Simulations Plus is a leading developer of modeling and simulation software, and a provider of consulting services. We support our pharmaceutical and biotechnology clients through drug discovery, development research, and regulatory submissions.

Leadership truly cares about maintaining a positive culture and for employee well-being. We offer fully remote work, flexible schedules, unlimited vacation along with free medical premiums, stock options, bonus potential, and more!

We are looking for a Director, Quantitative Clinical Pharmacology to lead multi-disciplinary project teams through the successful completion of client goals. This role will engage in activities ranging from consultations on study design through the development and evaluation of models, the performance of simulations, and the presentation of results.

Division: Cognigen

Department: Clinical Pharmacology

Location: This position can be 100% remote or hybrid near Buffalo, NY 

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 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
• 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 

Qualifications: 

• 10+ years of applied clinical pharmacology experience
• 8+ 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 

Education: 

• PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field
• 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!

Base Pay Range: 150k – 175k USD per year