We are seeking candidates to enhance and further our clinical pharmacology services globally through high-quality work, strategic client interactions, publications and presentations. They will serve as the main point-of-contact and project leads for assigned projects, effectively using internal resources to meet project timelines and budgets to client satisfaction. They will develop pharmacometrics analysis plans, and to implement appropriate methods for data handling, analysis and reporting, in compliance with current regulatory guidance and industry best practice.
Key qualities in the candidate include organizational leadership through influential, interpersonal skills, and understanding of organizational dynamics to maximize Amador’s effectiveness, and to influence the industry through participation in external-facing opportunities.
Additional key attributes include:
Highly self-motivated and willing to take on challenges
Must have the ability to think creatively and have the technical capability to address challenges
Ability to build relationships and work closely with global internal and external teams
Use translational simulations to project the human PKPD for the starting-dose selection for first-in-human studies. Perform population- and/or mechanism-based modeling to characterize the PK and PD of candidate drugs. Perform clinical trial simulations to support development decisions. Contribute to Model Informed Drug Development exercises for clients
Assist with the design, analysis, and interpretation of studies involving sparse sampling and provide guidance to optimize PK sampling and dosing strategies
Author or contribute to pharmacometrics reports and related sections of regulatory documents; participate in regulatory meetings if requested.
Present and report data in approved external meetings and publications
Maintain current knowledge of advancements in pharmacometrics and clinical pharmacology science, regulatory guidance documents, FDA rulings, internal SOPs, and internal working practices; contribute ideas to improve technologies and procedures for best pharmacometrics practices
Qualifications and Education Requirements
Master or doctorate degree in pharmaceutical sciences, statistics, chemical engineering, or related field. Experience in modeling/simulation strategies is highly desired.
Proven experience in quantitative pharmacology and strong hands-on modeling and simulation experience
Pharmacometrician (MS: 2-4 years of relevant experience; PhD: 0-2 years of experience)
Senior Pharmacometrician (MS: 4-6 years of experience; PhD: 2-5 years of experience)
Experience with population PKPD modeling software (NONMEM, R, SAS, MATLAB, Phoenix, GastroPlus, etc.)
Demonstrated ability to independently plan, organize, and analyze PK/PD data is essential.
Highly motivated individual with a strong intellectual and technical background in Pharmacometrics discipline.
Excellent problem-solving, written and oral communication skills.
At Amador we provide global-standard translational sciences and clinical pharmacology services to biopharmaceutical companies in US, EU and China. Supported by top Venture Capitalists in technology and healthcare, Amador aims to become a leading global partner for the successful development of novel and improved biotherapeutics.