Head, Clinical Compliance Jobs

Amylyx was started in 2013 by two Brown University students who had an ambitious goal: to improve the lives of people with neurodegenerative diseases by addressing the root cause. Their research and close collaboration with the ALS community ultimately resulted in our first commercial product, which is now approved in the U.S. and conditionally approved in Canada.
At Amylyx, we’re bringing together talented people like you who are guided by our values to be Audacious, Curious, Authentic, Engaging and Accountable in the fight against neurodegenerative diseases like, ALS, Alzheimer’s disease, Wolfram Syndrome and others.
Rediscover your purpose and reimagine your career at a company whose founders, mission, and culture are unlike any other in life sciences—in all the best ways.
Recent milestones include:

• AMX0035 is currently under review with the European Medicines Agency
• The U.S. Food and Drug Administration (FDA) approved RELYVRIO™ in September of 2022
• 280 employees globally, with headquarters in Cambridge, MA, US and Amsterdam, the Netherlands -- and growing strong!
• Health Canada approved ALBRIOZA™ with conditions in Canada in June of 2022

Position Summary
Amylyx Pharmaceuticals, Inc. is seeking a creative, resourceful, and collaborative Clinical Compliance leader within Clinical Operations. The Head of Clinical Compliance collaborates with Clinical Operations, R&D, Quality Assurance, Medical Affairs, Safety, and other cross-functional departments to provide ICH/GCP guidance and direction related to clinical trial conduct, oversight, and risk management as prescribed by regulatory guidance and Amylyx standard operating procedures.
The Head of Clinical Compliance will provide effective leadership, and direction to internal and external resources to implement best clinical practices and ICH/GCP guidance within Clinical Operations. The role involves overseeing the management and maintenance of clinical quality management systems associated with standard operating procedures, process improvement, training, and risk management. This key role will also lead ongoing inspection readiness by completing or overseeing Clinical Operations performance health checks, Quality Control reviews, supporting the development and review of inspection readiness tools, and participating in regulatory inspection preparation activities. The Head of Clinical Compliance supports Clinical Operations in collaborating with Quality Assurance to implement process improvement strategies.
Responsibilities

• Collaborate and develop strong relationships with personnel from Clinical Operations, Quality Assurance, and other Amylyx stakeholders to facilitate and support process improvement, risk management, and inspection readiness activities.
• Collaborate with Quality Assurance to ensure that Clinical Operations written standard operating procedures, forms, and templates meet the changing needs of the organization.
• Engage with Research and Development, Pharmacovigilance, and Clinical Operations to proactively evaluate and mitigate GCP risks from study conceptualization through completion. This may include reviewing study protocols, regulatory submission documentation and engaging in project planning and development meetings.
• Serve as the Clinical Compliance representative for selected clinical study teams. Apply ICH/GCP guidance and clinical compliance knowledge to varying stages of clinical research, including risk identification/management, investigation/CAPA activities, and protocol deviation assessment.
• Identify and escalate significant quality and compliance risks to leadership within Clinical Operations and Development, Quality Assurance, and Corporate Compliance. Participate in investigation and mitigation measures.
• Facilitate and support inspection readiness activities in Clinical Operations. Complete Performance Health checks and support mitigation actions through the development and revision of new tools and process improvement.
• Provide ICH/GCP clinical compliance consultation and support to Amylyx Clinical Operations and their stakeholders. Maintain current knowledge related to ICH/GCP guidelines and regulations and Amylyx standard operating procedures.
• Provide support during and following Regulatory inspections and internal audits.

Requirements

• Possesses the ability to serve as a mentor to increase quality culture across departments.
• Must demonstrate leadership and executive problem-solving skills, while remaining approachable, flexible, proactive, resourceful, and efficient.
• Advanced Degree, MS, MBA or PHD is preferred.
• Proactive and self-driven to achieve on time personal goals, as well as to help others achieve desired outcomes and resultsAbility to work individually and within a multi-disciplinary team
• Strong, enthusiastic, and collaborative team member that is solution oriented
• Must be capable of analyzing and presenting data trends.
• Must have effective interpersonal skills and the ability to work cross-functionally to develop and promote new initiatives and process improvement.
• Experience with the interpretation and application of ICH/GCP expectations and standards to varying phases of clinical studies
• Prior experience with global studies submitted for IND, MAA, or other regulatory submissions.
• 10+ years of pharmaceutical or biotechnology industry experience, with at least 5+ years working in a quality assurance or clinical compliance position supporting Clinical Operations.
• Possesses strong written and verbal communication skillsOrganized, analytical, and attentive to detail
• Prior experience with phase I-IV research studies.

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Amylyx is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical matters), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Accommodations are available for candidates who require them in our selection process. If you need an accommodation, please let your Amylyx Talent Acquisition contact know.