American Society for Clinical Pharmacology and Therapeutics
ASSOCIATE VICE PRESIDENT, QUANTITATIVE CLINICAL PHARMACOLOGY
American Society for Clinical Pharmacology and Therapeutics, Germantown, Ohio, United States
The Associate 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.
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-divisional 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
15+ years of applied clinical pharmacology experience
10+ 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
Some travel required
Education
PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field
Advanced clinical pharmacology related training preferred
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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-divisional 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
15+ years of applied clinical pharmacology experience
10+ 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
Some travel required
Education
PharmD, PhD, or masters in pharmacokinetics, clinical pharmacology, or related field
Advanced clinical pharmacology related training preferred
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