[Hiring] Assistant Vice President, Quantitative Clinical Pharmacology @Simulations Plus

Role Description

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 including:

• 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
• Developing and evaluating models, performing simulations, and presenting results

Job Responsibilities

• Lead and collaborate with multi-disciplinary teams to implement quantitative clinical pharmacology projects/programs
• 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
• Provide guidance to clients regarding regulatory strategy and participate in regulatory interactions with health authorities
• Support project teams with advanced PBPK, population PK, PK/PD, and exposure-response modeling and simulation
• Apply advanced scientific knowledge and expertise to assigned programs and projects
• Ensure appropriateness of methods, integrity of data, and accuracy of results
• Maintain communication between the company and clients throughout project execution
• Engage with clients regarding 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
• Ensure provision of advanced literature searches for project/program-related information
• Provide sophisticated written interpretation of material and integrate research findings
• Share findings with internal and external project teams
• Prepare abstracts, presentations, and publication-ready manuscripts
• May supervise junior scientists; provide mentoring and feedback
• Engage in cross-functional discussions of scientific strategy
• Serve as a subject matter expert resource for the Business Development Team
• Integrate knowledge of PBPK, population PK, and PK/PD for drug development guidance
• Stay current with pharmacometric and clinical pharmacology literature
• Expand scientific expertise through attendance and presentation at conferences
• 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 preferred
• Strong experience presenting scientific results to professional audiences
• Extensive experience preparing, submitting, and receiving approval for publications
• Population pharmacokinetic and pharmacokinetic/pharmacodynamic modeling experience
• Non-compartmental and compartmental pharmacokinetics experience
• Mechanistic physiologically based pharmacokinetic modeling experience
• Excellent communication, presentation, and leadership skills
• Relationship-building skills with the ability to work closely with project leaders
• Strong organization skills and ability to handle multiple tasks simultaneously
• Ability to work well under 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

Benefits

• Fully remote work
• Flexible schedules
• Generous vacation policy
• Affordable health coverage
• Stock options
• Annual bonus