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    Director, Pharmacometrics

    Organon
    5+ years
    $150,600.00 - $256,300.00
    California Massachusetts North Carolina Plymouth Meeting
    10 Nov. 24, 2024
    Job Description
    Job Type: Full Time Remote Education: MSc./M. Pharm/PhD 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 Description: Director, Pharmacometrics Lead

    Position Overview

    Location: 100% Remote (US-based)
    Job Type: Regular
    Travel Requirements: Must meet applicable travel and credentialing requirements, including vaccination prerequisites.
    Relocation: Not provided.
    Salary Range (US): $150,600 – $256,300 annually
    Reports To: Senior Leadership

    The Director, Pharmacometrics Lead, is responsible for defining and overseeing program-level modeling and simulation strategies. This includes selecting appropriate modeling vendors, managing vendor relationships, and providing technical oversight. The role emphasizes the integration of model-informed drug development (MIDD) approaches to optimize dose selection and pharmacokinetic (PK) profile assessments. Additionally, the Pharmacometrics Lead contributes to regulatory submissions, clinical documentation, and health authority interactions.

    Key Responsibilities

    1. Modeling & Simulation Strategy

      • Develop and implement program-level modeling and simulation strategies.
      • Oversee vendor selection, onboarding, and management for modeling activities.
      • Author, review, and approve modeling analysis plans, outputs, and summaries.
      • Lead cross-functional discussions on modeling processes and outcomes.

    2. Clinical Development Integration

      • Collaborate with Asset Development Teams (ADTs) to create early clinical development plans.
      • Use MIDD approaches to assess PK profiles, including population pharmacokinetics (PopPK).
      • Optimize dose selection and therapeutic dose confirmation through exposure-response modeling.

    3. Regulatory and Documentation Contributions

      • Serve as the primary author for modeling summaries in module 2.7.2 for regulatory submissions.
      • Contribute to clinical modules, Investigator Brochures, INDs, briefing books, and other regulatory documents.
      • Participate in interactions with health authorities, providing expert insights on pharmacometric strategies.

    4. Translational Strategy Development

      • Support translational aspects of product development in alignment with GLP, GCP, and Organon SOPs.
      • Ensure the integration of pharmacometrics into the broader development strategy.

    5. Stakeholder Communication

      • Engage effectively with regulators, scientific leaders, and medical professionals.
      • Present pharmacometric strategies and findings to internal and external stakeholders.

    Qualifications

    Education & Training:

    • PhD or equivalent degree in pharmaceutics or related sciences.

    Experience:

    • Minimum of 5 years in the pharmaceutical or biotech industry with expertise in pharmacokinetics, pharmacometrics, and clinical pharmacology.
    • Hands-on experience with software platforms such as Phoenix, NONMEM, R, SimCYP, Gastroplus, Monolix, Python, MATLAB, or similar tools.
    • Proven experience with regulatory submissions, clinical submission modules, and agency interactions.
    • Experience in vendor management and oversight for outsourced research activities.
    • Background in global project team environments.

    Technical Expertise:

    • Strong knowledge of pharmacokinetics, pharmacometrics, and clinical pharmacology principles.
    • Familiarity with early clinical development, regulatory guidelines, and GxP standards.
    • Demonstrated ability to integrate complex data into actionable development insights.

    Skills:

    • Leadership qualities including collaboration, integrity, and effective communication.
    • Exceptional organizational and interpersonal skills.
    • Technical writing expertise with the ability to articulate complex ideas clearly.
    • Problem-solving abilities with a focus on solution-oriented recommendations.

    Preferred Experience:

    • Expertise in Women’s Health.

    Company Overview

    Organon is a $6.5 billion global healthcare company focused on improving women’s health and expanding access to leading biosimilars. We deliver innovative health solutions, addressing unmet needs and enhancing lives worldwide. Our vision is a better and healthier every day for every woman.

    Employment Notes

    • Diversity Commitment: Organon is an equal opportunity employer embracing inclusivity.
    • Search Firm Policy: Organon does not accept unsolicited assistance from search firms without a valid written agreement.

    For more details on Equal Employment Opportunity rights, please review:

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