Senior Director

Job Description : Senior Director – Clinical IRELAND Open to International candidates Experience: 18+ Years Qualification: PhD / MBBS We are looking for an experienced Clinical Leader with strong expertise in Generics, Formulation Dosage Forms, and Bioequivalence (BE/BA) studies to lead global clinical strategy and 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 & III studies will be an added advantage • Strong leadership and stakeholder management skills Key Responsibilities: • Drive global clinical strategies for product submissions • Lead BE and clinical studies across multiple geographies • Support 505(b)(2) product development with R&D, IP, and Portfolio teams • Collaborate with Regulatory Affairs on clinical requirements and queries • Review study protocols, clinical reports, and regulatory documentation • Work with KOLs, consultants, and Business Development teams for molecule evaluation • Present strategic clinical insights to senior leadership • Lead and mentor clinical teams while managing departmental operations

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