Senior Director, Bioanalytical LCMS — Remote Leadership

Amylyx Pharmaceuticals, Inc.; United States; À distance; USD 260 000 - 292 000; Plein temps

Résumé du poste

Amylyx Pharmaceuticals, Inc. is seeking a Senior Director, Bioanalytical LCMS to lead bioanalytical strategy across discovery through clinical development, focusing on LC-MS/MS assays for small molecules, peptides, and oligonucleotides within a highly outsourced model.

You will partner with discovery scientists, toxicologists, and regulatory teams to ensure scientific rigor, regulatory readiness, and timely program decisions, while overseeing external vendors and PK/PD data integration.

Qualifications

• Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or related field with 10+ years in pharma/biotech/CRO.
• Experience leading LC-MS/MS bioanalytical programs from preclinical to Phase 1–3.
• Expertise in bioanalytical method development, qualification, validation, and sample analysis for small molecules, antisense oligos, and peptides.
• Knowledge of bioanalytical regulatory requirements with ICH M10 and phase-appropriate rigor.

Responsabilités

• Lead LC-MS/MS bioanalytical strategy across discovery to clinical development with regulatory alignment.
• Serve as senior bioanalytical LCMS SME on cross-functional teams, guiding PK/PD testing and risk decisions.
• Oversee outsourced bioanalytical assay development, qualification, validation, and sample analysis.
• Provide leadership on multiple modalities and manage reagent lifecycle and method performance.
• Lead external vendor strategy, planning, governance, and performance management.
• Integrate bioanalytical data into study designs, development plans, and regulatory strategies.
• Contribute bioanalytical expertise to regulatory submissions and interactions.
• Evaluate external assets for in-licensing with bioanalytical considerations.

Connaissances

Scientific leadership

Communication

Cross-functional collaboration

Influencing skills

Travel readiness

Formation

Ph.D. in biology/chemistry/pharmaceutical sciences

MS with 12+ years in pharma/biotech/CRO

Outils

LC-MS/MS platforms

Bioanalytical method development tools

Description du poste

Amylyx Pharmaceuticals, Inc. is seeking a Senior Director, Bioanalytical LCMS to lead bioanalytical strategy across discovery through clinical development, focusing on LC-MS/MS assays for small molecules, peptides, and oligonucleotides within a highly outsourced model.

You will partner with discovery scientists, toxicologists, and regulatory teams to ensure scientific rigor, regulatory readiness, and timely program decisions, while overseeing external vendors and PK/PD data integration.