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Simulations Plus, Inc. · 3 months ago

Director, Quantitative Clinical Pharmacology

United States

Full-time

Remote

Director/Executive

$150K/yr - $200K/yr

10+ years exp

Simulations Plus is a leading provider of biosimulation and medical communications solutions to the biopharma industry. The Director, Quantitative Clinical Pharmacology will lead multi-disciplinary project teams, engaging in consultations on study design, model development, and result presentations to achieve client goals.

ConsultingImpact InvestingService IndustrySoftware

Growth Opportunities

H1B Sponsor Likely

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

Qualification

Clinical pharmacology experiencePopulation PK/PD modelingMechanistic PBPK modelingScientific communicationLeadership experienceProject managementRelationship-building skillsCritical-thinking skillsProblem-solving skillsOrganizational skills

Required

10+ years of applied clinical pharmacology experience

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

Preferred

8+ years of leading projects, programs, and scientists

Previous supervision of junior clinical pharmacologists and pharmacometricians, fellows, and students

Strong experience presenting scientific results to professional audiences

Extensive experience preparing, submitting, and receiving approval for publications in scientific journals

Advanced clinical pharmacology related training

Benefits

Fully remote work

Flexible schedules

Generous vacation policy

Affordable health coverage

Stock options

Annual bonuses

Company

Simulations Plus, Inc.

Simulations Plus is a leading provider of modeling and simulation software and consulting services supporting drug discovery, development research, and regulatory submissions.

Founded in 1996

Research Triangle Park, NC, US

201-500 employees

https://www.simulations-plus.com

H1B Sponsorship

Simulations Plus, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (4)

2024 (4)

2023 (5)

2022 (4)

2021 (3)

2020 (4)