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    Director – Pharmacometrics, Quantitative Pharmacology And Pharmacometrics (Remote)

    Global Channel Management, Inc
    7+ years
    Not Disclosed
    Remote, USA
    10 Nov. 5, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Director, Pharmacometrics – Quantitative Pharmacology & Pharmacometrics (QP2)
    Location: Remote or Hybrid (depending on location)

    Job Summary

    As the Director of Pharmacometrics within the Quantitative Pharmacology and Pharmacometrics (QP2) department, you will be a key leader driving model-informed drug discovery and development (MIDD) to improve decision-making across the entire drug development pipeline. This role offers an opportunity to lead innovative quantitative approaches such as comparator modeling, model-based meta-analysis (MBMA), and clinical trial simulations (CTS), and mentor a team of talented pharmacometricians. You will have a direct impact on drug discovery, development, and lifecycle management decisions.

    Key Responsibilities

    Leadership & Strategic Direction

    • Lead novel quantitative approaches (e.g., MBMA, CTS) to improve clinical trial design, Go/No-Go decisions, and regulatory outcomes for pipeline programs.
    • Serve as a subject matter expert (SME) in pharmacometrics, fostering collaboration within the QP2 group and across cross-functional teams.
    • Mentor and coach a team of junior pharmacometricians, supporting their professional growth and development in areas like MBMA, comparator modeling, and clinical trial simulations.
    • Contribute to the design and implementation of quantitative strategies impacting pipeline decisions and regulatory submissions.

    Analytical & Technical Expertise

    • Independently develop and apply comparator models across a variety of therapeutic areas, leveraging advanced modeling tools and techniques.
    • Lead and execute MBMA and CTS to inform program development decisions and drive the value of MIDD in decision-making processes.
    • Use expertise in pharmacokinetics and pharmacodynamics to enhance modeling approaches and ensure regulatory success.

    Collaboration & Influence

    • Collaborate with various departments to integrate quantitative analysis into drug development programs.
    • Communicate complex modeling results effectively to both technical and non-technical audiences, including senior leadership, regulatory bodies, and external stakeholders.
    • Lead presentations at key industry conferences and scientific forums, contributing to the company's external visibility.

    Required Qualifications

    • PhD or equivalent degree in Pharmacometrics, Pharmaceutical Sciences, Mathematics, Biostatistics, Computational Biology, Chemical/Biomedical Engineering, or a related field with at least 7 years of experience OR
    • PharmD or equivalent degree with at least 9 years of experience OR
    • MS or equivalent degree with at least 11 years of experience in pharmacometrics or pharmaceutical drug development.
    • Extensive experience performing pharmacometric analyses, including MBMA, CTS, population pharmacokinetics (PopPK), and exposure-response models using NONMEM, R, Monolix, etc.
    • Strong understanding of MIDD and how it drives portfolio and regulatory decisions.
    • In-depth knowledge of drug development, pharmacokinetics, and pharmacology principles.

    Preferred Qualifications

    • Experience in population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic models, and exposure-response modeling using NONMEM, R, Monolix, etc.
    • Demonstrated external visibility in the pharmacometrics field through publications, presentations, and involvement in professional organizations.
    • Proven ability to communicate complex data clearly and effectively, influencing decision-making within cross-functional teams.
    • Demonstrated expertise in developing quantitative strategies that impact pipeline decisions and regulatory submissions.

    Compensation & Benefits

    Expected Salary Range

    • $181,600 - $285,800 (based on experience and location)
    • Bonus eligibility and long-term incentives.
    • Comprehensive benefits package, including healthcare, retirement, paid holidays, and more.

    Work Arrangements

    • This position can be remote or hybrid (depending on location).
    • The Hybrid model requires three days on-site per week, with Fridays designated for remote work (exceptions may apply).

    Equal Opportunity Statement

    We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

    Application Deadline

    • 11/30/2024 (Applications must be submitted by 11:59 PM on this date).

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