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Associate Scientist/Scientist DMPK-Clinical Pharmacology

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Cambridge, MA

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Job Description
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Job Code
586
# of openings
1
Associate Scientist/Scientist, DMPK-Clinical Pharmacology
Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has one approved oncology precision medicine and multiple first-in-class investigational therapies in clinical and/or preclinical development.

The DMPK-Clinical Pharmacology Department at Agios is seeking a dedicated clinical pharmacokinetics (PK) and pharmacodynamics (PD) scientist. This individual will have a range of responsibilities within the department, including performing PKPD analysis and correlation analysis, data QC and formatting, and study coordination. This person will also represent the function to clinical trial working groups (CTWG) and ensure effective and timely support to clinical pharmacology studies and/or patient trials. This will be accomplished by working in close partnership with senior clinical pharmacologists and other DMPK colleagues, as well as by establishing and developing strong relationships with other key cross functional partner functions such as Clinical operations, Clinical Development, Medical writing, Safety, Biostatistics etc.

The qualified candidate must have basic PK and PKPD data analysis skills and must be proficient in conducting these analyses using WinNonlin and Excel. NONMEM dataset formatting and other statistical programming skills are highly preferred. The qualified candidate is also expected to be detail oriented and with excellent communication and interpersonal skills.

Key Responsibilities
Performing PK and PKPD analysis for clinical studies
Conduct data QC and formatting for PK and PKPD reports and other documentations
Coordinating Clinical pharmacology and/or other studies
Represent Clinical pharmacology to clinical trial working groups (CTWG), contribute to clinical trial design, protocol, trial execution/coordination, and CSR.
Managing CROs for Clinical pharmacology related studies and activities
Minimum Requirements
Minimum 3 years of industry experience working as an associate scientist or scientist in clinical or preclinical DMPK areas
Proficient in non-compartment PK and PKPD analysis using WinNonlin
Experienced in QC of PK or PKPD data
Background in mathematics, statistical programming and data analytics is a plus
Database management and study tracking/coordination is a plus
Advanced training in WinNonlin, WinNonmix, R, SAS, and NONMEM is a plus
Working experience in bioanalysis, DMPK, and PKPD areas is a plus
Must excel at working in a highly collaborative team environment, and have good organizational, communication, and interpersonal skills
Preferred Qualifications
Education: BS or MS degree in pharmacokinetics, mathematics, bioengineering/chemical engineering or related areas with minimal 3 years of relevant biotech/pharmaceutical experience.
PI103351247
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