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The Opportunity:
- Serve as the Clinical Pharmacology lead for assigned development programs from first-in-human through Phase 3.
- Provide deep expertise in PK/PD, exposure-response, and modeling and simulation activities.
- Collaborate with cross-functional teams and participate in regulatory agency meetings.
The Role:
- Develop and execute program-specific clinical pharmacology strategies aligned with overall development objectives.
- Design and oversee clinical pharmacology studies, including protocol development and analysis plans.
- Support preparation of regulatory submission documents and responses to health authority questions.
What You'll Bring:
- PhD, PharmD, or MD in Clinical Pharmacology or related field with 10-15+ years of industry experience.
- Strong understanding of PK/PD principles and experience with population PK and exposure-response analyses.
- Excellent scientific writing, presentation, and project management skills in a collaborative environment.
Why Amylyx:
- Work on transformative therapies for diseases with high unmet medical needs.
- Be part of a culture of caring, urgency, and audacious innovation.
- Enjoy remote work with occasional travel to Cambridge, MA and company events.
Amylyx
Amylyx is a clinical-stage biotechnology company focused on developing therapies for diseases with high unmet needs, including ALS, Wolfram syndrome, and post-bariatric hypoglycemia. The company fosters a culture of caring with core values of audacity, curiosity, authenticity, engagement, and accountability, and has assembled an experienced team ready to tackle tough medical problems.