Requirements: English
Company: Glenmark Pharmaceuticals
Region: Milan , Lombardy
Director/ Sr Director - Clinical Development (Respiratory)Role Overview:This position is intended to head and support the clinical development of new drugs, including conception of innovative approaches to plan clinical studies and support end-to-end drug development in accordance with all applicable regulations and aligned with the company''s business objectives. Responsibilities include discussions with global regulators on respiratory clinical development pathways for facilitating drug approvals, review & due diligence of in-licensing respiratory molecules, and participation in ad boards and global respiratory meetings.Job Responsibilities:Lead, manage, and mentor Clinical Sciences respiratory projects, ensuring timely delivery of all deliverables.Contribute to and review key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Review CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists.Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO MM, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and support review of SAE or SUSAR documents, addressing or escalating any data impacting subject safety or study integrity.Attend internal or joint CRO-sponsor safety meetings and review minutes.Review blinded medical coding for AEs, SAEs, medications, and history, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs, including new and lifecycle management programs, and collaborate with internal stakeholders.Participate in ad boards, respiratory forums, and meetings, and engage with regulators on development pathways and approval processes.Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy from candidate evaluation to registration.Knowledge and Education:Educational Qualifications: MD / MS, with internal and pulmonary/critical care medicine specialization.Experience: Minimum 18 years in pulmonary clinical practice, with over 5 years in pharmaceutical clinical development and regulatory interactions.Knowledge and Skills:Drug DevelopmentScientific advocacy with policymakers/regulatorsBehavioral Attributes:Strong decision-making and influencing skills, with good interpersonal skills.Additional Details:Seniority level: DirectorEmployment type: Full-timeJob function: ResearchIndustry: Pharmaceutical Manufacturing#J-18808-Ljbffr