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    Clinical Scientist Late Stage Oncology - Manager (Clinical Data Review)

    Pfizer
    5+ years
    $99,900–$166,500 per year.
    Bothell Cambridge Collegeville Groton La Jolla New York South San Francisco
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: BA/BS/PhD/PharmD/B.Pharm/M.Pharm 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

    Position Title:

    Late-Stage Clinical Scientist (Non-MD, Manager)
    Therapeutic Area: Late-Stage Oncology

    Role Summary

    The Late-Stage Clinical Scientist (Non-MD, Manager) is responsible for conducting clinical data review to ensure scientific oversight, data integrity, and quality in clinical trials for late-stage oncology programs. This role involves collaboration with cross-functional teams, adherence to global regulatory standards, and maintaining up-to-date knowledge in oncology to contribute to successful clinical trial execution.

    Role Responsibilities

    Data Review & Integrity

    • Perform comprehensive clinical data review to ensure quality, accuracy, and scientific integrity in assigned clinical trials.
    • Review safety and efficacy data, identify emerging trends, and address data inconsistencies.
    • Support the clinical data review strategy in collaboration with medical and clinical colleagues.

    Collaboration & Communication

    • Work closely with clinical operations, medical teams, and other functional lines to ensure the successful implementation and execution of clinical trials.
    • Provide scientific support and insights to cross-functional teams to address clinical trial challenges.
    • Partner with medically qualified colleagues to analyze the emerging safety profile of drugs and communicate updates to relevant stakeholders.

    Compliance & Process Improvement

    • Follow relevant SOPs, ICH-GCP guidelines, and global regulatory requirements to ensure compliance throughout clinical trial processes.
    • Actively participate in organizational initiatives and workgroups to optimize clinical development procedures.
    • Stay informed on industry trends and innovations to improve quality and efficiency in clinical trials.

    Scientific Knowledge

    • Maintain and update knowledge in oncology and specific therapeutic areas related to assigned clinical trials.
    • Contribute to scientific discussions and problem-solving within the clinical development framework.

    Qualifications

    Basic Qualifications

    • Education:

      • PhD, PharmD, or equivalent in a scientific field with a minimum of 1 year of clinical research experience.
      • OR a BA/BS with a minimum of 5 years of clinical research experience in industry/CRO roles.

    • Skills & Experience:

      • Experience in oncology clinical research preferred (industry, fellowship, or academia).
      • Strong knowledge of ICH guidelines, GCP standards, and global regulatory frameworks (e.g., FDA, EMA).
      • Proven ability to conduct clinical data review and work with large datasets.
      • Strong organizational, communication, and presentation skills.
      • Demonstrated proficiency in scientific writing and publishing.
      • Technical proficiency with IT tools and data analysis platforms.

    Preferred Qualifications

    • A global mindset and ability to work effectively in diverse, multicultural teams.
    • Proficient in digital tools for collaboration (telecommunications, video conferencing).
    • Strong problem-solving and decision-making skills in clinical settings.
    • Embraces innovation and takes initiative to improve clinical trial efficiency.
    • Proven track record of collaboration and adaptability in dynamic work environments.

    Work Environment

    • On-site presence required for an average of 2.5 days per week.
    • Flexible and adaptable to changing clinical trial needs while maintaining high-quality output.

    Compensation & Benefits

    • Base Salary Range: $99,900–$166,500 per year.
    • Eligible for:
      • Pfizer’s Global Performance Plan (15% bonus target).
      • Long-term share-based incentive program.
      • Comprehensive benefits package, including:
        • 401(k) plan with Pfizer Matching Contributions.
        • Paid vacation, personal, holiday, caregiver, and parental leave.
        • Medical, dental, vision, and prescription drug coverage.

    Pfizer as an Employer

    Pfizer is committed to equal employment opportunities, promoting a diverse and inclusive workplace, and complying with global employment eligibility regulations. Join Pfizer to help advance oncology treatments and improve the lives of patients worldwide.

    For more information, visit Pfizer's U.S. Benefits website at uscandidates.mypfizerbenefits.com.

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