Medical Director, Clinical Development
Abata TherapeuticsSalary not specified
Full Time
Senior (5 to 8 years)
[Remote] Medical Director, Clinical Development at Amylyx Pharmaceuticals
Cambridge, Massachusetts, United States
Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, BiotechnologyIndustries
Requirements
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.
Responsibilities
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.
Skills
Clinical Development
Clinical Trial Design
Clinical Study Execution
Data Interpretation
Translational Activities
Medical Monitoring
Amylyx Pharmaceuticals
Develops treatments for neurodegenerative diseases
About Amylyx Pharmaceuticals
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.
Cambridge, MassachusettsHeadquarters
2013Year Founded
$166.7MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
Benefits
Remote Work Options
Risks
Relyvrio's Phase III failure raises concerns about ALS treatment efficacy.
Low stock offering price suggests potential financial instability.
New CCO may disrupt commercialization strategies if not aligned with goals.
Differentiation
Amylyx focuses on neurodegenerative diseases like ALS and Alzheimer's.
AMX0035 is a promising drug for ALS and Alzheimer's treatment.
Amylyx engages in community awareness campaigns for neurodegenerative diseases.
Upsides
Positive Phase II results for AMX0035 in ALS boost its potential.
Partnership with Gubra accelerates drug development for neurodegenerative diseases.
Regulatory support for rare diseases aids Amylyx's Wolfram syndrome efforts.
Related Jobs
RemoteRemoteMedical Monitor- Hepatobilliary/Pancreatic cancer
Lindus HealthSalary not specified
- Part Time
- Expert & Leadership (9+ years)
RemoteDirector / Senior Director, Clinical Development Scientist
Abata TherapeuticsSalary not specified
- Full Time
- Expert & Leadership (9+ years)
RemoteDirector - Clinical Research Physician
Eli Lilly and CompanySalary not specified
- Full Time
- Expert & Leadership (9+ years)
RemoteClinical Research Physician- Oncology Global Medical Affairs
Eli Lilly and CompanySalary not specified
- Full Time
- Senior (5 to 8 years)