Senior Director, Toxicology

The Opportunity

The Senior Director Toxicology will support the strategy, design, and execution of nonclinical safety programs to aid in the development of drug candidates from IND-enabling studies 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 the translation of new therapeutics candidates.

Responsibilities

• Serve as a toxicology leader across a diverse and expanding pipeline spanning multiple therapeutic areas and drug modalities, shaping nonclinical safety strategy from discovery to IND-enabling and throughout clinical phases.
• Partner closely with Discovery Biology, Bioanalytical and Translational Science, Program Management, Regulatory, Clinical Development, Clinical Operations, and Leadership teams to accelerate advancement of high-impact therapies to patients.
• Build and scale toxicology capabilities with a high collaborative, and science-driven organization where strategic thinking agility, audacious goals, accountability, and scientific excellence are highly valued.
• Drive innovative and fit-for-purpose safety assessment approaches that enable efficient development timelines while maintaining rigorous scientific and regulatory standards.
• Influence the future direction of the pipeline by integrating emerging toxicology science, translational approaches, and regulatory expectations into development strategy.
• Mentor and develop scientific talent while fostering a culture of accountability, collaboration, and continuous learning.

Required Qualifications

• PhD in Toxicology, Pharmacology, Molecular or Cell Biology, or a related science.
• Minimum experience of 10-12 years industry experience in toxicology and nonclinical drug development following completion of PhD or post doc.
• DABT certification is desirable.
• Demonstrated experience developing and executing nonclinical safety strategies to support drug discovery, candidate selection, IND-enabling studies, regulatory submissions, and clinical development.
• Broad knowledge in field of toxicology, with practical knowledge of pharmaceutical toxicology. Direct experience with targeted delivery approach, rare disease development, endocrine and/or neuromuscular indication is desirable.
• Expert-level knowledge of global preclinical and clinical regulatory guidelines. Experience authoring, reviewing, and contributing to regulatory submissions and interactions with global health authorities.
• Demonstrated ability to interpret complex toxicology and nonclinical data and translate findings into actionable development strategies.
• Highly experienced leading external CROs, consultants, and multidisciplinary scientific teams to successfully deliver nonclinical development objectives.
• Demonstrated success working in cross-functional program teams.
• Strong and independent organizational skills, with excellent written, verbal, and presentation abilities to effectively communicate scientific concepts to diverse audiences including executive leadership.

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, Hawaii, Michigan and Tennessee.

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.

Compensation

The pay range posted below represents our good faith estimate of 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.

Estimated Pay Range
$269,000 - $291,667 USD

To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.

To return to our website please click here.

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.