Amylyx Pharmaceuticals

Senior Vice President, Clinical Development

Cambridge, MA · Exec

Sponsorship not specified$416k-$468kDetected 15 days ago

Data AnalysisBusiness DevelopmentRecruitingClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationRegulatory Affairs

About the role

In addition, this individual will participate in various business development evaluations, as applicable.
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.
Clinical Trial Oversight: Oversee the design, execution, and analysis of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
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.
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.
Develop and implement comprehensive clinical development strategies aligned with Amylyx's mission and business objectives.
Oversee the design, execution, and analysis of clinical trials, ensuring adherence to timelines, budgets, and regulatory requirements.
Establish and maintain relationships with key opinion leaders, clinical investigators, and external partners to support clinical programs.

Communication Skills: Excellent verbal and written communication skills, with the ability to effectively present complex information to diverse audiences.
In-depth understanding of global regulatory requirements and experience with regulatory interactions and submissions.

MD or MD/PhD with specialization in Neurology or Endocrinology preferred.
Minimum of 15 years in clinical development within the biotechnology or pharmaceutical industry, with significant experience leading teams in rare disease drug development.

Regulatory Knowledge: In-depth understanding of global regulatory requirements and experience with regulatory interactions and submissions.
Communication
Excellent verbal and written communication skills, with the ability to effectively present complex information to diverse audiences.
Work Location and Conditions
Compensation
Estimated Pay Range
$416,000 - $468,000 USD
To stay connected with us, follow Amylyx Pharmaceuticals on LinkedIn.
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Accommodations are available for candidates who require them in our selection process.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment.
An employer who violates this law shall be subject to criminal penalties and civil liability.

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$416,000 - $468,000 USD
Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Collaborate with regulatory affairs to develop and execute strategies for regulatory submissions and interactions with health authorities.
Team Management: Lead and mentor a multidisciplinary team of medical directors, pharmacologists, and clinical development scientists, fostering a culture of collaboration and excellence.
The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs.
We are a clinical-stage company currently focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).
Our mission is powered by our people.

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy-related condition

This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.