Requirements: English
Company: Glenmark Pharmaceuticals
Region: Belluno , Veneto
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 aligning 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 to ensure timely delivery of all deliverables.Contribute to and review key study-related 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 for vendor selection.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 blinded SAE or SUSAR documents, addressing or escalating data impacting 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 interpreting efficacy and safety post-unblinding.Support business development for respiratory programs, portfolio, and medical affairs in BD and ROW development, including new and lifecycle management programs.Build and maintain collaboration with internal stakeholders across departments.Participate in ad boards, respiratory forums, and meetings, and engage with regulators on clinical development pathways for faster approvals.Develop projects and evaluate new business opportunities or internal Target Drug Candidates to expand the respiratory, allergy, and inflammation pipeline.Drive strategy and delivery of respiratory programs from candidate evaluation to registration.Knowledge and Education :Educational Qualifications : MD / MS, with specialization 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 project development, including regulatory interactions.Knowledge and Skills (Functional / Technical) :Expertise in drug development, scientific advocacy with policymakers/regulators.Behavioral Attributes :The candidate should demonstrate sound decision-making, influencing skills, and good interpersonal skills.#J-18808-Ljbffr