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    Director , Clinical Research (Md Required)- Immunology, And Inflammation

    Pfizer
    2+ years
    $213,500–$355,800 PER ANNUM
    Cambridge
    10 Nov. 23, 2024
    Job Description
    Job Type: Full Time Education: MD/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

    Position Title:

    Director of Clinical Research
    Therapeutic Area: Immunology and Inflammation

    Role Summary

    The Director of Clinical Research leads and coordinates the development of early-phase clinical studies, including first-in-human (FIH), proof of mechanism (PoM), proof of clinical activity (SoCA), proof of concept (PoC), and dose-ranging studies for innovative biological and small molecule therapies in Immunology and Inflammation programs. The role involves clinical trial design, implementation, data interpretation, and ensuring seamless transitions from early-stage to late-stage development.

    Role Responsibilities

    Clinical Trial Design & Strategy

    • Design PoM, SoCA, and PoC studies in collaboration with KOLs and cross-functional project teams (e.g., Statistics, Clinical Pharmacology, Regulatory).
    • Develop primary/secondary efficacy and safety endpoints aligned with precision medicine and biomarker strategies.
    • Contribute to the statistical analysis plan to align with target product profiles.
    • Establish a network of consultants and KOLs for emerging indications.

    Study Oversight & Implementation

    • Lead study start-up and delivery of PoM, SoCA, and PoC trials, ensuring clinical strategies are implemented and milestones met.
    • Serve as the primary investigator liaison for protocol-related issues and conduct study site visits as necessary.
    • Maintain safety oversight, including regular reviews of safety data and responding to safety issues.

    Collaboration & Team Leadership

    • Collaborate with Early Clinical Development (ECD) and project teams to transition assets seamlessly to Phase 3 development.
    • Work closely with partners in Discovery, Preclinical, Clinical Pharmacology, Bioanalytics, and Statistics to ensure program success.
    • Foster a collaborative and transparent environment to build trust across teams and drive innovation.

    Regulatory & Documentation

    • Lead the development of critical documents, including clinical protocols, clinical development plans, investigator brochures, and regulatory submissions.
    • Maintain up-to-date knowledge of relevant scientific and clinical literature and regulatory guidelines.

    External Engagement

    • Develop and manage relationships with external experts, consultants, opinion leaders, regulators, and disease-specific investigator networks.
    • Represent Pfizer at industry meetings and forums to strengthen visibility in the immunology and inflammation research space.

    Strategic Initiatives

    • Participate in strategic assessments of the Immunology and Inflammation Research Unit (I&I RU) portfolio and contribute to business development activities.
    • Collaborate with Late-Stage Development colleagues to design the Phase 3 strategy and analyze PoC data.

    Qualifications

    Education & Experience

    • MD or MD/PhD with specialization in Rheumatology, Allergy, Pulmonary, Hematology, or Dermatology.
    • Minimum 2 years of experience in biopharmaceutical-sponsored clinical research.
    • Experience as a medical monitor or clinical lead across therapeutic areas is highly desirable.

    Skills & Competencies

    • Proficiency in hypothesis-driven research and ability to analyze complex datasets.
    • Strong knowledge of biostatistics, regulatory guidelines, pharmacogenomics, and biomarker strategies.
    • Demonstrated scientific productivity (e.g., publications, abstracts, presentations).
    • Effective communication, scientific writing, and presentation skills.
    • Proven ability to work in a matrixed, fast-paced environment with a sense of urgency.

    Preferred Skills

    • Familiarity with preclinical toxicology and systems immunology.
    • Experience collaborating with global and cross-functional teams.
    • Leadership and problem-solving capabilities to address clinical trial challenges.

    Work Environment

    • Full-time position eligible for relocation assistance based on business needs.

    Compensation & Benefits

    • Annual Base Salary Range: $213,500–$355,800.
    • Eligible for:
      • Pfizer’s Global Performance Plan (25% bonus target).
      • Share-based Long-Term Incentive Program.
      • Comprehensive benefits package, including:
        • 401(k) plan with Pfizer Matching Contributions.
        • Paid vacation, personal, holiday, caregiver, and parental leave.
        • Medical, prescription drug, dental, and vision coverage.

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

    Pfizer as an Employer

    Pfizer fosters an inclusive, collaborative, and innovative environment, ensuring equal opportunity for all employees regardless of race, gender, religion, or disability status.

    Join Pfizer to lead innovative research and shape the future of Immunology and Inflammation therapies.

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