Director / Sr Director - Clinical Development (Pulmonology)

Director / Sr Director - Clinical Development (Pulmonology) 1 week ago Be among the first 25 applicants Direct message the job poster from Glenmark Pharmaceuticals 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. Responsibilities include discussions with global regulators on respiratory clinical development pathways, 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. 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 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 SAE or SUSAR documents, addressing any data impacting safety or study integrity. Attend internal or joint CRO-sponsor 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, including new and lifecycle management programs. Collaborate with internal stakeholders across departments and participate in ad boards, forums, and regulatory discussions to facilitate clinical development pathways and approvals. 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 MD 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 projects in drug development, including regulatory interactions. Knowledge and Skills (Functional / Technical) : Drug Development Scientific advocacy with policymakers / regulators Behavioral Attributes : Strong decision-making and influencing skills. Good interpersonal skills. Seniority level Mid-Senior level Employment type Full-time Job function Research Pharmaceutical Manufacturing and Research Services J-18808-Ljbffr J-18808-Ljbffr

Location: Italia, IT

Posted Date: 8/16/2025