Requirements: English
Company: Glenmark Pharmaceuticals
Region: Biella , Piedmont
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 deliverables. 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 any data impacting subject safety or study integrity. Attend internal or joint CRO-sponsor medical monitoring safety meetings and review minutes. Review blinded medical coding for AEs, SAEs, medications, and medical history, participating in BDRM and providing primary interpretation after unblinding. Support business development for respiratory programs and portfolio, including new and lifecycle management programs. Collaborate 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 faster approvals. Develop projects and evaluate new business opportunities or internal drug candidates to expand the respiratory, allergy, and inflammation pipeline. Drive the 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 of experience as a practicing pulmonary clinical professional, with over 5 years in the pharmaceutical industry or clinical development, including regulatory interactions. Knowledge and Skills: Drug development, scientific advocacy with policymakers/regulators. Behavioral Attributes: Strong decision-making and influencing skills, good interpersonal skills.#J-18808-Ljbffr