Scientist I, Clinical Pharmacology, Clinical Pharmacology And Pharmacometrics

Biogen Idec Cambridge , MA 02138

Posted 4 weeks ago

Company Description

Job Description

The Clinical Pharmacologist serves as the clinical pharmacology and pharmacometrics lead on clinical study management teams providing execution of development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas. This person also executes and oversees development and application of systems pharmacology models, providing rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. This person will be responsible for the development and advancement of Gene Therapy products within the Biogen Pipeline and will advise on action based upon study results.

Principle responsibilities

  • With appropriate supervision is responsible for providing key components of the Clinical Development Plan (strategy/analysis through final reports) and for providing input and scientific opinion to project teams, line management, and governance bodies.

  • With appropriate supervision leads preclinical and clinical pharmacology study efforts (e.g., study design, protocol concepts/protocols preparation, clinical phase oversight, and reporting) within assigned programs to yield high value PK/PD/DM insight for future critical decisions. Analyzes results, interprets, and recommends action based on study results.

  • With appropriate supervision, leads and advances Gene Therapy pipeline projects into the clinic, and proposes clinical development plans for Gene Therapy.

  • Work with study and program teams to achieve program goals and provide deliverables in approved timeframes.

  • With guidance, identifies program and study-specific issues. Generates potential solutions to issues and proposes those solutions to management and/or study teams.

  • Develops and maintains strong knowledge of best regulatory practices, analytical technology and drug development precedent.

  • With oversight provides insightful regulatory strategy for drug filings and is responsible for Clinical Pharmacology sections of regulatory documents.

Qualifications

  • Demonstrates a strong understanding of and experience in PK/PD principles and quantitative analysis.

  • Has strong understanding of Pharmacokinetics and Pharmacodynamics of Gene Therapies including AAVs and other delivery modalities.

  • Employs continuous improvement in knowledge and practical understanding of Mechanistic/Systems Pharmacology, Modeling and Simulation, Clinical Pharmacology and application of this knowledge in the program team setting.

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

  • Can manage a diverse, time-sensitive workload.

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

  • Has excellent organization and interpersonal skills.

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

M.S. in biomedical engineering, applied pharmacology, pharmacokinetics, or related field with 3+ years of direct industry experience in clinical pharmacology and advanced modeling & simulation. Experience with use of PK/PD software packages such as -Phoenix WinNonlin, SimCYP, NONMEM, Monolix, R, Adapt, MATLAB, SAS

Additional Information

The Clinical Pharmacologist serves as the clinical pharmacology and pharmacometrics lead on clinical study management teams providing execution of development plans that include characterization and prediction of the pharmacokinetics, pharmacodynamics and drug metabolism (PPDM) of the drug candidate in selected preclinical and all clinical areas. This person also executes and oversees development and application of systems pharmacology models, providing rationale for dose regimen selection, safety margin assessment and identification of circumstances where dose adjustment or patient selection/stratification should be considered. This person will be responsible for the development and advancement of Gene Therapy products within the Biogen Pipeline and will advise on action based upon study results.

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


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Scientist I, Clinical Pharmacology, Clinical Pharmacology And Pharmacometrics

Biogen Idec