The Director will report to the Senior Director and will be responsible for providing pharmacometric expertise and leading projects in support of drug development programs by applying clinical pharmacology and pharmacometric methodology from pre-clinical through late-stage development and regulatory filings. The Director will be responsible for the planning and execution of relevant quantitative analyses, which may include population pharmacokinetics (popPK), exposure response (E-R), and pharmacokinetics (PK)/pharmacodynamics (PD). The Director will act as a subject matter expert in this area and work with internal cross-functional teams as well as external vendors to deliver analyses and summary documents.

Responsibilities

As part of the Consulting Services team, the Director will:

• Support high impact product development projects in all stages of drug development using mechanism and physiologically-based PK/PD modeling and simulation methodologies, including QSP modeling, physiological based pharmacokinetic (PBPK) modeling, disease progression modeling, etc.
• Demonstrate high proficiency in the development and review of pharmacometric analysis plans relevant for regulatory approval.
• Collaborate with multidisciplinary project teams to support drug development decisions.
• Serve as a point-of-contact person on project teams, work in close collaboration with related functional groups to maximize the value of mechanistic and QSP modeling.
• Guide and supervise junior scientists in the group.
• Provide scientific and strategic expertise across therapeutic areas and promote model-informed drug discovery and development strategies.
• Perform quantitative analyses including popPK and E-R analyses and assist in the interpretation of the statistical results
• Prepare formal presentations and written reports to Pumas-AI standards.
• Lead the writing of regulatory documents related to pharmacometric analyses.
• Stay abreast of literature and government guidelines as they relate to pharmacometrics.

Qualifications and Education Requirements

• PhD or equivalent degree with substantial experience in a quantitative field (e.g., pharmacometrics, pharmacokinetics, mechanistic modeling/systems pharmacology, statistics)
• 8-10 years of experience in using a quantitative approach in describing biological systems and applying quantitative tools to enable rational and efficient drug development is required.
• Strong understanding of theory, principles and statistical aspects of advanced mathematical modeling and simulation, including numerical methods, parameter estimation/optimization, and ordinary differential equations (ODEs), and how these can be applied in the development of complex models of biological pathways and systems is required.
• Proficiency in advanced PKPD modeling and simulation software (e.g., Julia, Matlab/Simbiology, Python, NONMEM, Monolix, etc.) is required.

Preferred Skills

• Experience in establishing collaborative working relationships with internal and external stakeholders.
• Excellent interpersonal skills with ability to lead, interact with, resolve conflict and drive consensus in a multi-disciplinary team environment.
• Ability to establish collaborative working relationships with internal and external stakeholders.
• Must be self-motivated, well-organized, detail-oriented and have excellent written and verbal communication skills.

About Us

Pumas-AI is a young company led by decades of experience in diverse areas of healthcare and mathematical modeling. With a focused goal on providing better solutions for patient care, be it via pharmaceutical drug development innovation or tools for point of care, Pumas-AI aims to bring value, innovation and efficiency to healthcare. We build technology that converts the power of science into real-world applications with unprecedented speed and accuracy. At the core of everything we do is our commitment to move science forward.

We are a virtual company with team members in several countries. While this means we can work remotely from anywhere, it also means we've developed a unique culture that thrives on transparency, communication, and creativity. Each of us respects the commitments we have outside of work – and the trust and flexibility to attend to them, encouraging a healthy work/life balance.

Pumas-AI is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Our culture is one that encourages, supports and celebrates our diversity and looks to bring out the best in each other.

Do the work you love and make an impact in the lives of millions. Join us!

Terms of Employment

Reports to: Senior Director

Location: Remote

Travel Required: None

Position Type: Full-Time

Please send cover letter and CV to careers@pumas.ai.