Full-Time

Director – Quantitative Pharmacology and Pharmacometrics Immunology

Posted on 12/20/2024

MSD

MSD

Compensation Overview

$181.6k - $285.8kAnnually

+ Bonus Eligibility + Long Term Incentive

Senior, Expert

H1B Sponsorship Available

Boston, MA, USA + 3 more

More locations: North Wales, PA, USA | San Bruno, CA, USA | Linden, NJ, USA

Hybrid work model requires three days in-office presence per week.

Category
Computational Biology
Biology Lab & Research
Biology & Biotech

You match the following MSD's candidate preferences

Employers are more likely to interview you if you match these preferences:

Degree
Experience
Requirements
  • Ph.D. or equivalent degree with at least seven years of experience OR PharmD or equivalent degree with at least nine years of experience OR MS or equivalent degree with at least 11 years of experience
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, computational biology, chemical/biomedical engineering, or a related field
  • An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry
  • Experience with application of modeling in projects
  • Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
  • Demonstrated ability to participate in and to lead an interdisciplinary team, and to scientifically supervise the work of other scientists
  • Knowledge of clinical autoimmune drug development
Responsibilities
  • Serve as an expert QP2 representative on cross-functional teams of experienced scientists
  • Develop and implement translational PK/PD strategies
  • Characterize clinical population pharmacokinetics and pharmacodynamics of biologics, small molecules, and non-traditional therapeutics
  • Perform clinical trial simulations, comparator modeling, and other model-based analyses to inform dose selection and schedule, clinical trial design, and go/no-go decisions
  • Frame critical drug development questions to optimize drug development using model-based approaches
  • Influence cross-functional teams to adopt model-based strategies
  • Maintain a comprehensive understanding of global regulatory expectations and shape, present, and defend regulatory documents and submissions
  • Develop strategies for quantitative analyses and commensurate experiments/trials within and across development programs and/or departments
  • Collaborate with other functional areas, as well as with external vendors and partners
  • Mentor or supervise early career scientists
Desired Qualifications
  • Ability to influence regulatory strategies including independently formulating registration packages to support global filings
  • Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, Monolix, Phoenix, or similar platforms)
  • Experience with mechanistic modeling frameworks such as PBPK or QSP
  • Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics
  • Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics

Company Stage

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Total Funding

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Headquarters

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Founded

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INACTIVE