Vice President, Clinical Pharmacology

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS). The Vice President of Clinical Pharmacology will provide leadership and support to the clinical pharmacology team and be accountable for the overall strategy for determining the PK, PD, and immunogenicity properties of all drugs and drug candidates in development and, as applicable, through commercialization.

Requirements

• Serve as the clinical pharmacologist for the company across all clinical programs, providing strategic and scientific input from preclinical development through Phase 3 trials
• Lead the Clinical Pharmacology team accountability for the clinical pharmacology strategy for Amylyx' development portfolio from pre-IND through and post approval
• Integrate clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions
• Collaborates with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies
• Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Represents nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
• Reviews literature and peer-reviewed publications to keep apprised of global regulatory developments in clinical pharmacology; Authors/ reviews manuscripts for submission to peer-reviewed journals

Benefits

• 401k Matching
• Retirement Plan
• Generous Paid Time Off
• Visa Sponsorship
• Relocation Assistance
• Generous Parental Leave