Director / Senior Director Clinical Pharmacology

NextCure is a growing clinical-stage biopharmaceutical company located in Beltsville focused on discovering and developing first-in-class immunomedicines for the treatment of cancer and other immune related diseases.

We are seeking a scientifically minded Clinical Pharmacologist to join our Translational Research team and help lead clinical pharmacology functions providing scientific and technical hands-on support to project teams from candidate selection through clinical development and approval. This person will work with immunologists, tumor biologists, and the bioanalytical team to evaluate pharmacokinetic and pharmacodynamic relationships of our clinical and preclinical candidates along with immunogenicity and toxicology. NextCure is committed to professional development in the context of learning, managing, and developing its employees. We create a unique environment for our employees, providing exposure to various facets of our operations cultivating career growth and development.

Responsibilities

• Manage data analysis in support of clinical and preclinical studies
• Participate in the evaluation of exposure-efficacy and exposure-toxicity relationship
• Manage and conduct experiments/studies internally and at external laboratories to support clinical development of preclinical candidates
• Determine therapeutic window by integrating data from in vitro activity, preclinical PK/PD, and tox
• Assist in preparation of regulatory documents including PK clinical study reports, IND filings, and annual reports
• Engage cross-functional drug development teams to enable preclinical candidate selection and clinical development
• Support bioanalytical team in assay development, validation, and execution including reviewing of study protocols and reports
• Engage in special, value-added projects

Required education and experience

• PhD and/or MD with experience in drug development.
• A minimum of 5 years of relevant industry experience, preferably with biologics
• Expertise in PK/PD modeling using advanced software package such as ADAPT and WinNonLin is highly preferred

Qualifications

• Ability to drive, manage, execute, and deliver results for complex multi-functional projects
• Working knowledge of current practices in areas of clinical pharmacology, pharmacokinetics, bioanalysis, biopharmaceutics, and regulatory affairs
• Experience working with external CROs and managing timely delivery of clear, accurate, and well written study findings
• Experienced and skilled working with matrix teams

NextCure is an Equal Opportunity Employer and offers a competitive salary and benefits package in a scientifically engaged teamwork environment.