This is an exciting opportunity for a Clinical Pharmacology Scientist to provide clinical pharmacology and DMPK support to all clinical development programs, including the study design, protocol review, clinical study conduct, PK and PD data analyses, and reporting of the studies.  The successful candidate will be a member of cross-functional teams to develop treatments for cancer, pediatric cancer, and pediatric genetic diseases and gain global filing experience. 

• Participate in the design of clinical pharmacology strategy and studies to support clinical development programs and inform appropriate dosing decisions for patients
• Contribute to and review clinical study protocols, study analysis plans, and reports
• Conduct hands-on non-clinical and clinical data analysis, including non-compartmental analyses and PK/PD modeling. Manage population PK/PD modeling and exposure-response (efficacy and safety) analyses based on evolving data to advance clinical programs.
• Collaborate with the clinical operation, clinical development, data management, and biostatistics, and cross-functional project teams in vendor selection and clinical study execution. Oversee the proper collection, processing, and testing of PK and biomarker samples.
• Author clinical pharmacology sections of clinical study reports, present PK/PD data at cross-functional team meetings
• Present the study results externally in meeting abstracts, posters, and/or manuscripts in scientific journals.
• Author clinical pharmacology and DMPK sections of documents for regulatory submissions
• Manage external clinical pharmacology vendors

• A Ph.D. or PharmD with 1+ years, an MS with 4+ years of experience in clinical pharmacology in the biotech/pharmaceutical industry; Equivalent experience may be accepted
• Must have hands-on experience with clinical pharmacology and ADME study design, data analysis, non-compartmental and PK/PD modeling using data processing software such as Phoenix WinNonlin and R
• Familiar with quantitative approaches in drug development. Working knowledge of relevant modeling software such as NONMEM, MONOLIX, Berkeley Madonna, or SimCyp is desirable. Proficiency in statistical and graphing software such as SigmaPlot, Prism, JMP, or R
• In-depth understanding of PK/PD, drug metabolism, translational pharmacology, and drug development concepts
• Ability to work effectively in a dynamic, fast-paced, collaborative, and team-oriented environment. Demonstrate critical thinking and problem-solving capabilities
• Good project management skills and the ability to manage multiple, diverse tasks and to prioritize tasks effectively is required
• Attention to details, able to proactively identify issues and propose solutions
• Excellent written and verbal communication and interpersonal skills, initiative, and commitment to excellence are required; must be able to independently create high-quality written reports and summary documents for use in regulatory submissions
• Knowledge in regulatory guidance, requirements, and expectations in the US and internationally, and ICH and GCP is a plus