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 and due diligence of in-licensing respiratory molecules, and presentations at advisory boards and global respiratory meetings.Job Responsibilities :Lead, manage, and mentor Clinical Sciences respiratory projects to ensure timely delivery of all milestones. Responsibilities may include but are not limited to:Contributing to and reviewing key study documents such as protocols, informed consents, amendments, eCRFs, SAP, MMP, SMP, and TLFs.Reviewing CRO medical monitoring capabilities during study start-up and RFP processes, including CVs, MMP, and investigator/site lists for vendor selection.Providing guidance on subject eligibility, deviations, and other medical, safety, or protocol-related questions to CRO medical monitors, site investigators, and study teams.Reviewing blinded efficacy and safety data, listings, tables, deviations, and supporting review of blinded SAE or SUSAR documents, addressing or escalating data impacting subject safety or study integrity.Attending internal or joint CRO-sponsor medical monitoring safety meetings and reviewing minutes.Reviewing blinded medical coding for AEs, SAEs, medications, and medical history; participating in BDRM prior to database lock and interpreting efficacy and safety after unblinding.Supporting business development for respiratory programs and portfolio, including medical affairs in BD and ROW development, new initiatives, and lifecycle management programs.Building and maintaining collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, legal, etc.). Participating in advisory boards, respiratory forums, and meetings. Engaging with regulators on clinical development pathways for faster approvals.Developing projects and evaluating new business opportunities or internal target drug candidates to expand the respiratory, allergy, and inflammation pipeline, driving strategy and delivery from clinical candidate evaluation to registration.Knowledge and Education :Educational Qualifications :MD / MSMD in Internal and Pulmonary / Critical Care MedicineExperience :Minimum 18 years of experience as a practicing pulmonary clinical professional.At least 5 years of experience in the pharmaceutical industry or clinical projects involving clinical development and regulatory interactions.Knowledge and Skills (Functional / Technical) :Drug DevelopmentScientific advocacy with policymakers / regulatorsBehavioural Attributes :The incumbent should excel in decision-making and influencing teams, with strong interpersonal skills.
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