Senior Director, Clinical Pharmacology and ...

Position Summary We are looking to bring on a Senior Director of Clinical Pharmacology (CP) and Pharmacometrics to serve as the CP lead on our clinical program. Reporting to the Head of Translational Research, you will be responsible for providing strategic leadership and execution of clinical pharmacology plans. As an independent contributor you will provide scientific expertise and support all aspects of clinical pharmacology across the clinical development program. Title commensurate with experience. Key Responsibilities: Responsible for developing and executing clinical pharmacology strategies supporting multiple Phase 1 to registrational clinical studies. Provide scientific expertise to conduct pharmacokinetic/pharmacodynamic modeling, model-informed drug development including dosing regimen selection and optimization, population PK analysis, exposure-response analysis and immunogenicity assessments in pivotal clinical studies. Lead clinical pharmacology efforts to support clinical study design, study protocol preparation, analysis plans and reporting. Represent clinical pharmacology function and partner with colleagues across different functions including clinical development, clinical operations, regulatory, biometrics and translational sciences. Present and summarize clinical pharmacology strategies and outcomes to internal and external stakeholders (e.g. clinical study teams, executive team, regulatory agencies). Managing external partners including consultants and CROs while maintaining functional team budget. Qualifications PhD or PharmD in relevant discipline with 12+ years of industry experience. Strong background with advanced understanding of PK-PD analysis, quantitative modeling and simulation, PK and posology is required. Experience working on late-stage programs with multiple Phase 2 and 3 pivotal studies is a must. Excellent knowledge of relevant regulatory and ICH guidelines with experience preparing regulatory submission documents (IBs, CTDs, IND, BLA) and agency interactions. Strong communication and presentation skills with ability to communicate strategy and results to cross functional stakeholders including executive team. A broad scientific understanding of drug development process with ability to work and collaborate within a cross functions team. Experience working on late-stage clinical development of antibody-based therapeutics is preferable and hands on modeling expertise is a plus. About Upstream Bio: Upstream Bio is a public company based in Waltham, MA. We are developing verekitug, the only known antagonist currently in development that targets the receptor for Thymic Stromal Lymphopoietin (TSLP). We have advanced this highly potent monoclonal antibody into separate Phase 2 trials for the treatment of severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and plan to initiate development in chronic obstructive pulmonary disease (COPD). Our experienced team is committed to maximizing verekitugs unique attributes to address the substantial unmet needs for patients underserved by todays standard of care. Learn more about us at upstreambio.com.

Created: 2025-03-11