Senior Director, Preclinical Research

Summary

Join Amylyx Pharmaceuticals as the Head of Preclinical Research, leading the R&D organization and reporting to the co-CEOs. This role is crucial in driving high-potential science to the clinic at a rapid pace and supporting continued nonclinical studies as compounds advance to market. You will manage the internal preclinical research team, work cross-functionally with internal departments, and manage external consultants in various functions. The ideal candidate will have extensive experience in pharmaceutical or biotechnology environments, including hands-on experience in early drug development, and a proven track record of leading teams through IND-enabling studies and regulatory filings.

Requirements

• PhD or MD required
• 10+ years' experience in a pharmaceutical or biotechnology environment, including hands-on experience in scientific research activities in early drug development
• Experience leading a team through IND-enabling studies, as well as regulatory filings and interactions
• Team leadership skills and experience in a complex matrix environment. Excellent relationship-building skills and ability to collaborate to achieve a desired outcome
• Excellent written and oral communication skills; demonstrated ability to convey complex scientific concepts to a wide variety of audiences
• Comfortable with risk-taking and troubleshooting potential failures, and able to work in a fast-paced, outsourced environment

Responsibilities

• Manage Amylyx internal preclinical research team
• Work cross-functionally with internal departments including technical operations, regulatory, program management, clinical, and others to advance assets through the drug development process
• Manage external consultants in functions including bioanalysis, bioinformatics, medicinal chemistry, toxicology, and biostatistics
• Provide guidance to small internal team responsible for novel target identification through review and analysis of scientific literature
• Generate program-specific development plans to chart a path to IND-enabling studies
• Lead experimental design and data analysis
• Identify and develop partnerships with academic institutions and research organizations globally that can support and accelerate Amylyx’ translation of early-stage, high-potential programs to clinic
• Provide oversight for and management of academic labs, CROs, and other external partners
• Author or support the authoring of nonclinical sections of regulatory submissions (e.g., INDs, CTAs, IBs, briefing books)
• Serve as nonclinical representative at meetings with regulatory agencies
• Support the selection of pharmacodynamic endpoints and assessment strategy during clinical development
• Contribute to the preclinical evaluation of disease indications for clinical pipeline and early discovery programs
• Provide scientific input to guide Amylyx’ strategic development roadmap and support overall corporate strategy
• Provide subject matter expertise to diligence on external assets and potential in-licensing opportunities
• Manage resource allocation within early-stage R&D efforts in accordance with internal budgets and business objectives
• Present the company’s research internally (e.g., at all-company meetings) and external (e.g., at conferences, in business development discussions, during meetings of the Board of Directors)

Preferred Qualifications

• Experience with successful INDs and NDAs is a plus
• Expertise/experience with neurodegenerative diseases and ASO therapeutics is a plus

Benefits

• At Amylyx, we proudly support remote work opportunities within the United States
• 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