Senior Director, Pharmacometrics

The role

The Senior Director, Pharmacometrics provides strategic and scientific leadership for pharmacometric activities. This person will develop and execute model-informed drug development strategies to inform dose selection, clinical trial design, and regulatory strategy.

What you will do

• Develop and lead pharmacometrics strategies across clinical development programs
• Lead population PK, PK/PD, exposure-response, and other quantitative modeling activities
• Provide quantitative input into clinical development plans, protocols, and regulatory strategies
• Support regulatory submissions and interactions including INDs and NDAs/BLAs
• Integrate clinical pharmacology, biomarker, efficacy, and safety data into modeling strategies
• Partner cross-functionally with Clinical Pharmacology, Clinical Development, and other teams
• Provide scientific oversight of external pharmacometrics consultants, CROs, and vendors
• Advance functional capabilities, processes, standards, and best practices
• Mentor colleagues and potentially build and lead internal pharmacometrics capabilities

Required qualifications

• PhD, PharmD, MD, or equivalent advanced degree in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Statistics, or a related quantitative disci
• 12–15+ years of relevant biotechnology or pharmaceutical industry experience
• Substantial experience in pharmacometrics and model-informed drug development
• Expertise in population PK (PopPK), PK/PD, exposure-response, modeling and simulation, and quantitative clinical pharmacology
• Experience developing quantitative strategies and translating findings into development recommendations
• Experience supporting regulatory submissions and interacting with the FDA or other health authorities
• Proficiency with pharmacometric modeling and simulation tools such as NONMEM, Monolix, R, or Phoenix NLME
• Strong scientific communication, presentation, collaboration, and influencing skills
• Ability to manage external consultants, CROs, and technical vendors
• Access to a work setting with privacy, reliable internet, phone, and video conferencing ability

Nice to have

• Experience supporting late-stage clinical development and regulatory submissions
• Knowledge of evolving regulatory expectations and guidance related to population pharmacokinetics, exposure-response analyses, and model-informed drug development
• Experience building pharmacometrics capabilities, mentoring technical colleagues, or leading a pharmacometrics function

Benefits

• Base salary
• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska, Arizona, Hawaii, Michigan and Tennessee

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The company has a mission to treat diseases with high unmet needs through rigorous science.