Lead, Toxicologist

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.

Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable. Our mission would not be possible without each individual perspective within our team. It's a culture that uses unconventional thinking for unsolved problems.

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.

THE ROLE

The Lead, Toxicologist will support the design of and monitor the execution of non-clinical safety programs to aid in the development of drug candidates from discovery to market authorization. The candidate will be highly motivated and contribute to a portfolio of projects in partnership with cross-functional R&D teams to support non-clinical safety evaluations and, in turn, the translation of new therapeutics candidates.

The Lead, Toxicologist will also:

• Provide subject matter expertise within Amylyx, supporting decision-making and strategy with regards to non-clinical safety and regulatory interactions.
• Work with the Pharmacology team to design and execute non-clinical pharmacology studies.
• Advise the Preclinical Research team, providing important viewpoints in cross-functional meetings advancing therapeutic candidates.
• Help diligence external assets for potential in-licensing opportunities in partnership with the Business Development team.

RESPONSIBILITIES

• Serve on interdisciplinary project teams with focus ranging from early-stage pre-clinical through regulatory submission and post-marketing support.
• Work closely with R&D, Program Management, CMC, Regulatory Affairs, Patient Safety and Pharmacovigilance, and others to support the planning and execution of non-clinical safety studies at appropriate stages to facilitate the progression of novel therapies through development without delay.
• Offer input regarding the selection of toxicology firms, CROs, and other external collaborators.
• Deliver updates to project teams and/or senior management, including implications for overall program goals and strategy.
• Concisely summarize safety study findings as part of the writing of regulatory documents, including (but not limited to) briefing books, investigational new drug (IND) applications, Investigator Brochures (IBs), New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs).
• Act as the company toxicology representative at and address non-clinical safety questions during interactions with regulatory authorities.

REQUIREMENTS

• PhD or equivalent degree from an accredited institution in Toxicology, Pharmacology, or a related science, with 5+ years related experience; Master’s degree with 5+ years of experience; Bachelor's degree with 8+ years of experience.
• DABT certification is desirable.
• Broad knowledge in field of toxicology, with practical knowledge of pharmaceutical toxicology including:
• Approaches to discovery toxicology
• Relevant regulatory guidelines and preparation of submission documentation.
• Experience with NDA, BLA, MAA submissions is desirable.
• Experience collaborating with, monitoring, and auditing CROs prior to and during sponsored studies
• Ability to work and problem-solve effectively in a fast-paced team environment.
• Ability to communicate effectively both orally and in writing in an interdisciplinary environment.
• Can travel domestically up to 20-25%

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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.