[Remote] Senior Medical Director, Clinical Development at Amylyx Pharmaceuticals

Cambridge, Massachusetts, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Candidates must hold an MD degree and possess at least 4 years of experience in late-stage clinical development and drug development, with a strong preference for experience in rare diseases. The role requires the ability to lead pivotal programs and potentially manage a small team of clinical scientists and physicians.

Responsibilities

The Senior Medical Director will provide medical monitoring for assigned clinical trials in serious endocrine conditions, neurodegenerative, or rare diseases. This includes developing and implementing Clinical Development Plans, designing and executing clinical studies, and interpreting study data. Responsibilities also encompass interacting with multidisciplinary teams, ensuring clinical and scientific issues are addressed, contributing to translational activities, operationalizing studies, monitoring data integrity, identifying trial conduct issues, and performing medical review and analysis of data for regulatory documents and publications. The role involves engaging with internal stakeholders, external medical experts, regulatory authorities, alliance partners, and vendors, as well as contributing to business development and organizational initiatives.

Skills

Clinical Development

Clinical Trial Design

Clinical Study Execution

Data Interpretation

Medical Monitoring

Translational Activities

Pharmaceutical Development

Matrix Work Groups

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.

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