Senior Director

Job Description : Senior Director – Clinical IRELAND Experience: 18+ Years Qualification: PhD. / MBBS Open to International candidates We are looking for an experienced Clinical Leader with strong expertise in the Generics business, formulation dosage forms, and Bioequivalence (BE/BA) studies to lead global clinical strategy and project execution. Key Requirements: • Strong experience in Generics and Formulation Dosage Forms • Mandatory exposure to BE/BA studies • Expertise in global clinical development and regulatory strategy • Exposure to Phase II & Phase III studies will be an added advantage • Strong leadership and stakeholder management capabilities Key Responsibilities: • Develop and drive global clinical strategies for product submissions • Lead patient-based BE and clinical studies across multiple geographies • Provide expertise in non-clinical studies, immunogenicity studies, and modelling/simulations • Support new product ideation for 505(b)(2) molecules along with R&D, IP, and Portfolio teams • Review in-licensing dossiers and support molecule selection with Business Development teams • Work closely with Regulatory Affairs to address clinical requirements and regulatory queries • Review study protocols, clinical expert reports, and registration documentation • Collaborate with KOLs and consultants for product development and regulatory support • Present clinical insights and strategic recommendations to senior management • Lead and mentor clinical teams while managing departmental operations and budgets

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