Requirements: English
Company: Glenmark Pharmaceuticals
Region: Pavia , Lombardia
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 & 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 milestones.Review and contribute to 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, MMPs, and investigator/site lists.Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.Review blinded efficacy and safety data, listings, tables, deviations, and support review of blinded SAE or SUSAR documents, escalating issues impacting subject safety or study integrity.Attend internal or joint CRO-sponsor safety meetings and review medical meeting minutes.Review blinded medical coding for AEs, SAEs, medications, and medical history, participate in BDRM, and interpret efficacy and safety data post-unblinding.Support business development for respiratory programs and portfolio, including new and lifecycle management programs.Collaborate closely with internal stakeholders across various departments and participate in ad boards, respiratory forums, and meetings.Engage in discussions with regulators on clinical development pathways and accelerate drug approvals.Develop projects and evaluate new business opportunities or internal target drug candidates for pipeline expansion in respiratory, allergy, and inflammation areas.Drive strategy and delivery of respiratory programs from candidate evaluation to registration.Knowledge and Education :Educational Qualifications : MD / MS in Internal and Pulmonary / 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 (Functional / Technical) :Expertise in drug development, scientific advocacy, and regulatory processes.Behavioural Attributes :The candidate should demonstrate strong decision-making, influencing skills, and good interpersonal skills.#J-18808-Ljbffr