Senior Director, Clinical Pharmacology

Summary

Join Amylyx Pharmaceuticals as their Senior Director of Clinical Pharmacology, leading and supporting the clinical pharmacology team. You will be accountable for the overall strategy in determining the PK, PD, and immunogenicity properties of all drugs and drug candidates. As the clinical pharmacology expert, you will lead, develop, and educate cross-functional teams, contributing to diligence assessments. Reporting to the SVP, Head of Clinical Development, you will have high visibility within the company. You will synthesize internal and external data to create a clinical pharmacology strategy. This role offers remote work opportunities within the United States, with occasional travel to Cambridge, MA.

Requirements

• PhD, PharmD, MD, or equivalent training in pharmacokinetics, pharmaceutical sciences, or related disciplines
• Minimum 10 years of experience within the pharmaceutical and biotechnology industry with 5+ years' direct experience in Clinical Pharmacology
• Experience in an array of molecules including biologics, small molecules and gene therapy
• Demonstrated experience in writing, presenting, and discussing clinical pharmacology with regulatory authorities as well as other external and internal stakeholders
• Strong analytical skills and ability to interpret complex clinical data sets as well as deep understanding of individual patient data coupled with excellent written and verbal communication skills
• Ability to work in cross-functional teams and manage multiple projects, engaging subject matter experts across functions to drive the execution of programs
• Strong technical proficiency in PK analysis (NCA and PopPK)
• Ability to work with an elevated level of integrity, accuracy, and attention to detail, while executing corporate objectives and goals
• Entrepreneurial, enjoys working in a fast-paced, small-company environment

Responsibilities

• 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, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
• 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
• Ensure appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program
• Collaborates with toxicologist and preclinical pharmacology scientists to design, analyze, interpret, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-human studies
• Ensure adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs
• Serves as the clinical Pharmacology expert across study and program teams
• Develops and implements new clinical pharmacology approaches to processes and clinical studies that impact development programs
• Contributes to program strategy, study design, protocol preparation, study execution, data review/analysis, study reports and regulatory document preparation
• Works closely with research and development teams and provides input into assay development, CRO selection and CRO management
• Represents nonclinical and clinical pharmacology during meetings and discussions with regulatory authorities
• Creates or guides nonclinical and clinical pharmacology summary documents
• 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

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