Director, Pharmacometrics (Pop PK and PK/PD)

Job Responsibilities

• Independently develop and evaluate complex models and simulations
• Lead, manage, and collaborate effectively with cross-functional project teams to successfully support client requests
• Build partnerships with clients; provide strategic input and advice
• Provide strategic direction regarding the integration of modeling and simulation results and findings
• Assist in teaching workshops and providing training
• Mentor junior level scientists; may supervise assigned scientists
• Promote software and consulting service offerings; may assist in developing proposals and work scopes
• Serve as main point of contact for assigned clients and projects
• Consult with clients on study design through development and evaluation of models
• Provide valuable insight into the optimal use of modeling and simulation in drug development programs
• Clearly communicate and present modeling and simulation results to clients
• Use state-of-the-art software to develop, evaluate and apply PK, PK/PD and exposure-response models
• Formulate pharmacometric data analysis plans and data requirement documents, ensuring appropriateness of methods for data handling and analysis and compliance with current global regulatory guidance
• Perform model-based simulations to address critical development questions
• Write pharmacometric reports and regulatory documents
• Utilize internal resources to meet project timelines and budgets
• Share scientific knowledge and skills with other staff members
• Other duties as assigned

Qualifications

• 10+ years of population PK and PK/PD modeling experience preferred
• Proficiency in Monolix, NONMEM, and R
• Professional experience in application of Pharmacometrics to Clinical Pharmacology
• Proficient at developing and delivering presentations
• Highly self-motivated and willing to take on challenges
• Possess excellent critical-thinking, problem-solving, and interpersonal skills
• Strong verbal and written communication
• Some travel required for meetings, trainings, and conferences

Education