Assistant Vice President, Quantitative Clinical Pharmacology
Location
United States
Posted
58 days ago
Salary
$175K - $215K / year
Seniority
Mid Level
No structured requirement data.
Job Description
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
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