THE OPPORTUNITY

The Senior Vice President (SVP) of Clinical Development will provide strategic direction and technical leadership to the clinical development team, including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. In addition, this individual will participate in various business development evaluations, as applicable. 

Overall, the main responsibility will be to provide strategic leadership for the clinical and medical aspects for the various programs and work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products.   Furthermore, this individual will have the opportunity to oversee the clinical development of multiple product candidates that represent different modalities and are at different stages of development from first in human to pivotal trials. 

RESPONSIBILITIES

• Strategic Leadership: Develop and implement comprehensive clinical development strategies aligned with Amylyx's mission and business objectives.
• Team Management: Lead and mentor a multidisciplinary team of medical directors, pharmacologists, and clinical development scientists, fostering a culture of collaboration and excellence.
• Clinical Trial Oversight: Oversee the design, execution, and analysis of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
• Regulatory Engagement: Collaborate with regulatory affairs to develop and execute strategies for regulatory submissions and interactions with health authorities.
• Stakeholder Collaboration: Establish and maintain relationships with key opinion leaders, clinical investigators, and external partners to support clinical programs.
• Budget Management: Develop and manage the clinical development budget, ensuring optimal resource allocation and fiscal responsibility.

REQUIRED QUALIFICATIONS

• Educational Background: MD or MD/PhD with specialization in Neurology or Endocrinology preferred.
• Experience: Minimum of 15 years in clinical development within the biotechnology or pharmaceutical industry, with significant experience leading teams in rare disease drug development. Successful BLA/NDA/MAA submission(s) and clinical/medical support of product commercialization preferred.
• Leadership Skills: Proven ability to lead cross-functional teams, foster cross-functional collaboration and manage multiple projects in a fast-paced environment.
• Regulatory Knowledge: In-depth understanding of global regulatory requirements and experience with regulatory interactions and submissions.
• Communication Skills: Excellent verbal and written communication skills, with the ability to effectively present complex information to diverse audiences

WORK LOCATION AND CONDITIONS

• While this is a remote role, preference will be given to candidates who reside within New England and can attend meetings at our office in Cambridge, MA on a regular basis.
• When working remotely, you must have access to a work setting which enables meeting all requirements of the role (including privacy, reliable internet access, phone, ability to video conference, etc.) at your remote location
• 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.