Senior Director, Preclinical Research

THE OPPORTUNITY

As the ambitious pipeline at Amylyx Pharmaceuticals continues to grow, there is a need for a Head of Preclinical Research to lead our R&D organization, reporting to our co-CEOs.

Everything we do is centered around those living with diseases with high unmet needs and their loved ones. We are on a mission to discover and develop innovative treatments and to help support and create more moments for these communities. Our sense of urgency in this mission begins on day one in the preclinic. This role will be responsible for leading our efforts to bring high-potential science to clinic at a rapid pace and supporting continued nonclinical studies as compounds advance to market.

R&D at Amylyx was founded on an outsourcing model, and that approach has remained a strong foundation as we have grown into a global company. We build our pipeline through a combination of internally developed programs and external collaborations with academic and contract research organization (CRO) partners.

This is a hands-on role, requiring the ability to move between strategic and operational effectiveness. The successful candidate will be comfortable taking a non-traditional, collaborative, and cross-functional approach to continue expanding the Amylyx pipeline. Such an approach will involve oversight of and leadership in the identification and review of novel therapeutic targets, as well as the design, execution, and analysis of nonclinical studies required to bring new therapies from bench to bedside for people living with rare diseases.

The ideal candidate will bring leadership experience as well as technical and strategic expertise, in addition to collaborative, flexible, and positive work and management styles. He/she will have experience leading research teams and will be comfortable planning, overseeing, and troubleshooting drug discovery efforts in disease areas with high unmet need. He/she will also have experience interfacing with colleagues in clinical operations and clinical development during translational steps to clinic, as well as with regulatory writing to support submissions to health agencies.

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)

REQUIRED QUALIFICATIONS

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

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, Delaware, Hawaii and Kansas.
• 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.