What are the responsibilities and job description for the Senior Director, Clinical Pharmacology and Pharmacometrics position at Upstream Bio?
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
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.
