Clinical Development Lead, Transplant Expansion / New Indications
BiogenFull Time
Senior (5 to 8 years)
Candidates must possess an MD and have at least 4 years of experience in leading clinical development. Experience with late-stage clinical development and drug development in rare diseases is strongly preferred.
The Medical Director will provide medical monitoring for assigned clinical trials, lead the development and implementation of Clinical Development Plans, and oversee clinical study design and execution. They will interpret study data, interact with multi-disciplinary teams, and manage relationships with internal stakeholders, external experts, and alliance partners. Responsibilities also include contributing to translational activities, operationalizing studies, monitoring data integrity, and producing high-quality program-related documents.
Develops treatments for neurodegenerative diseases
Amylyx Pharmaceuticals develops treatments for neurodegenerative diseases, focusing on conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's Disease (ALZ). Their main product, AMX0035, is currently undergoing clinical trials to assess its effectiveness. The CENTAUR ALS trial showed promising results for ALS patients, using a randomized, double-blind, placebo-controlled design to ensure reliable outcomes. They are also conducting the PEGASUS trial to evaluate AMX0035's safety and effectiveness in Alzheimer's patients. Unlike many competitors, Amylyx emphasizes community engagement and awareness campaigns, such as ALS Awareness Month, to educate the public and foster support for those affected by these diseases. The company's goal is to bring effective therapies to market that improve patient outcomes and enhance the quality of life for individuals suffering from neurodegenerative conditions.