Position Summary

This position is a key member of the development team, executing clinical drug development activities and evaluating the clinical pharmacology of antibody therapeutics that are focused primarily on immune–inflammatory diseases. This position reports to the Clinical Pharmacology and Toxicology department head and liaises with clinical development, clinical operations, non–clinical pharmacology and toxicology, and drug discovery to execute activities for advancing the development pipeline.

Essential Functions

• Participate in the design of clinical pharmacology strategy and studies to support clinical development programs
• Contribute clinical pharmacology sections of clinical study protocols and reports and regulatory documents including Investigator Brochures, IND, and BLA/IMPDs, etc.
• Conduct hands–on non–clinical and clinical data analysis, including non–compartmental, PK/PD and modeling analyses where applicable.
• Oversees the development and validation of quantitative in vivo assays to enable PK/PD characterization of therapeutic antibodies
• Work with nonclinical colleagues to design, analyze and interpret toxicokinetic and immnunogenicity data
• Collaborate with the clinical operations, clinical development, biostatistics/data sciences, and cross–functional project teams
• Work with Clinical Operations to ensure clinical PK/ADA/Biomarker samples are well managed
• Review clinical study protocols to ensure PK, ADA and Biomarker sampling time points are consistent with study design
• Possesses excellent communication skills to work efficiently with all stakeholders

Qualifications

• PhD, PharmD or equivalent in Pharmacokinetics, Pharmacology, Bioanalytical or related field with at least 5 years of experience in Clinical Pharmacology, DMPK or related disciplines required.
• Knowledge of pharmacokinetics and pharmacodynamics (PK/PD) and DMPK principles
• Familiarity with regulatory guidelines such as ICH, GLP and GCPs
• Working knowledge of clinical pharmacology related software tools such as WinNonlin, NONMEM, SympCyp and/or R
• Knowledge of bioanalytical assays used to support PK studies
• Experience and knowledge in translational methodologies to advance molecules from preclinical to first–in–human studies
• Knowledge of quantitative pharmacology, modeling and simulation or advanced data analysis
• Excellent team skills and proven ability to work within multi–disciplinary teams to influence the overall direction of projects
• Strong ability to prioritize daily work based on changing business requirements
• Excellent ability to multi–task in a high–energy, dynamic environment
• Self–motivated, independent, and results–oriented
• Ability to work productively in a matrix environment, as a team contributor taking ownership of multiple projects

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car

This position requires working with biological and/or chemical hazards

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.

Compensation details: 00 Yearly Salary

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