Medical Director, Clinical Development

July 30

🐻 Alaska – Remote

Although this job is listed in Alaska, this company may be open to hiring remote in other states.

🌵 Arizona – Remote

Although this job is listed in Arizona, this company may be open to hiring remote in other states.

+2 more states

🐻 Alaska – Remote 🌵 Arizona – Remote 🌺 Hawaii – Remote 🌪️ Kansas – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Amylyx Pharmaceuticals

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Biotechnology • Pharmaceuticals

Amylyx Pharmaceuticals is a company dedicated to discovering and developing innovative treatments for diseases with high unmet needs. They focus on conditions such as Amyotrophic Lateral Sclerosis (ALS), Post-Bariatric Hypoglycemia (PBH), Wolfram Syndrome, and Progressive Supranuclear Palsy (PSP). Amylyx is committed to supporting patients and their loved ones, creating more moments of significance for them. They have recently acquired a Phase 3-ready GLP-1 receptor antagonist with FDA Breakthrough Therapy Designation and have shown positive results in clinical trials for Wolfram syndrome. The company emphasizes transparency, setting realistic expectations, and collaborating to make impactful changes in the treatment of neurodegenerative diseases.

201 - 500 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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.

🎯 Requirements

• MD required • Experience with late-stage clinical development and drug development in rare diseases strongly preferred • 4+ years of experience in leading clinical development programs in the biotechnology/pharmaceutical industry with a proven record of achievements. • Ability to think critically and demonstrate troubleshooting and problem-solving skills. • Demonstrated leadership and team building skills as well as the ability to perform effectively in a multi-disciplinary environment. • Ability to lead directly and by influence, including strong interpersonal, problem solving, conflict resolution and analytical skills in a matrix environment. • Excellent communication skills (oral and written) and organizational skills. • Ability to travel internationally and domestically

🏖️ Benefits

• At Amylyx, we proudly support remote work opportunities within the United States. • However, due to business considerations related to health insurance coverage and state tax regulations, we are unable to hire employees who reside and/or work in certain states. Currently, we are not considering applicants from Alaska, Arizona, Delaware, Hawaii and Kansas. • You will be expected to travel to our corporate location in Cambridge, MA several times a year and attend other company-related events as necessary and requested. • You must have access to work in setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location.