Requirements: English
Company: Glenmark Pharmaceuticals
Region: Brescia , Lombardy
Pls note : Incumbent can be based anywhere in Europe or the US.Role Overview :This position is intended to head and support the clinical development of new drugs, focusing on 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. The role involves discussions with global regulators on respiratory clinical development pathways to facilitate drug approvals, review and 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 to ensure timely delivery of all milestones.Review key study-related documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Assess CRO medical monitoring capabilities during study startup and RFP processes, including review of CVs, MMP, and investigator/site lists.Guide on subject eligibility, deviations, and 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 any data impacting subject safety or study integrity.Participate in medical monitoring safety meetings and review minutes.Review blinded medical coding for AEs, SAEs, medications, and medical history, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development.Collaborate with internal stakeholders across departments.Participate in ad boards, respiratory forums, and meetings, and discuss clinical development pathways with regulators.Evaluate new business opportunities and internal drug candidates for pipeline expansion.Drive the strategy and delivery of respiratory programs from candidate evaluation to registration.Knowledge and Education :Educational Qualifications: MD / MS, with specialization in Internal Medicine, Pulmonary, or Critical Care Medicine.Experience :Minimum 18 years as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical project management, including regulatory interactions.Knowledge and Skills :Expertise in drug development, scientific advocacy, and regulatory engagement.Behavioral Attributes :Strong decision-making and influencing skills, with good interpersonal abilities.#J-18808-Ljbffr