Director, Clinical Sciences

The role

The Director, Clinical Sciences provides scientific support for ongoing activities and drives key development activities for clinical studies. This role supports the execution of program Clinical Development Plans and collaborates cross functionally with R&D, clinical operations, biostatistics, and data management.

What you will do

• Collaborates with the clinical development team in review, analysis, and interpretation of study results.
• Provides scientific support on ongoing Phase I to III clinical trials.
• Contributes to the planning and design of upcoming clinical studies.
• Performs monitoring and review of study data including labs, safety data, and patient eligibility.
• Authors and/or reviews clinical trial-related documents including protocols, CRF, informed consent, protocol deviations, monitoring plans and regulatory documents.
• Contributes to regulatory documents including CSRs, Investigator’s Brochures, and Clinical sections of INDs, CTAs.
• Interacts with external medical/scientific advisors, thought leaders and clinical investigators.
• Prepares, revises, maintains and executes the clinical development plan.

Required qualifications

• Master’s Degree in a relevant scientific or healthcare discipline
• Minimum of 8 years of relevant drug development experience
• Knowledge of Phase 1-3 drug development
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials
• Prior experience working within endocrine, neurology or rare disease indications
• Well-versed in relevant applications of GCP (Good Clinical Practice), ICH, FDA, EMEA and other relevant guidelines and regulations
• Strong, collaborative team-player
• Excellent attention to detail and communication skills

Nice to have

• Advanced degree (M.D., Ph.D., or Pharm.D.)
• Candidates who reside in the New England region

Benefits

• Annual performance-based bonuses
• Equity awards
• Comprehensive benefits package

Before you apply

• Unable to hire employees who reside and/or work in Alaska and Hawaii
• Must have access to work in setting which enables meeting all requirements of the role

About the company

Amylyx is a clinical-stage company focused on post-bariatric hypoglycemia (PBH), Wolfram syndrome, and amyotrophic lateral sclerosis (ALS).