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Director, Pharmacometrics

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Company: Agios Pharmaceuticals

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Agios (agios.com) is a biopharmaceutical company committed toapplying our scientific leadership in cellular metabolism totransform the lives of patients with cancer and rare geneticdiseases. We are growing rapidly with an active research anddiscovery pipeline across both therapeutic areas. Agios has twoapproved oncology precision medicines and multiple first-in-classinvestigational therapies in clinical and/or preclinicaldevelopment.

Lead diverse DMPK-Pharmacometrics team, including peoplemanagement, talent development, recruiting and portfoliomanagement

Develop and execute scientifically rigorous pharmacometricstrategy to inform major drug development and regulatory decisionsthrough all phases of drug development

Represent the pharmacometric discipline as a thought leader,utilizing state-of-the-art approaches to accelerate programprogression and address critical program issues, leveraging dataand outcomes modeling and simulation, biostatistics, and machinelearning approaches as applicable.

Plan, implement, and execute pharmacometrics objectives,including population analysis, PKPD modeling/simulation,exposure-response, concentration-QTc, and NCA analyses for allclinical programs and discovery projects.

Partner with DMPK, Biotransformation and Clinical pharmacologyin modeling based dose selection for adult, pediatric, anddifferent disease populations using population PK and/or PBPKtools

Partner with cross functional teams for daily operation and tooptimize work flow and data standardization to further improveefficiency.

Oversee pharmacometrics related CRO activities and externalconsultant network

Contribute to global regulatory filings including preparation ofregulatory documentation and participation in meetings withregulatory agencies

Leverage disciplinary excellence and visibility to provideAgios’ external face for industry leading pharmacometricsapplication to drug discovery and development

PhD or equivalent in medical/pharmaceutical sciences,engineering or related field with at least 10 years of relevantexperience including experience in a leadership role.

Experience leading and applying pharmacometric approaches suchas population PK, PKPD, and disease progression models to supportresearch and development

Excellent quantitative skills and expertise with a range ofmodeling software such as NONMEM, WinNonlin, and R

Broad familiarity with the drug development process

Able to perform independently in a fast-paced environmentmanaging multiple priorities simultaneously

Excellent interpersonal and communication skills both writtenand oral and ability to communicate complex informationsuccinctly

Strong collaborative skills and ability to influence othersthrough effective presentations

Excellent analytical and problem solving skills

Preferred Qualifications

Prior experience working with pharmacometric CROs

Knowledge and experience in clinical pharmacology, drugmetabolism, and drug-drug interaction areas

Experience in oncology and/or rare genetic disease areas

Background and knowledge in biostatistics and familiar with SASprogram

Keywords: Agios Pharmaceuticals, Cambridge , Director, Pharmacometrics, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Director, Pharmacometrics, Other , Cambridge, Massachusetts

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