Director, Clinical Sciences

Amylyx Pharmaceuticals • Cambridge, MA

6d • Remote

About The Position

Amylyx has an audacious mission to usher in a new era for treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. 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. Our core values – be audacious, be curious, be authentic, be engaged, and be accountable – creating a culture of caring. Amylyx has assembled an experienced team ready to take action because the communities we serve have no time to wait. If you share our passion and are determined to tackle some of medicine’s toughest problems, we encourage you to read the opportunity below and apply.
The Opportunity
The Director Clinical Science will be a key member of the Clinical Development team with responsibilities to provide scientific support for ongoing activities. This role will report to a Medical Director and will collaborate cross functionally with R&D, program management, clinical operations, biostatistics, and data management. The selected candidate will support and drive key development activities for clinical studies and overall execution of program Clinical Development Plans (CDP).

Requirements

• Advanced degree (M.D., Ph.D., Pharm.D., Master’s Degree in Science/Medical-related field).
• MD, PhD or PharmD with 3+ years Clinical Research, Pharmaceutical, or CRO experience, OR Master’s degree with 8+ years of relevant experience.
• Knowledge of Phase 1-3 drug development.
• Knowledge of clinical trial implementation and sponsor/site interactions for clinical trials.
• Prior experience working within neurology or neurodegenerative 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.

Responsibilities

• 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 and 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, etc.
• 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 in the therapeutic areas as well as with internal management and drug development staff to prepare/revise/maintain and efficiently execute the clinical development plan.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 11-50 employees