Amylyx Pharmaceuticals

Associate Director, Clinical Compliance & Records

Cambridge, MA · Director

Sponsorship not specified$171k-$192kDetected 12 days ago

GCPExcelProcess ImprovementRecruitingClinical TrialsFDA RegulatoryLeadershipCommunicationCollaborationTime ManagementMicrosoft OfficeSharePointGxP

About the role

The Associate Director, Clinical Compliance & Records will work closely and collaboratively with Clinical Operations leadership and Study Management Teams (SMTs) to ensure that Amylyx clinical studies are conducted in compliance with Standard Operating Procedures (SOPs), ICH/GCP, and other applicable regulations.
Reporting to the Director, Clinical Compliance & Records, this role will participate in SMTs, providing leadership for TMF strategy and process, and partnering with internal and external stakeholders on inspection readiness initiatives, supporting management of overall compliance and identifying and implementing process improvement strategies.

Responsibilities

Apply clinical compliance knowledge to identify, assess, trend, and manage study-related risks and issues.
Lead or support investigations, CAPA activities, and continuous process improvement initiatives.
Partner with Clinical Operations and cross-functional SMT members to support Quality Event (QE) management, including maintaining Oversight Registers, facilitating risk and impact assessments, updating Risk Assessment Categorization Tools (RACTs), and ensuring the development and maintenance of sponsor oversight documentation, such as storyboards and supporting evidence packages.
Partner with SMTs and other members of the Clinical Compliance and Records team to create and maintain study-specific training matrices. Ensure SMT members are trained on appropriate study documents per study-specific training matrices.
Collaborate with Quality Assurance and Clinical Operations to ensure that Clinical Operations written standard operating procedures, forms, and templates meet the changing needs of the organization.
Create and manage a periodic review schedule, to ensure that Clinical Operations written SOPs, forms, and templates are assessed in a timely fashion and in conjunction with defined procedures.
Create and manage periodic review schedules for study plans and evaluations of adherence to defined processes.
Facilitate and support inspection readiness activities by collaborating with Clinical Operations, SMTs, and Clinical Quality to ensure appropriate preparation for, participation in, and follow-up from Regulatory inspections and internal audits.
Serve as support for and back-up to Director, Clinical Compliance and Records, providing guidance and leadership for the Clinical Compliance team and operations, ensuring alignment with departmental goals and organizational priorities.
Provide leadership for Clinical Records strategy, including management of electronic Trial Master File (eTMF) processes, procedural documents (e.g., SOPs, Work Instructions, User Guides), TMF Plans and associated indexes, TMF migrations, change controls, deviations and CAPAs.

Requirements

Experience with the interpretation and application of ICH/GCP standards and FDA guidelines to varying phases of clinical studies.
Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
Excellent interpersonal and professional skills and ability to work collaboratively across functional teams.
Must have the enthusiasm to work at a small company and work in a fast-paced environment and be ready to dive right in once hired.
Prior experience as a Business Administrator over electronic Trial Master File systems.

Nice to have

High level of competency with TMF Standard (i.e., TMF Reference Model), and working knowledge of Veeva Clinical and Veeva Quality workflows preferred.
Preferred Requirements

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks.
Estimated Pay Range
$171,000 - $192,000 USD
Amylyx's management team is dedicated to this policy with respect to recruitment, hiring, placement, promotion, transfer, training, compensation, benefits, employee activities, access to facilities and programs, and general treatment during employment.

Benefits

Monitor TMF health and provide study-specific metrics according to the TMF Plan.
Bachelor's Degree in a health related or scientific discipline with 8+ years of pharmaceutical or biotechnology industry experience, working in Clinical Compliance and/or TMF focused roles.
The final offer may vary depending on a candidate's experience, skills, and qualifications, as well as considerations of internal equity.

Company info

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

Equal opportunity

If you need an accommodation, please let your Amylyx Talent Acquisition contact know.

Visa & Work Authorization

act assessments, updating Risk Assessment Categorization Tools (RACTs), and ensuring the development and maintenance of sponsor oversight documentation, such as storyboards and supporting evidence packages

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This listing is sourced directly from Amylyx Pharmaceuticals's careers page and normalized into a canonical job model.