Senior Director, Pharmacometrics — Strategic Leader

Amylyx Pharmaceuticals, Inc.; Cambridge (MA); Remoto; USD 268.000 - 291.000; Tempo pieno

Descrizione del lavoro

Amylyx Pharmaceuticals, Inc. in the US seeks a Senior Director, Pharmacometrics to lead model-informed drug development across programs, driving dose selection and regulatory strategy. The role combines strategic leadership with hands-on quantitative modeling and cross-functional collaboration to accelerate clinical plans.

Remote-friendly within the United States; periodic travel to Cambridge, MA is expected as programs advance toward regulatory submissions and commercialization.

Competenze

• PhD, PharmD, MD, or equivalent in a quantitative field.
• 12–15+ years in biotech/pharma with pharmacometrics exposure.
• Expertise in PopPK, PK/PD, exposure–response, modeling and simulation.
• Experience translating analyses into development recommendations.
• Regulatory submissions support and FDA interactions.
• Proficiency with commonly used pharmacometric tools (NONMEM, Monolix, R, Phoenix NLME).
• Strong scientific communication and cross-functional influence.
• Experience managing external consultants/CROs and vendors.

Mansioni

• Develop and lead pharmacometrics strategies across assigned clinical development programs.
• Lead population PK/PK–PD, exposure–response, and other quantitative modeling activities to inform dose and trial design.
• Provide input into clinical development plans, protocols, and regulatory strategies.
• Support regulatory submissions and health authority interactions.
• Integrate clinical and biomarker data into modeling for benefit‑risk assessment.
• Collaborate cross‑functionally with Clinical Pharmacology, Biostatistics, Regulatory, Medical Affairs, and others.
• Provide scientific oversight of external pharmacometrics consultants, CROs, and vendors.
• Advance capabilities, processes, and mentor colleagues.

Conoscenze

Pharmacometrics

PK/PD modeling

PopPK

Regulatory strategy

FDA interactions

NONMEM

Monolix

R

Phoenix NLME

Scientific communication

Formazione

PhD or MD or PharmD (Pharmacometrics)

Strumenti

NONMEM

Monolix

R

Phoenix NLME

Descrizione del lavoro

Amylyx Pharmaceuticals, Inc. in the US seeks a Senior Director, Pharmacometrics to lead model-informed drug development across programs, driving dose selection and regulatory strategy. The role combines strategic leadership with hands-on quantitative modeling and cross-functional collaboration to accelerate clinical plans.

Remote-friendly within the United States; periodic travel to Cambridge, MA is expected as programs advance toward regulatory submissions and commercialization.