Director, Bioanalytical and Translational Science

Amylyx is a clinical-stage pharmaceutical company based in Cambridge, Massachusetts, with an audacious mission to develop novel therapies for high unmet needs. We are currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve.

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – create 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 determination, we encourage you to read the opportunity below and apply.

THE OPPORTUNITY

Amylyx is seeking an experienced and independently motivated scientist to serve as a subject matter expert supporting outsourced bioanalytical strategy, operations, and vendor management. This dynamic position will lead the design, development, and implementation of bioanalytical assays (LCMS, ELISA, qPCR, immunogenicity, cell-based biomarker, in vitro biomarker, etc.) to advance the company’s drug class agnostic preclinical and clinical pipeline.

The qualified applicant will contribute to multiple drug programs, serve as a bioanalytical subject matter expert, contribute to study designs, present data and workplans in cross functional meetings, work collaboratively with nonclinical toxicologists and clinical pharmacologists, and manage/operationalize external bioanalytical vendor relationships. The role is open to on-site or hybrid work at our Cambridge, MA office or fully remote within the continental United States.

RESPONSIBILITIES

• Working in collaboration with line management, nonclinical toxicologists and clinical pharmacologists, lead bioanalytical and biomarker method selection and outsourced MD/MQ/MV/SA to support preclinical, nonclinical, and clinical trials with adherence to established program timelines, and with regulatory rigor commensurate with drug program development phase.
• Select vendors and/or work within pre-established vendor relationships to manage outsourced bioanalytical and biomarker projects. Identify, propose, and develop new solutions to bioanalytical needs.
• Oversee outsourced bioanalytical and biomarker methods, and ensure methods are developed and qualified/validated following FDA and ICH guidelines. Review and lead bioanalytical MD/MV reports and data summaries. Work in collaboration with nonclinical toxicologists, clinical pharmacologists, and biostatisticians to review sample analysis reports and data summaries.
• Serve as a bioanalytical leader and subject matter expert in cross functional preclinical and clinical drug program teams to communicate bioanalytical and biomarker science, strategy, risks and timelines.
• Drive PK, PD, and immunogenicity testing strategy to ensure vendors complete appropriate qualification or validation work to execute on bioanalytical plan(s) on time and with appropriate quality standards.
• Demonstrated technical abilities with a flexible approach and strong ability to roll-up-your sleeves to get the job done under tight timelines and changing scope.
• Participate in planning, reviewing and authoring of regulatory and clinical documents, abstracts, posters, protocols, and publications.
• Identify and resolve root causes of bioanalytical method issues to minimize study impact. Experience with CAPA is preferred. Manage critical reagent life-cycle across program timelines.
• Prepare and organize data for cross-functional presentation. Communicate strategy and results in written and oral reports to various levels of management. Communicate research efforts to executive team members, collaborators, and/or at scientific meetings.
• Provide bioanalytical subject matter expertise to diligence on external assets and potential in-licensing opportunities 
• Excellent communication and collaboration skills and ability to work with cross-functional scientists and non-scientists. Ability to convey ideas and opinions clearly, concisely, and with a smile.
• Occasional travel required for bioanalytical collaboration, conferences and vendor oversight/audit. Travel to the Cambridge, MA office at least 3 times annually.

REQUIRED QUALIFICATIONS

• Ph.D. in biology, chemistry or a related field with at least 5 years, or MS with at least 7 years, of relevant scientific and technical experience in pharma/biotech/CRO environment. At least 2 years’ experience in biotech is non-negotiable.
• Demonstrated experience developing and leading bioanalysis projects in support of preclinical lead nomination and IND-enabling,