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    Senior Medical Director, Early R&I Clinical Development, Rheumatology/Clinical Immunology

    Astrazeneca
    2+ years
    Not Disclosed
    Boston
    10 Oct. 22, 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 Medical Director, Rheumatology/Clinical Immunology
    Location: AstraZeneca

    Introduction to the Role

    Are you ready to shape and deliver the AstraZeneca Immunology pipeline? If you are a motivated drug developer, now is an excellent time to join our team!

    Who We Are

    In the Respiratory and Immunology Early Clinical Development team, we investigate the drivers of key respiratory and immunology diseases, leveraging pioneering science, innovative drug discovery approaches, and collaborations with academic centers worldwide. Our research spans various drug modalities—small molecules, biologics, oligonucleotides, and cell therapies—targeting diseases with high unmet medical need.

    Early Clinical Development in R&I is where science meets clinical drug development, focusing on delivering innovative early-phase clinical studies (Phase 1 – Phase 2b). We collaborate closely with our late-phase clinical development colleagues to guide Phase 3 studies. Our diverse team of experienced physicians and clinical scientists works together to define early-phase clinical development strategies, design innovative clinical trials, develop and validate new clinical endpoints, and translate scientific ideas into proof-of-concept studies in targeted patient populations.

    What You Will Do

    As the Senior Medical Director, you will provide medical and scientific input to preclinical and clinical stage assets focused on Rheumatology/Clinical Immunology. Your responsibilities will include:

    • Leading clinical development in cross-functional teams to support early-phase activities, including creating overall clinical development plans, designing clinical studies, writing protocols, and preparing key study documentation.
    • Ensuring timely delivery of studies while collaborating closely with internal and external partners, including clinical research organizations.
    • Designing, delivering, and interpreting clinical studies to maintain the ethical and scientific integrity of plans and studies in compliance with GCP.
    • Providing guidance on medical strategy and clinical expertise to Research, Translational Medicine, and both Early and Late-stage Clinical Development teams.
    • Monitoring medical developments in autoimmune/inflammatory diseases and disseminating new information to transform trends and emerging data into innovative clinical plans.
    • Collaborating with early and late R&I clinical development and partner functions to ensure high-quality, swift delivery of clinical development plans.
    • Representing Early R&I Clinical Development to external partners, including investigators and patient advocacy groups.
    • Acting as the medical lead for regulatory communications and preparing high-level documents.
    • Ensuring internal and external peer review of potential study/program designs.
    • Supporting the qualification of pharmacodynamic/disease markers for early efficacy assessment.
    • Providing clinical strategic input for in-licensing opportunities as available.

    Basic Qualifications

    • Advanced degree in Rheumatology/Clinical Immunology (MD or PhD).
    • Experience in clinical development within a pharmaceutical or biotechnology setting, particularly in Rheumatology/Immunology, with significant knowledge of clinical trial design and execution in diseases such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
    • Understanding of the entire drug development process, including clinical and non-clinical study design.
    • Thorough knowledge of clinical research methodology and biostatistics principles for innovative trial design and data-driven clinical development plans.
    • Command of FDA, MHRA, and ICH GCP guidelines for conducting global clinical studies.
    • Attention to detail, a strong internal drive for high-quality work, and a sense of urgency to achieve team goals.
    • Demonstrated experience managing complex projects and collaborating with multiple stakeholders.
    • Proven track record of delivering results.
    • Outstanding verbal and written communication skills.
    • Excellent analytical, problem-solving, and strategic planning skills.

    Our Working Environment

    At AstraZeneca, we believe that bringing unexpected teams together unleashes bold thinking, leading to life-changing medicines. Our in-person work model averages three days per week in the office, fostering collaboration while respecting individual flexibility.

    About AstraZeneca

    Join us at AstraZeneca, where we are committed to unlocking the power of science to treat, prevent, modify, and even cure complex diseases. We combine data and technology with scientific innovations to achieve breakthroughs that positively impact billions of patients' lives. Our culture fosters curiosity and courage, empowering you to make bold decisions. We celebrate successes and learn from failures together.

    Ready to Make an Impact?

    Apply now!

    AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds. We welcome applications from all qualified candidates and comply with applicable laws and regulations regarding non-discrimination in employment.

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