Senior Vice President - Clinical Development

March 5

🍂 Massachusetts – Remote

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

⏰ Full Time

🟠 Senior

👔 Vice President

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Amylyx Pharmaceuticals

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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.

ALS • Neurodegenerative Diseases • Amyotrophic Lateral Sclerosis

201 - 500 employees

Founded 2020

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• 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. • Today, Amylyx is a pharmaceutical company based in Cambridge, Massachusetts, that is dedicated to the discovery and development of potential treatments for diseases including Wolfram syndrome, progressive supranuclear palsy (PSP), and amyotrophic lateral sclerosis (ALS). At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable. Our mission would not be possible without each individual perspective within our team. It's a culture that uses unconventional thinking for unsolved problems. • 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. • 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. • 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.

🎯 Requirements

• 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