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Director, Clinical Pharmacology

Company: Certara USA, LLC
Location: Princeton
Posted on: May 12, 2024

Job Description:

Overview

About Certara

Certara accelerates medicines using proprietary biosimulation software, technology and services to transform traditional drug discovery and development. Its clients include more than 2,000 biopharmaceutical companies, academic institutions, and regulatory agencies across 62 countries

As the Director, Clinical Pharmacology, you will lead the design, execution, and management of high quality clinical pharmacology, DMPK, and pharmacometrics studies. This position plays a pivotal role in assisting our Sr. Directors as they provide strategic clinical pharmacology guidance on drug development.

Responsibilities

Supports client projects through early translational to late development for clinical pharmacology and quantitative analyses
Collaborates with internal and client teams on regulatory, clinical development, clinical, pharmacology, pharmacometric and another drug development issues
Assist Project Leaders in writing and compiling reports and other documents summarizing advice both internally and for clients
Perform non-compartmental analyses (NCA), creation of tables, figures and listings (TFL), authoring of pharmacokinetic (PK) sections in Clinical Study Report, Regulatory Modules, PK analysis plans
Conduct data exploration and preliminary PK and PK/PD modeling in support of drug development decisions
Work collaboratively with Project Leader and clients to ensure an adequate clinical pharmacology package and study design; IND/First in human enabling packages, back translation of Clinical PK/ADME data and PK-PD relationships
Exploring/contribution in insourcing and outsourcing certain aspects of pharmacometric work, including data management and routine pharmacometric analysis
Co/authoring peer-reviewed manuscripts and publications

Qualifications

PhD, or PharmD or MD degree with specialization in pharmacology or pharmacokinetics, or in a related scientific discipline
5+ years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments
Solid experience in translational and clinical pharmacology plans and preparation of regulatory submissions (e.g. INDs, NDAs, BLAs and/or significant sNDAs/sBLAs)
Experienced in design of clinical pharmacology components of clinical development plans and optimal application of pharmacometric approaches to support decision making
Understanding and/or application of a broad range of clinical pharmacology and quantitative tools including but not limited to WinNonLin, Phoenix, NONMEM, S-Plus/R and other PK/PD analysis software
Excellent written, verbal and inter-personal communications skills
Must be able to work well with a team in a multidisciplinary environment

Certara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, p regnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.

Certara is an Equal Opportunity Employer. Certara does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: Certara USA, LLC, Trenton , Director, Clinical Pharmacology, Healthcare , Princeton, New Jersey

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