Senior Director, Bioanalytical LCMS

Amylyx Pharmaceuticals • Cambridge, MA

5d • Remote

About The Position

Amylyx is seeking an experienced, independently motivated senior scientific leader and subject matter expert to lead bioanalytical strategy, primarily focused on LC-MS/MS assays. The role spans discovery, preclinical, and clinical programs and oversees the design, development, qualification, validation, and implementation of assays supporting small molecules, peptides, and oligonucleotides in a highly outsourced development model. The Senior Director partners with scientific, clinical, statistical, regulatory, and program colleagues, as well as external vendors, to ensure that bioanalytical strategy and execution meet scientific, regulatory, quality, and program needs. The role serves as the bioanalytical functional lead on cross-functional program teams and contributes to vendor strategy, regulatory activities, and assessment of external opportunities.

Amylyx supports remote work within the United States, but cannot currently consider applicants residing in Alaska or Hawaii and may be unable to hire in certain other states due to health insurance and state tax considerations. The employee must be able to work remotely in a setting that supports privacy, reliable internet, phone access, and video conferencing. Travel to the Cambridge, Massachusetts corporate location several times per year and attendance at other company events are expected. Travel of up to 20% is required for vendor visits, scientific collaboration, conferences, and other business needs.

The estimated pay range is $260,000–$292,000 USD. The final offer may vary based on experience, skills, qualifications, and internal equity.

Requirements

• Ph.D. in biology, chemistry, analytical chemistry, pharmaceutical sciences, or a related scientific discipline with at least 10 years of relevant scientific and technical experience; or an M.S. with at least 12 years of relevant experience in pharmaceutical, biotechnology, or CRO environments.
• Significant experience developing and leading LC-MS/MS bioanalytical programs spanning preclinical lead nomination, IND-enabling development, and clinical Phase 1–3 programs.
• Demonstrated expertise in bioanalytical method development, qualification, validation, and sample analysis for small molecules, antisense oligonucleotides, and peptides, with expert-level capability in at least two of these modalities.
• Expert knowledge of bioanalytical regulatory requirements and guidance, including ICH M10 Bioanalytical Method Validation, and ability to apply phase-appropriate regulatory rigor throughout drug development.
• Extensive experience overseeing outsourced bioanalytical work, including vendor management, technical issue resolution, study execution, data review, and documentation.
• Demonstrated experience contributing to regulatory documents and supporting health authority interactions, and ability to translate complex bioanalytical science into clear recommendations.
• Strong scientific leadership, communication, collaboration, and influencing skills, including success working across disciplines in a fast-paced biotechnology environment.
• Ability to operate independently, manage multiple programs and external partners, adapt to evolving priorities, and travel up to 20% for business needs.
• Ability to work remotely in a setting that enables privacy, reliable internet access, phone use, and video conferencing.

Nice To Haves

• Experience in a biotechnology environment, particularly within a highly outsourced or virtual development model.
• Familiarity with complementary bioanalytical platforms such as RT-qPCR, ELISA, immunogenicity/ADA, or other large-molecule bioanalytical methods.
• Experience with CAPA, GxP-regulated bioanalysis, critical reagent lifecycle management, and due diligence of external assets.

Responsibilities

• Lead LC-MS/MS bioanalytical strategy across discovery, preclinical, and clinical development, ensuring approaches are scientifically rigorous, phase appropriate, and aligned with program timelines and regulatory requirements.
• Serve as the senior bioanalytical LCMS subject matter expert on cross-functional program teams, advising on bioanalytical and biomarker science, PK/PD testing, technical risks, timelines, and development decisions.
• Oversee outsourced bioanalytical assay development and execution, including method development, qualification, validation, sample analysis, data review, and documentation in accordance with applicable FDA, ICH, and quality expectations.
• Provide technical leadership in small-molecule, peptide, and oligonucleotide bioanalysis; identify assay challenges, determine root causes, implement fit-for-purpose solutions, and oversee critical reagent lifecycle and method performance.
• Lead external bioanalytical vendor strategy and oversight, including vendor selection, study planning, technical governance, troubleshooting, performance management, and escalation.
• Partner with discovery, toxicology, clinical pharmacology, biostatistics, clinical development, and regulatory colleagues to integrate bioanalytical data into study designs, development plans, program decisions, study reports, and regulatory strategies.
• Contribute bioanalytical expertise to protocols, regulatory submissions, reports, abstracts, posters, publications, health authority interactions, and senior-leadership presentations.
• Provide scientific and technical expertise when evaluating external assets and potential in-licensing opportunities, including bioanalytical strategy, data quality, development risks, and capability requirements.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree