Head, GCP/Clinical Quality Assurance

Amylyx Pharmaceuticals offers a unique opportunity to be part of a team that is truly building a company from the ground up! Currently under 25 FTEs, you will play a key role in both launching a new drug for ALS and launching a company that has potential to shape the way medicines are created in the Cambridge (and beyond) biotech community. Together, with our growing leadership team of industry veterans, we relentlessly drive forward to help patients and refuse to accept the standard approach.

Amylyx Pharmaceuticals was started in 2013 by 2 students at Brown University. The company remains founder lead with a strong entrepreneurial culture. Today we are a clinical-stage pharmaceutical company developing a novel therapeutic for Amyotrophic Lateral Sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases. AMX0035 is a first-in-class investigational therapy designed to reduce neuronal death and dysfunction. AMX0035 targets mitochondrial and endoplasmic reticulum-dependent neuronal degeneration pathways.  In recently announced results from the CENTAUR study, Amylyx’ first in class investigational therapy, AMX0035, demonstrated a significant treatment benefit for people with ALS. These results mark a significant step forward in the fight to develop new treatments for ALS. 

In June we announced enrollment of our phase II PEGASUS trial assessing AMX0035 in Alzheimer’s disease.

In September, AMX 0035 phase 2 ALS data were published in the New England Journal of Medicine.

In October, AMX 0035 survival data were published in the journal Muscle and Nerve.

With these results, Amylyx now has a responsibility to move ahead as efficiently as possible, as people living with ALS do not have time to wait. We are bringing together a team dedicated to fearless innovation, and who believe together we can achieve our goal of helping patients.

We provide a comprehensive employee benefits package including pre-IPO stock options. If you are patient focused and inspired to find new ways for treating neurodegenerative diseases, Amylyx is the place for you! 

Description

The Head, Clinical Quality Assurance oversees all aspects of GCP QA activities internally at Amylyx as well as Investigator Sites and CROs and GCP Vendors.  In this role you will lead or oversees GCP activities and lead GCP inspection readiness. The successful candidate will ensure high quality execution of clinical trials from first in human through commercial marketing authorization. In this role you will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative on clinical teams.  This newly created role is a high visibility position with great impact potential.

Responsibilities:

• Proactively provide GCP QA support for clinical development activities to protect patient safety and wellbeing, maintain data integrity, and support operational excellence
• Work closely with Amylyx’s stakeholders to drive compliance with GCP, GLP and GVP regulations from Sponsor perspective
• Write, review and revise SOPs related to clinical trials according to applicable global GCP, GLP and GVP regulations
• Manages and supports internal audits of GCP, GLP and GVP functions
• Participate in meetings where clinical trials activities are discussed and guide the team in decision making to meet regulatory requirements
• Independently conducts, co-audits or oversees and manages Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files), internal Process Audits and support Vendor/System audits
• Author and manage GCP Audit Plans and Audit reports, as needed
• Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams, follow up on CAPAs from audits
• Manage health authority inspection preparation activities and provide leadership and oversight during GCP inspections
• Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
• Compile and analyze audit metrics to communicate trends to business groups
• Conduct GCP training sessions for business groups
• Manage direct reports (contractors and employees if applicable)

Qualifications:

• Bachelor’s degree or equivalent medical professional experience in nursing, pharmacy, medical technology discipline.
• 8 – 10 years of Clinical Quality Assurance (CQA) and experience in working with clinical research/operations/data management/pharmacovigilance or related areas
• Experience in working with global CROs
• Experience working within Sponsor organizations
• Technical and administrative capabilities to independently carry out routine, complex and for-cause audits
• Experience with BIMO inspections
• Fundamental knowledge of US, EU and international regulatory standards and guidelines for the conduct of clinical trials
• Strong analytical skills and report writing skills
• Must have professional communications skills, strong independent time management skills and the ability to manage multiple projects concurrently
• Ability to travel approximately 20%