About Xylo: Xylo Bio is developing targeted neurotherapeutics to transform the lives of patients with neurological and psychiatric conditions. By combining advanced neuroscience with computational drug discovery, Xylo is evolving a category-defining GPCR platform to produce neuroplastogens capable of rewiring neural circuits and restoring brain function.
Responsibilities
Clinical & Regulatory Strategy:
• Provide expert guidance on clinical strategy and trial design, indication selection, and regulatory strategy for novel neuropsychiatric therapeutics
• Advise on biomarker strategy, patient recruitment, and trial endpoints to optimize clinical outcomes and regulatory approvals
• Offer insights into FDA, EMA, and TGA regulatory pathways, including Breakthrough Therapy, Fast Track, and Orphan Drug designations where applicable
• Help shape medical affairs strategy, patient engagement initiatives, and scientific communications
Scientific & Medical Leadership:
• Assist in prioritizing lead programs based on clinical feasibility, unmet medical need, and commercialization potential
• Leverage knowledge of CNS disorders, neuropsychiatry, or neurology to refine the clinical development roadmap
• Guide the company in risk mitigation strategies for development and regulatory interactions
• Act as a mentor and scientific advisor to Xylo’s clinical leadership, supporting the transition from preclinical to clinical-stage biotech
• Provide market intelligence on competitive landscapes, reimbursement, and commercial viability of Xylo’s pipeline
• Leverage professional networks to introduce Xylo to strategic partners and key opinion leaders (KOLs) in neuropsychiatry and drug development
Qualifications Clinical Development and Leadership:
• MD or MD/PhD in psychiatry, neurology, neuroscience, or a related field
• Extensive experience in clinical-stage biotech or pharmaceutical CNS drug development, ideally in neuropsychiatry, neurology, or neuropharmacology.
• Strong track record in leading clinical trials in the pharmaceutical industry (Phase I-III) and interacting with global regulatory agencies.
• Current or recent leadership role in clinical development, regulatory affairs, or medical affairs at a commercial-stage pharma or venture-backed biotech.
• Experience in clinical translation of novel neurotherapeutics, including small molecules
• Prior experience serving on scientific advisory boards, clinical development committees, or corporate boards within the biotech industry.
• Strong network within CNS-focused pharma BD, and KOL communities
Regulatory & Commercial Expertise:
• Familiarity with regulatory approvals and clinical trial execution across multiple jurisdictions (FDA, EMA, TGA).
• Strategic insight into clinical endpoints, patient stratification, and biomarker-driven approaches in CNS disorders.
• Prior involvement in patient-centered drug development and understanding of payer/reimbursement landscapes for CNS therapeutics.
• Familiarity with neuroplastogen development or next-gen psychiatric drug innovation nice to have but not required
Engagement
• Location flexible; must be able to work across time zones with team members in the US and Australia as well as contract research organizations in Europe
• Engagement: ~4-8 hours per month, as required
• Meetings: Attend quarterly CAB meetings, review clinical/regulatory materials, and provide strategic feedback
• Collaboration: Ongoing phone and email discussions with senior leadership team to advise on clinical development strategy
