Associate Director, Pharmacometrics (Remote - Part Time)

Job Description

Job Description

Contact : Neisha Camacho / Terra Parsons -

No 3rd party candidates

Position Summary

The Associate Director, Pharmacometrics will serve as a strategic leader, accountable for driving model-informed drug development across programs. This role will oversee and conduct pharmacometric analyses — including population PK / PD, exposure–response, PBPK, and clinical trial simulations — to inform study design, dose selection, and regulatory interactions. The Associate Director will partner with senior leaders across statistics, clinical, regulatory, and research functions, lead collaborations with external vendors, and mentor internal team members to expand pharmacometric capabilities.

Primary Responsibilities

• Provide strategic leadership for pharmacometric approaches across multiple programs, ensuring alignment with development objectives and regulatory expectations.
• Lead pharmacometric analyses (population PK / PD, exposure–response, PBPK) and collaborate with statistics on clinical trial simulations to inform clinical study design, dose selection, and regulatory submissions.
• Serve as the primary pharmacometric representative in cross-functional development teams and regulatory interactions.
• Critically evaluate data quality and appropriateness for pharmacometric analyses, ensuring robust and transparent model development.
• Author and review pharmacometric sections of regulatory documents, including clinical study protocols, study reports, briefing books, and IND / NDA / BLA submissions.
• Guide development and execution of Modeling & Simulation (M&S) strategies, including disease progression models and clinical trial simulations, partnering with external vendors as appropriate.
• Mentor and train junior colleagues, fostering expertise in quantitative pharmacology tools and approaches.
• Communicate outcomes of pharmacometric analyses to diverse stakeholders, translating results into actionable insights for clinical and regulatory decision-making.
• Contribute to thought leadership through publications, conference presentations, and participation in scientific consortia.

Desired Experiences

Qualifications and Key Success Factors