Head, Medical Director, Clinical Development

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:

• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• AMX0035 is currently under review with the European Medicines Agency
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022
• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!

Position Summary
The Head, Medical Director, Clinical Development will be the clinical development lead for assigned assets in Neurology primarily in early development. This position will also support the Clinical Development team in activities for planned late stage clinical trials. Reporting to the Head of Global Clinical Development, you are 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. 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.
Responsibilities

• Develops and maintains relationships with program counterparts in Research, Regulatory Affairs, Clinical Operations, Statistics and Contract Research Organizations (CROs).
• Provides clinical development leadership for programs that integrate extensive knowledge in clinical science and neurology, and inputs from the global medical community.
• Accountable for production of highest quality program related documents, including protocols, IBs, clinical study reports, briefing documents and drug labels.
• Integrates scientific rationale, regulatory requirements, product development plan, and value to patients and shareholders to build a solid Clinical Development Plan (CDP).
• Provides medical monitoring to assigned neurology clinical trials.
• Gene therapy and knowledge of neuroscience biomarkers are a plus.
• Develops Go/No Criteria for early stage programs to enter late stage development.
• Contributes to specific Business Development activities and various organizational initiatives in Clinical Development.
• Acts as the primary Clinical Development interface with internal stake holders as well as external subject matter experts and alliance partners for the assigned programs.

Requirements

• Excellent communication skills (oral and written) and organizational skills.
• 3+ years of experience with gene therapy focused clinical development programs in the pharmaceutical industry.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• MD (Neurology) required, with clinical or research experience in neuroscience.
• 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.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.