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At Insmed, every moment and every patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you'll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person's contributions to meaningful progress. That commitment has earned us recognition as Science magazine's No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK.For patients, for each other, and for the future of science, we're in. Are you?About the Role:We're looking for a Director of Clinical Biomarkers on the Clinical Development team to help us expand what's possible for patients with serious diseases. Reporting to the Executive Director, Translational Bioanalytical Science , you'll lead identification and validation of clinical biomarkers to support decision-making across the clinical development lifecycle for all therapeutic areas at Insmed. We are seeking a highly motivated partner across functions to design and deliver biomarker strategies that connect drug mechanism, patient biology, and clinical endpoints across immune-mediated and inflammatory diseases. This translational role within the Clinical Development organization works closely with colleagues in other functional areas including multiple Research groups. This is a hybrid role, expected to be in the office weekly.What You'll Do: In this role, you'll have the opportunity to drive the scientific strategy and implementation of biomarker plans to support clinical development programs. This role will provide leadership across external CROs and specialty laboratories and will conduct both technical and strategic evaluations of emerging and innovative biomarker platforms to advance Insmed's development pipeline.The role requires a leader who leverages deep scientific expertise, sound decision-making, and strong collaboration skills to drive alignment across teams on biomarker hypotheses, strategies, and readouts that inform key development decisions within a dynamic, matrixed environment. You'll also: * Collaborate with multiple internal and external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety, contract research organizations etc.) to build and execute the biomarker strategy specific to clinical development programs. * Identify, develop, and validate translational and clinical biomarker assays across pharmacokinetics, immunogenicity (ADA and NAb assays), pharmacodynamics, and predictive endpoints. * Lead method development of clinical biomarker assays for Global Clinical Development both in-house and at external CROs across all modalities. * Participate in preclinical study design and documentation as they relate to Translational activities needed in advance of planned clinical development programs. * Perform in-depth scientific literature review to help address critical questions relating to target biology, clinical relevance, and associated assays. * Participate in clinical study design and documentation (lab manual, protocol, SAP). * Provide input into applicable sections of clinical documents, consolidating feedback from SME, including study protocols, regulatory documents and communications (IND, NDA, BLA, PMA, etc.), Briefing Book (BB), Investigatory Brochure(IB), Clinical Study Reports (CSR), study start up (e.g. ICF, data transfer agreements) and data base lock activities (e.g. sample reconciliation, data review/QC and transfer), etc. * Providing consultation and technical support for preclinical and clinical Immunogenicity strategy discussions within Global BA and providing data interpretation consistent with current industry and health authority expectations. * Participate in clinical study design and documentation (lab manual, protocol, SAP. * Manage and monitor externally contracted laboratories for regulated preclinical and clinical work, ensuring quality data generation and reporting.Who You Are:You have a PhD in Analytical, Pharmacokinetics, Pharmacology, Pharmaceutics or another relevant field or M.D. or PharmD with equivalent experience, along with 10+ years of experience in the pharmaceutical industry.You are or you also have: * Significant proven expertise in rare and respiratory diseases, including a deep understanding of: * Biomarker identification and strategic implementation in clinical studies * Therapeutic mTo view the full job description, click hereApply here: https://www.aplitrak.com/?adid=YmJnZW5lcmljLjEzMjI1LjEwNDEyQGluc21lZGNvbXAuYXBsaXRyYWsuY29t