Director / Senior Director Clinical Pharmacology
- NextCure, Inc.
- Beltsville, MD
- Start date
- Mar 11, 2023
- Clinical, Clinical Research, Science/R&D, Pharmacology
- Required Education
- Position Type
- Full time
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.
- 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
- 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.
NextCure is a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases by restoring normal immune function. We view the immune system holistically and, rather than target one specific immune cell type, we focus on understanding biological pathways, the interactions of cells and the role each interaction plays in an immune response. Through our proprietary Functional, Integrated, NextCure Discovery in Immuno-Oncology, or FIND-IO, platform, we study various immune cells to discover and understand targets and structural components of immune cells and their functional impact in order to develop immunomedicines. We are focused on patients who do not respond to current therapies, patients whose cancer progresses despite treatment and patients with cancer types not adequately addressed by available therapies.
Cancer is a complex disease where cells in the tumor microenvironment promote tumor progression, immune evasion and suppression of anti-tumor immune responses. While therapies targeting inhibitory or immune checkpoint molecules have shown important success in many cancers, not all patients benefit from these therapies (non-responders), and many develop resistance after initial treatment. NextCure is identifying novel tumor-specific interactions and mechanisms of immune regulation to generate a sustainable product pipeline to address these patients in need.
NextCure brings significant experience and innovation in cancer immunology. The company’s FIND-IOTM technology provides a large repertoire of function-based screens and imparts a unique understanding of cell surface molecular interactions between immune and diseased cells. We are using this important knowledge to rapidly develop and advance novel biologics that impact suppressive myeloid cell populations, T cell subsets, and other cell populations within the tumor microenvironment to restore anti-tumor activity and improve clinical response rates and outcomes for patients.
Stock Symbol: NXTC
9000 Virginia Manor Rd. Suite 200
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