Medical Director, Clinical Development

Amylyx is seeking a Medical Director, Clinical Development to be the lead for a late-stage, pivotal program that has the potential to expand to additional programs with the same molecule. This program may be the first of several for this molecule given the mechanism of action of the drug. Opportunities to lead additional development programs with other assets also may arise, together with leading a small team of clinical scientists and physicians. Reporting to the Senior VP of Clinical Development, you will be responsible for medical monitoring for assigned clinical trials, the development and implementation of the Clinical Development Plan for the assigned assets, including clinical study design and execution, as well as interpretation of study data. The successful candidate will interact within a multi-disciplinary, matrix work group including research, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall clinical development plans. You will be involved in potential translational activities, operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications. In this role you will interact with multiple functions and management within Amylyx, and with external stakeholders including the global medical expert community, global regulatory authorities, alliance partners and vendors.