Amylyx

Senior Medical Director, Clinical Development

Cambridge, MA. Posted 15 months ago

The role

The Senior Medical Director provides strategic and scientific leadership for late-stage, pivotal clinical programs. This person leads the design, execution, and interpretation of clinical studies and oversees Clinical Development Plans.

What you will do

  • Provides strategic medical leadership and oversight for assigned clinical programs
  • Leads development and execution of Clinical Development Plans
  • Drives study design, protocol development, and interpretation of complex clinical data
  • Serves as a core member of cross-functional program teams
  • Provides senior-level medical monitoring and guidance
  • Leads interactions with external stakeholders including key opinion leaders, investigators, regulatory agencies, and alliance partners
  • Oversees preparation of key program documents including protocols, investigator brochures, clinical study reports, regulatory submissions, and publications
  • Mentors and provides scientific guidance to junior team members
  • Identifies and implements process improvements and best practices

Required qualifications

  • MD and Residency Experience Required
  • Significant experience in late-stage clinical development and drug development in biotech/pharmaceutical industry
  • Ability to travel internationally and domestically (approximately 10%)
  • Demonstrated ability to collaborate with cross-functional teams and influence without authority in a matrix environment
  • Strong strategic thinking, problem-solving, and decision-making skills
  • Proven ability to interpret complex clinical data and translate insights into actionable strategies
  • Excellent communication and leadership skills
  • Experience interacting with senior stakeholders and external experts
  • Access to work in setting that meets all requirements including privacy, reliable internet access, phone, and ability to communicate via video conference

Nice to have

  • neurology, endocrinology, or rare disease experience strongly preferred
  • Experience mentoring or leading team members preferred

Benefits

  • Competitive base pay
  • 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

About the company

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

Senior Medical Director, Clinical Development at Amylyx | JobZoey