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    Director, Clinical And Quantitative Pharmacology (Remote)

    Vertex
    10+ years
    Not Disclosed
    Boston 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, Clinical and Quantitative Pharmacology
    Location: Remote-Eligible
    Company: Vertex Pharmaceuticals

    About Vertex Pharmaceuticals

    Vertex Pharmaceuticals is a global biotechnology company committed to advancing scientific innovation and creating transformative medicines for people living with serious diseases. With a strong pipeline and a culture dedicated to groundbreaking science, we are driving breakthroughs in drug development, particularly in areas such as cystic fibrosis and other serious diseases. At Vertex, we invest in our people and foster an environment where scientific curiosity and passion for patients lead to meaningful advancements.

    Role Overview

    Vertex is seeking a Director, Clinical and Quantitative Pharmacology to lead the Modeling and Simulation (M&S) efforts within our drug development programs. This role combines strong pharmacometric expertise with a deep understanding of biological processes, applying advanced modeling techniques to support critical decision-making throughout the drug development lifecycle. The Director will work collaboratively with cross-functional teams to optimize study design, dose selection, and evaluate clinical trial simulations, among other tasks.

    The successful candidate will leverage their expertise in population PK/PD modeling or quantitative systems pharmacology to guide and inform decisions across development programs. Additionally, this role requires effective communication and leadership skills to advocate for model-based approaches and influence drug development strategy.

    Key Responsibilities

    • Modeling & Simulation Leadership: Independently plan, execute, and interpret complex pharmacometric analyses for entire drug development programs, ensuring alignment with overall program strategy.
    • Cross-Functional Collaboration: Collaborate with senior directors in M&S and other functional leaders (e.g., Biostatistics, Clinical Pharmacology) to incorporate quantitative principles in decision-making at key milestones.
    • Regulatory Representation: Represent M&S in regulatory interactions and the preparation of regulatory responses.
    • Methodology Development: Continuously develop and refine M&S methodologies by reviewing the latest scientific literature and incorporating new tools and techniques into the department’s practices.
    • Mentorship: Supervise and mentor junior scientists, fostering their development within the modeling and simulation space.
    • Modeling Activities: Perform population PK/PD analyses, clinical trial simulations, optimal design studies, disease progression modeling, and other model-based analyses.
    • Outsourcing & Vendor Management: Coordinate outsourced M&S activities when necessary, ensuring quality and alignment with program goals.
    • Training & Capability Building: Strengthen the internal M&S capability by leading training initiatives and integrating new tools as needed.

    Preferred Education & Experience

    • Education: Ph.D. in Pharmaceutics, Clinical Pharmacology, or a related quantitative discipline, with a focus on pharmacometric methodologies.
    • Experience: Minimum of 10+ years of industry experience in the application of pharmacometrics to drug development, with expertise in population PK/PD modeling, clinical trial simulations, and optimal design.
    • Technical Skills: Advanced proficiency with pharmacometric software tools such as NonMem, R, Phoenix, SAS, and other relevant tools.
    • Leadership Skills: Proven ability to lead teams, influence key decisions, and collaborate effectively across multidisciplinary teams.
    • Regulatory Experience: Strong understanding of regulatory requirements and experience interacting with regulatory agencies on modeling and simulation-related topics.

    Compensation & Benefits

    • Base Salary Range: $194,400 - $291,600 annually
    • Annual Bonus & Equity Awards
    • Total Rewards Package: Comprehensive benefits including medical, dental, and vision coverage, paid time off, educational assistance programs, student loan repayment, commuting subsidies, 401(k) matching, and more.
    • Flex Designation:
      • Remote-Eligible: Work remotely 5 days a week or opt for Hybrid or On-Site arrangements.

    Vertex Culture & Commitment to Inclusion

    At Vertex, diversity and inclusion are at the heart of our culture. We are committed to creating an inclusive environment where all employees feel valued, respected, and empowered to bring their full selves to work. We welcome applicants from diverse backgrounds and offer accommodations for qualified individuals with disabilities in accordance with applicable law.

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