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    Director – Pharmacometrics, Quantitative Pharmacology And Pharmacometrics (Remote)

    Global Channel Management, Inc
    10+ years
    $181,600 - $285,800 annually
    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 and Pharmacometrics
    Location: Remote-Eligible
    Company: Merck & Co., Inc.

    About Merck

    Merck & Co., Inc. is a global healthcare leader that is committed to delivering innovative medicines and vaccines that address unmet medical needs. Our focus spans several key therapeutic areas, including oncology, immunology, and infectious diseases, as well as groundbreaking research in areas like diabetes and cardiovascular disease. Through cutting-edge scientific discovery, Merck is striving to advance global health.

    Role Overview

    The Director – Pharmacometrics, Quantitative Pharmacology and Pharmacometrics will play a pivotal leadership role in driving Model-Informed Drug Discovery and Development (MIDD) across Merck’s drug development pipeline. The Director will utilize advanced modeling techniques to provide key insights that inform drug development decisions, ranging from early discovery through to life-cycle management. This includes comparator modeling, model-based meta-analysis (MBMA), and clinical trial simulations (CTS). In addition, the Director will oversee and mentor a talented team of pharmacometricians, fostering a collaborative environment while driving innovation and continuous improvement in MIDD capabilities.

    This role offers the opportunity to directly influence critical decision-making in Merck’s drug development programs, working closely with scientists across multiple disciplines and therapeutic areas. The Director will leverage extensive pharmacometric expertise to enhance the company’s portfolio and regulatory strategy.

    Key Responsibilities

    • Leadership in MIDD: Identify, develop, and implement novel quantitative approaches to improve drug development processes, including clinical trial design, Go/No Go decisions, and overall cycle time.
    • Strategic Impact: Serve as a subject matter expert, collaborating across functions to integrate model-based approaches such as MBMA into the decision-making process for drug programs.
    • Mentorship & Coaching: Mentor and guide junior pharmacometricians, ensuring continuous development of their skills and capabilities in pharmacometrics.
    • Modeling Expertise: Independently develop and deploy comparator models and other advanced pharmacometric methodologies to support drug discovery and regulatory decisions.
    • Collaboration & Communication: Foster strong interdisciplinary collaborations and communicate complex modeling results effectively to stakeholders at all levels, including senior management and regulatory bodies.
    • Continuous Improvement: Drive the integration of new tools and methodologies, building the organization’s pharmacometric capability for future pipeline success.

    Required Experience

    • Education:
      • Ph.D. or equivalent in pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or related fields.
      • Alternatively, a PharmD or MS with relevant experience may be considered.
    • Experience:
      • At least 7 years of experience with a Ph.D., 9 years with a PharmD, or 11 years with an MS in a similar role within pharmaceutical drug development or academia.
      • Proven expertise in model-based meta-analysis (MBMA) and clinical trial simulations (CTS) using pharmacometric software tools (e.g., NONMEM, R, Monolix).
      • Deep understanding of pharmacokinetics, pharmacodynamics, and drug development principles, with the ability to influence regulatory and portfolio decisions.
    • Leadership:
      • Demonstrated ability to lead and mentor a team of pharmacometricians, driving individual and team development in a collaborative, goal-oriented environment.

    Preferred Experience

    • Advanced Modeling: Experience with population pharmacokinetics (PopPK), pharmacokinetic/pharmacodynamic models, exposure-response models, and other advanced pharmacometric methodologies.
    • External Visibility: Proven track record of publications, presentations, or involvement in professional pharmacometrics organizations.
    • Communication Skills: Exceptional written and verbal communication skills, with the ability to present complex data and strategies to a broad audience, including regulatory agencies.

    Compensation & Benefits

    • Base Salary Range: $181,600 - $285,800 annually
    • Bonus Eligibility & Long-Term Incentive Plans
    • Comprehensive Benefits Package including health insurance, retirement savings, paid time off, and more.
    • Work Arrangement: Remote-Eligible with flexibility in working hours.

    Company Commitment to Diversity & Inclusion

    Merck is committed to fostering a diverse and inclusive work environment. We encourage applicants from all backgrounds and ensure that all qualified individuals are given equal consideration for employment, without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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