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).