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    Clinical Research Director - Dermatology

    Sanofi
    7+ years
    Not Disclosed
    Cambridge
    10 Dec. 10, 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

    Clinical Research Director - Immunology & Inflammation (I&I) Therapeutic Area
    Location: Cambridge, MA

    About the Job
    Are you ready to make an impact in shaping the future of medicine? The race is on to accelerate drug discovery and development to provide critical answers for patients and their families. Your expertise could be pivotal in helping our teams drive this progress forward.

    Our Team
    The Clinical Research Director (CRD) in the Immunology & Inflammation (I&I) Therapeutic Area is responsible for creating and executing clinical development plans that align with the project strategy. This role requires collaboration with various departments, including clinical operations, regulatory affairs, and biostatistics, while advancing scientific and clinical knowledge in immunology and dermatology.

    Main Responsibilities

    • Develop and document the clinical development strategy for one or more assets in collaboration with the global project team, including clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, and marketing.
    • Lead and review the clinical development plan (CDP) through internal management reviews.
    • Lead a clinical subteam to design and create clinical study protocols (abbreviated and full protocols).
    • Oversee the execution of clinical studies, ensuring compliance with internal SOPs, GCP, ICH guidelines, and relevant regulations.
    • Review and contribute to key clinical documents, including Investigator’s Brochures, regulatory documents for IND/CTA, integrated development plans, and submission dossiers.
    • Support drug registration processes, including submission dossiers, label drafts, and regulatory responses during reviews.
    • Contribute to data review, interpretation, and the publication of clinical study results.
    • Represent clinical development at Health Authorities and integrate their advice into development strategy.
    • Establish interactions with external scientific and clinical communities, integrating relevant insights into internal programs.
    • Lead the advancement of assets from discovery to clinical development, utilizing innovative approaches in translational medicine.
    • Maintain deep scientific, technical, and clinical knowledge in dermatology.

    Basic Qualifications:

    • Medical Doctor (MD), board-certified or equivalent in internal medicine or dermatology.
    • Medical education completed at a school recognized by the Liaison Committee on Medical Education (LCME) or equivalent.
    • Over 5 years of relevant clinical, scientific, or industry experience in immunology and dermatology.
    • Strong scientific background in clinical research, pharmaceutical development, or experimental medicine.
    • Knowledge of drug development processes preferred.
    • Excellent communication, problem-solving, conflict-resolution, and decision-making skills.
    • Fluent in English (both written and verbal).

    Why Choose Us?

    • Bring the miracles of science to life alongside a supportive, future-focused team.
    • Discover endless opportunities to grow your talent and career, whether through promotion or lateral moves, both domestically and internationally.
    • Enjoy a thoughtful, comprehensive rewards package that recognizes your contributions and amplifies your impact.
    • Take care of yourself and your family with a range of health and wellbeing benefits, including high-quality healthcare, wellness programs, and at least 14 weeks of gender-neutral parental leave.

    Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, national origin, age, ancestry, nationality, marital status, sex, gender identity, affectional or sexual orientation, disability, veteran status, or any other characteristic protected by law.

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