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    Director, Clinical Pharmacology

    Iqvia
    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: Senior Clinical Pharmacokineticist (PK/PD) - Remote (US/Canada)
    Location: Remote-based (US or Canada)
    Company: IQVIA - Data Sciences Staffing Solutions (DSSS)

    About DSSS (Data Sciences Staffing Solutions)

    Data Sciences Staffing Solutions (DSSS) is a specialized unit within IQVIA that provides fully dedicated resources to our sponsor clients through a Functional Service Provider (FSP) partnership. This means you will have the best of both worlds: working for a global leader in the clinical research industry while being embedded within sponsor teams and utilizing sponsor systems. Our clients include world-class pharmaceutical and biotech companies, offering you a unique opportunity to contribute to cutting-edge clinical development projects. In this role, you’ll be a critical part of a dynamic team that is shaping the future of healthcare and advancing innovative therapies.

    As part of DSSS, you won’t just be another team member — you'll play a vital role in reshaping the future of medicine alongside passionate colleagues.

    Why DSSS?

    • Home-based remote work opportunities
    • Excellent work/life balance
    • Collaborate with industry leaders in Pharma and CRO sectors
    • A cohesive, collaborative team environment
    • Exposure to a variety of therapeutic areas and study phases
    • Job stability with long-term engagements and development opportunities
    • Career advancement possibilities

    Key Responsibilities

    As a Senior Clinical Pharmacokineticist (PK/PD), you will be responsible for providing expert contributions to the design, analysis, and reporting of clinical pharmacology studies. Your key responsibilities will include:

    • Develop and review protocols, statistical analysis plans, PK/PD tables, listings, figures, and clinical study reports for Phase I-IV clinical pharmacology studies, including dose tolerance, bioavailability, drug-drug interactions, and population PK/PD studies.
    • Consult with clients’ Clinical Pharmacology teams to assist in study design and contribute to clinical development plans.
    • Review analytical data and documents prepared by CROs to ensure quality, accuracy, and alignment with study objectives.
    • Prepare and review the PK/PD sections of dossiers for product registration, ensuring regulatory compliance and communicating with regulatory agencies.
    • Ensure timely and accurate delivery of PK/PD deliverables for clinical trials.
    • Work collaboratively with cross-functional teams, including Project Managers, Clinical Research Associates (CRAs), Data Managers, Biostatisticians, Programmers, and Medical Writers to support study progress.
    • Stay updated on advancements in clinical pharmacology, PK/PD, and relevant literature to ensure the application of current best practices.

    Education & Experience

    • PharmD, Ph.D., or Master’s degree in Pharmacy, Pharmaceutics, or related field in Pharmacokinetics required.
    • 10+ years of experience in Pharmacokinetics, Pharmaceutics, or related fields within Clinical Research Organizations (CROs) or pharmaceutical environments.
    • Strong knowledge of PK concepts, including noncompartmental analysis, population PK modeling, and trends in drug development.
    • Expertise in the drug development process and ICH GCP guidelines, as well as national and international regulatory requirements.
    • Proficiency with Microsoft Office, WinNonlin, NONMEM, R, and SAS programming.
    • Excellent verbal and written communication skills, with a demonstrated ability to interact with cross-functional teams and regulatory agencies.
    • Strong analytical and problem-solving skills, with the ability to manage complex PK/PD project components independently.

    Additional Skills

    • Ability to prioritize tasks in a fast-paced environment with changing priorities.
    • Demonstrated success working within a cross-functional, multi-cultural team environment.
    • Strong interpersonal skills with the ability to establish and maintain effective working relationships with colleagues and clients.

    Compensation & Benefits

    • Base salary range: $140,400 - $260,700 (annualized), depending on experience and location.
    • Additional incentive plans, bonuses, and benefits offered, including comprehensive healthcare, 401(k) match, paid time off, and more.

    Why Join IQVIA?

    At IQVIA, we are committed to accelerating the development and commercialization of innovative medical treatments. As a leading global provider of clinical research services and healthcare intelligence, we create intelligent connections to improve patient outcomes and enhance population health worldwide. Working with us means shaping the future of healthcare.

    IQVIA is an Equal Opportunity Employer
    We are committed to creating an inclusive environment and providing equal employment opportunities to all candidates. We encourage applicants from diverse backgrounds, including veterans and those with disabilities.

    For more information, visit IQVIA Careers

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