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    Global Clinical Program Lead

    Astrazeneca
    5+ years
    Not Disclosed
    Boston
    10 Oct. 24, 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

    Location: Boston, Massachusetts, United States
    Job ID: R-210801
    Date Posted: October 13, 2024

    Make a More Important Contribution

    Join us at AstraZeneca, where you can impact patients’ lives every day. We are committed to expanding our pipeline and growing our capabilities in respiratory and immunology, positioning ourselves as a major player in the field. The Global Clinical Program Lead (GCPL) role in Late Stage Clinical Development is crucial for achieving this ambition.

    What You Will Do

    As a GCPL, you will be responsible for the design, conduct, monitoring, data interpretation, and reporting of clinical trials in respiratory and immunology. Your work will ensure that clinical data accurately assesses the benefits and risks of compounds, aligned with the overall strategy for the clinical development program.

    Typical Accountabilities

    • Study Design and Delivery: Responsible for concept delivery and clinical/scientific decisions within the Global Study Team.
    • Patient Safety Oversight: Ensure compliance with Good Clinical Practice (GCP) while prioritizing patient safety at both study and program levels.
    • Scientific Medical Input: Provide scientific input for all relevant study documents, ensuring consistency and alignment with scientific rationale.
    • Safety Surveillance: Accountable for safety monitoring processes, including Adverse Events (AE) reporting.
    • Collaboration and Support: Engage in investigator meetings and support local Marketing Companies for country-level activities.
    • Team Leadership: Induct and educate new Global Study Team members and contribute to clinical trial improvement initiatives.

    Regulatory Interactions

    • Lead the development of clinical sections for regulatory submissions and respond to inquiries from Regulatory Authorities.
    • Oversee the strategy for regulatory briefing documents and ensure completeness.

    Scientific Medical & Analytical Accountabilities

    • Stay updated on relevant scientific literature and deliver balanced analyses of clinical data to drive interpretations.
    • Build relationships with steering committees and external partners while providing guidance for externally sponsored trials.

    People Management

    • Directly manage 5-8 team members.

    Basic Qualifications

    • Education: MD, MBBS, or equivalent medical degree with board certification in pulmonary medicine.
    • Experience: Minimum of 5 years in the pharmaceutical industry, with expertise in leading late-phase clinical trials.
    • Knowledge: Strong understanding of biostatistics, global regulatory requirements, and pharmacovigilance.
    • Skills: Excellent presentation and communication skills, with experience in writing clinical aspects of regulatory documents.

    Behaviors Required

    • Demonstrated leadership qualities, collaborative working skills, and commitment to AstraZeneca's values and behaviors.
    • Proven ability to work effectively in diverse teams.

    This role is based at our dynamic R&D site in Boston, with a planned move to Kendall Square/Cambridge in 2026. We embrace diversity and are committed to building an inclusive team. We welcome applications from all qualified candidates, regardless of their backgrounds.

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