Massachusetts Green Jobs

MassHire JobQuest Logo

Job Information

Biogen Associate Director, Pharmacometrics in Cambridge, Massachusetts

The Associate Director of Pharmacometrics serves as the quantitative pharmacology and pharmacometrics lead on early clinical development teams providing strategic leadership and execution of development plans that include advanced quantitative characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate. This person also provides quantitative rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.

Principle Responsibilities:

  • With minimum supervision drives the development and execution of the Quantitative Pharmacology and Pharmacometric Strategy of clinical development teams. Advises teams on Quantitative Pharmacology and Pharmacometric Strategy and science and provides input to line management. Works with study and clinical development teams to achieve program goals and provide deliverables in approved timeframes.

  • Leads advanced quantitative pharmacology and pharmacometric analyses and activities within assigned programs to yield high value PK/PD support for critical decisions. Interprets and presents results and recommends appropriate actions.

  • With minimum oversight provides insightful regulatory strategy for Quantitative Pharmacology and Pharmacometric support of drug filings and is responsible for the respective sections of regulatory documents. Develops and maintains strong knowledge of best regulatory practices, PK/PD analysis methodology and drug development precedent.

  • Contributes or leads drug modality and drug-disease modeling platform.

  • Engages in cross-functional activities providing Quantitative Pharmacology and Pharmacometric input and scientific opinion to other groups and departments and line management.

  • Develops and maintains scientific awareness and presence in Quantitative Pharmacology and Pharmacometric Science, publishes manuscripts and posters, presents at Scientific Conferences and other scientific forums.

#LI-TG1

  • Demonstrates a strong understanding of: 1) Advanced data analysis and simulation methodologies 2) PK/PD principles, physiology/pharmacology and pathology; 3) operational and scientific aspects of early development studies.

  • Understands and can apply appropriate regulatory and ICH guidelines in the design of all studies.

  • Can manage a diverse, time-sensitive workload.

  • Employs continuous improvement in knowledge and practical understanding of PPDM, Clinical Pharmacology and application of this knowledge in the program team setting.

  • Possesses strong English communication skills requiring minimal oversight in drafting grammatically correct written documents and making oral presentations.

  • Has excellent organizational and interpersonal skills.

Education:

  • Ph.D., M.D./Ph.D., or Pharm.D. in pharmacy, applied pharmacology, pharmacokinetics, biomedical engineering, biostatistics, or a related field.

  • 3+ years of direct industry experience in preclinical and clinical pharmacology, modeling & simulation, and program team support.

  • Some experience in drafting early drug development strategy and designing/implementing studies for multiple compounds including PPDM data analyses for both biologics and small molecules.

Technical / Soft Skills:

  • Experience with use of PK/PD software packages such as - Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS

All your information will be kept confidential according to EEO guidelines.

The Associate Director of Pharmacometrics serves as the quantitative pharmacology and pharmacometrics lead on early clinical development teams providing strategic leadership and execution of development plans that include advanced quantitative characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate. This person also provides quantitative rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered.

DirectEmployers