Associate Director, Quantitative Clinical Pharmacology

• 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 with the support of colleagues
• Participate in regulatory interactions with health authorities 
• 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 for 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 for reports and documents
• 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
• 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
• Provide mentoring and feedback to junior scientists 
• Engage in cross-divisional discussions of scientific strategy
• Serve as an expert resource for the Business Development Team
• 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 

• 6+ years of applied clinical pharmacology experience preferred
• 4+ years of leading projects, programs, and scientists 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
• Some travel required for meetings, conferences and events

• PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field
• Advanced clinical pharmacology related training preferred 

Come join the happiest employees in the industry by visiting www.simulations-plus.com/career-center and apply today!