Assistant Vice President, Quantitative Clinical Pharmacology

Simulations Plus stands as a premier provider in the biopharma sector, offering advanced software and consulting services that enhance drug discovery, development, research, clinical trial operations, regulatory submissions, and commercialization.

Our comprehensive biosimulation solutions integrate artificial intelligence/machine learning, physiologically based pharmacokinetics, physiologically based biopharmaceutics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches.

We also deliver simulation-enabled performance and intelligence solutions alongside medical communications support for clinical and commercial drug development. Our cutting-edge technology is licensed and utilized by leading pharmaceutical, biotechnology, and regulatory agencies worldwide.

Leadership truly cares about maintaining a positive culture and employee well-being. We offer fully remote work, flexible schedules, and generous vacation policy along with affordable health coverage, stock options, annual bonus, and more! Check out how much our employees love working here: https://www.comparably.com/companies/simulations-plus.

The Assistant Vice President, Quantitative Clinical Pharmacology will lead multi-disciplinary project teams through the successful completion of client goals. This role will engage in activities ranging from developing MIDD-based clinical pharmacology strategies for client development programs, serving as an embedded clinical pharmacology representative for clients, supporting clinical pharmacology objectives by providing consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results.

Department: Strategic Consulting Services/Clinical Pharmacology and Pharmacometrics

Internal Grade: 17

Direct Reports: Optional

Status: Exempt

Location: Remote

Job Responsibilities:

• Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs and to provide clinical pharmacology and pharmacometric consultation to other company projects/programs
• Support clinical pharmacology-related components of clinical study protocols, study conduct, data analysis, and report writing independently and with the support of colleagues
• Provide guidance to clients regarding regulatory strategy and participate in regulatory interactions with health authorities on behalf of clients
• Support project teams by providing clinical pharmacology and pharmacometric consulting through advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation as well as noncompartmental analyses, using GastroPlus, MONOLIXSuite (PKAnalix, MONOLIX, Simulx), NONMEM, R, or other tools
• Apply advanced scientific knowledge and expertise to assigned programs and projects
• Responsible for appropriateness of methods, integrity of data used for analysis, and accuracy of results
• Ensure communication between the company and clients throughout project execution
• Regularly engage with clients regarding the strategic approach, presentation of results, regulatory implications, and messaging of findings
• Initiate and maintain positive, productive, and profitable client relationships
• Prepare final technical reports, synopses, executive summaries, and other regulatory documents, including CTD Section 2.7.2, 2.7.1, Integrated Summary of Efficacy, Integrated Summary of Safety, Briefing Books, Question-and-Response documents, and other documents as needed
• Ensure the provision of advanced literature searches for project/program-related information
• Provide sophisticated written interpretation of material and integrate research findings into project/program methodology and results
• Share findings with internal and external project teams
• Prepare abstracts, presentations, and publication-ready manuscripts
• May supervise junior scientists; provide mentoring and feedback to junior scientists
• Engage in cross-functional discussions of scientific strategy
• Serve as a subject matter expert resource for the Business Development Team; draft work scopes, strategies, and proposals; develop budgets for new projects
• Integrate knowledge of PBPK, population PK, and PK/PD to provide guidance regarding proposed approaches to addressing drug development and regulatory approval challenges
• Stay current with pharmacometric and clinical pharmacology literature and project/program-related literature
• Expand scientific expertise through attendance and presentation at international, national, and regional scientific conferences, client meetings, and government meetings
• Develop and teach at GastroPlus, MONOLIX, and other workshops and courses
• Other duties as assigned

Qualifications:

• 12+ years of applied clinical pharmacology experience
• 8+ years of leading projects, programs, and scientists preferred
• Experience as a clinical pharmacologist in a drug development organization preferred
• Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students preferred
• Strong experience presenting scientific results to professional audiences
• Extensive experience preparing, submitting, and receiving approval for publications in scientific journals
• Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling and simulation experience
• Non-compartmental and compartmental pharmacokinetics experience
• Mechanistic physiologically based pharmacokinetic modeling and simulation experience
• Excellent communication, presentation, and leadership skills
• Relationship-building skills with the ability to work closely with project leaders and team members
• Strong organization skills and ability to handle multiple tasks simultaneously
• Work well handling tight deadlines
• Great critical-thinking and problem-solving skills
• Occasional travel for meetings, trainings, and conferences

Education:

• Master’s degree in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field
• PharmD, PhD in pharmacometrics, PK/PD, pharmaceutics, pharmacology, statistics, engineering, or related field preferred
• Advanced clinical pharmacology related training preferred

Find out more about how amazing it is to work at Simulations Plus by visiting www.simulations-plus.com/career-center and apply today!