Senior Director, Pharmacometrics

Amylyx Pharmaceuticals•Cambridge, MA

5d•Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply. The Opportunity The Senior Director, Pharmacometrics will provide strategic and scientific leadership for pharmacometric activities supporting Amylyx’s clinical development portfolio. This leader will develop and execute model-informed drug development strategies across programs and stages of development, using quantitative approaches to inform dose selection, clinical trial design, regulatory strategy, and benefit-risk assessment. Serving as a key scientific partner to Clinical Pharmacology, Clinical Development, Biostatistics, Regulatory Affairs, Translational Medicine, and other cross-functional teams, this individual will translate complex quantitative analyses into clear, actionable recommendations for program teams and senior leadership. The role requires both strategic leadership and hands-on technical depth as programs advance toward regulatory submissions and commercialization.

Requirements

PhD, PharmD, MD, or equivalent advanced degree in Pharmacometrics, Clinical Pharmacology, Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering, Statistics, or a related quantitative discipline.
Typically 12–15+ years of relevant biotechnology or pharmaceutical industry experience, including substantial experience in pharmacometrics and model-informed drug development.
Demonstrated expertise in population PK (PopPK), PK/PD, exposure-response, modeling and simulation, and quantitative clinical pharmacology across multiple phases of clinical development.
Experience developing quantitative strategies, independently executing or overseeing complex analyses, critically evaluating results, and translating findings into clear development recommendations.
Demonstrated experience supporting regulatory submissions and preparing materials for, or interacting with, the FDA or other health authorities.
Proficiency with commonly used pharmacometric modeling and simulation tools such as NONMEM, Monolix, R, Phoenix NLME, or comparable platforms.
Strong scientific communication, presentation, collaboration, and influencing skills, including the ability to explain complex quantitative concepts to technical and non-technical audiences.
Demonstrated ability to manage external consultants, CROs, and technical vendors while operating effectively in a dynamic, growing biotechnology organization.

Nice To Haves

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.

Responsibilities

Develop and lead pharmacometrics strategies across assigned clinical development programs, aligning model-informed drug development plans with clinical and regulatory objectives.
Lead population pharmacokinetic (PopPK), PK/PD, exposure-response, disease progression, and other quantitative modeling and simulation activities to inform dose and regimen selection, trial design, patient population selection, and interpretation of clinical data.
Provide quantitative input into clinical development plans, protocols, statistical analysis plans, integrated development plans, regulatory strategies, and key program decisions throughout the development lifecycle.
Support regulatory submissions and interactions, including INDs, NDAs/BLAs, briefing documents, health authority responses, and pharmacometrics or clinical pharmacology components of submission documents.
Integrate clinical pharmacology, biomarker, efficacy, safety, and other relevant data into modeling strategies that support development recommendations and benefit-risk assessment.
Partner cross-functionally with Clinical Pharmacology, Clinical Development, Biostatistics, Data Science, Clinical Operations, Regulatory Affairs, Medical Affairs, CMC, and other functions, communicating complex results clearly to multidisciplinary teams and senior leadership.
Provide scientific oversight of external pharmacometrics consultants, CROs, and vendors, including scopes of work, analysis review, deliverable assessment, and adherence to scientific, regulatory, and quality standards.
Advance functional capabilities, processes, standards, and best practices; mentor colleagues, identify emerging quantitative methodologies, and potentially build and lead internal pharmacometrics capabilities as the organization grows.