exposure-response (PK/PD, PK/safety, PK/efficacy).
The clinical pharmacology (CP) organization supports all phases of pharmaceutical research and development from IND preparation to clinical development to post-marketing support.  The organization is responsible for defining the relationship between drug exposure and efficacy/safety measures, primary and/or secondary clinical outcomes, and pharmacodynamic biomarkers, in order to select the optimal dose and dosing intervals. CP is also responsible for identifying the intrinsic and extrinsic factors related to the treatment and patient population that may affect drug exposure. CP aids in the selection, design, and interpretation of studies such as first in human, drug interaction, pilot/definitive cardiovascular (QTc), special population, immunogenicity, and ADME studies. The organization provides critical support for conducting technical due diligence of new business opportunities (both in-licensing and out-licensing) by assessing probability of success. CP provides critical support for life-cycle management of marketed products, responds to questions from post-marketing safety, legal, regulatory for marketed products world-wide, and publication of scientific information in patents and manuscripts.

Major Duties and Responsibilities
This is a leadership position which requires an individual who can aptly manage and represent a functional group.
Responsible for strategic recommendations and/or decisions important to successful nonclinical and clinical drug development including:  1) study designs, 2) data analyses and interpretation, 3) characterization of human PK and ADME, 4) prediction of human PK and PK/PD, 5) characterization and understanding of human PK/PD and pharmacology, 6) identification of first-in-human dose and dose escalation scheme, 7) optimal dose and dosing schedule
Responsible for strategic contributions to the global product development plan, as well as regulatory documents including protocols, CSRs, IBs, IMPDs, IND, CTDs, and BLAs/NDAs.
Responsible for the supervision and development of clinical pharmacology scientists.

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