Lead, Clinical Development (ALS)

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.

At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.

Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.

Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• AMX0035 is currently under review with the European Medicines Agency
• 350 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

POSITION SUMMARY

The Lead Clinical Development (ALS) will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will function as a Clinical Scientist, reporting to a Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).

RESPONSIBILITIES

• Collaborates with the clinical development team in review, analysis, and interpretation of study results.
• Provides scientific support on ongoing Phase I to III clinical trials and contributes to the planning and design of upcoming clinical studies.
• Performs monitoring and review of study data including labs, safety and efficacy data, and patient eligibility.
• Authors and/or reviews clinical trial-related documents including protocols, CRF, deviation and monitoring plans, regulatory documents, etc.
• Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs.
• Interacts with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.
• Supports business development and translational medicine activities.
• Other duties as assigned.

REQUIREMENTS

• Advanced degree (Ph.D., Pharm.D., Master’s Degree in Science/Medical-related fields).
• 2+ years of Clinical Research, Pharmaceutical, or CRO experience.
• Knowledge of Phase 1-3 drug development.
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
• Prior experience working within neurology or neurodegenerative indications.
• Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations.
• Strong, collaborative team-player.
• Excellent attention to detail and communication skills.

 

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. 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.