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Director, Nonclinical and Translational Science

Amylyx Pharmaceuticals · Cambridge, MA · $216k–$243k

Posted by Amylyx Pharmaceuticals on their careers site · View the original posting

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The posting, as Amylyx Pharmaceuticals wrote it

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).

Our mission is powered by our people. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating 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 are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.

The Opportunity

The Director, Nonclinical and Translational Science will provide strategic and scientific leadership for nonclinical and translational programs across the development portfolio. This individual will lead programs from candidate nomination through IND-enabling development, regulatory submission, and translation into first-in-human clinical trials and beyond. Working closely with cross-functional R&D teams, the Director will integrate pharmacology, toxicology, biomarker, and clinical insights to define development strategies, identify and mitigate risks, and enable data-driven decisions that advance novel therapeutics for patients.

This person will also

  • Provide strategic and scientific leadership for nonclinical safety and translational science, informing portfolio decisions, development strategy, and regulatory interactions.
  • Partner with Pharmacology, Clinical Development, Biomarkers, and other functions to establish integrated plans that connect mechanism, exposure, pharmacodynamic activity, safety, and clinical translation.
  • Represent Nonclinical and Translational Science on cross-functional project teams, providing clear recommendations and proactively addressing program risks and evidence gaps.
  • Evaluate external assets and technologies for potential in-licensing opportunities in partnership with Business Development and cross-functional subject matter experts.
  • Provide expertise in Immunology concepts, application to program design and strategy, and clinical translation and progression.

Responsibilities

  • Lead nonclinical and translational studies for assigned programs from candidate nomination through IND-enabling development, regulatory submission.
  • Support the clinical teams on first-in-human studies and subsequent clinical development.
  • Develop and maintain integrated nonclinical development plans, including pharmacology, toxicology, immunotoxicology, safety pharmacology, toxicokinetics, bioanalytical, immunogenicity, and translational activities aligned with program objectives and regulatory expectations.
  • Define translational strategies that connect preclinical findings to clinical h

[…]
compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

Base salary is one component of Amylyx’s total rewards package. In addition to competitive base pay, eligible employees may receive annual performance-based bonuses and equity awards, providing an opportunity to share in the company’s long-term success. Amylyx also offers a comprehensive benefits package designed to support the health, well-being, and financial security of our employees.

Estimated Pay Range
$216,000 — $243,000 USD

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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.