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, and clinical phase 1-3 for LCMS, ELISA, RT-qPCR, ADA, cell-based Nab, biomarker assays.
• Demonstrated previous bioanalytical method technical expertise in small molecule, anti-sense oligonucleotides, peptides, biologics and their requisite guidance documents. Expert level technical knowledge is preferred in at least 3 of the 4, with willingness and ability to quickly learn and adapt to new technologies.
• Knowledge of preclinical and clinical drug development regulations with expert-level knowledge of the M10 BMV.
• Strong knowledge and experience with application of bioanalytical assay development, qualification/validation and sample analysis as it pertains to preclinical and clinical drug development. 
• Demonstrated experience with bioanalytical method documentation to support preclinical in vivo and clinical sample analysis. Experience working in a regulated (GxP) environment preferred but not required. 
• Strong interpersonal skills as well as excellent communication and presentation abilities.
• Ability to function in a biotech team environment by effectively collaborating within and across departments.
• Previous experience contributing to regulatory documents and interacting with health authorities.
• We are seeking an applicant who thrives in a fast-paced, team-oriented environment, and who is willing to travel up to 20% for vendor site-visits per business needs.

WORK LOCATION AND CONDITIONS

• At Amylyx, we proudly support remote work opportunities within the United States. However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas.
• You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested
• You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location

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Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. Amylyx’s management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.