Associate Director, Quantitative Clinical Pharmacology

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and work collaboratively with multi-disciplinary teams on quantitative clinical pharmacology projects and initiatives.

• Offer clinical pharmacology and pharmacometric guidance to company projects and programs.

• Assist in the development of clinical study protocols, execution of studies, data analysis, and report preparation.

• Engage in regulatory discussions with health authorities.

• Provide consulting services utilizing PBPK, population PK, PK/PD, exposure-response modeling and simulation, and noncompartmental analyses.

• Employ tools such as GastroPlus, MONOLIXSuite, NONMEM, R, or other relevant software.

• Apply advanced scientific expertise to assigned projects and programs.

• Ensure that methods used are appropriate and that data integrity and result accuracy are maintained.

• Facilitate communication between the company and clients throughout the duration of projects.

• Involve clients in discussions regarding strategic approaches, findings, regulatory implications, and results.

• Cultivate positive, productive, and profitable relationships with clients.

• Create technical reports, summaries, executive summaries, and regulatory documentation.

• Conduct advanced literature reviews and incorporate research findings into project methodologies and outcomes.

• Share findings with both internal and external project teams.

• Prepare abstracts, presentations, and manuscripts that are ready for publication.

• Mentor and provide constructive feedback to junior scientists.

• Take part in cross-divisional scientific strategy discussions.

• Act as an expert resource for the Business Development Team.

• Keep abreast of relevant scientific literature.

• Attend and present at conferences, client meetings, and governmental meetings.

• Develop and conduct workshops and courses on GastroPlus, MONOLIX, and other related topics.

• Perform additional duties as assigned.

⛳️ Requirements

• A minimum of 6 years of practical clinical pharmacology experience is preferred.

• At least 4 years of experience in leading projects, programs, and teams of scientists is preferred.

• Prior experience supervising junior clinical pharmacologists, pharmacometricians, fellows, and students is preferred.

• Strong background in presenting scientific results to professional audiences.

• Extensive experience in preparing, submitting, and obtaining approval for publications in scientific journals.

• Experience in population pharmacokinetics and pharmacokinetic/pharmacodynamic modeling and simulation.

• Familiarity with both non-compartmental and compartmental pharmacokinetics.

• Experience in mechanistic physiologically based pharmacokinetic modeling and simulation.

• Exceptional communication, presentation, and leadership capabilities.

• Strong relationship-building skills, enabling close collaboration with project leaders and team members.

• Excellent organizational skills with the ability to manage multiple tasks concurrently.

• Capability to meet tight deadlines.

• Strong critical thinking and problem-solving abilities.

• Some travel may be necessary for meetings, conferences, and events.

• A PharmD, PhD, or Master's degree in pharmacokinetics, clinical pharmacology, or a related field is required.

• Advanced training in clinical pharmacology is preferred.

🏝️ Benefits

• Fully remote work options.

• Flexible working schedules.

• Generous vacation policy.

• Affordable health insurance coverage.

• Annual bonus opportunities.

• Support for employee well-being.

• Positive workplace culture.