Associate Director, Clinical Compliance & Records

Amylyx Pharmaceuticals; Cambridge (MA); On-site; USD 171,000 - 192,000; Full time

Benefits offered by this job

Remote-friendly work environment

Paid travel to corporate location

Comprehensive benefits package

Job summary

Amylyx Pharmaceuticals in Cambridge, MA is seeking an Associate Director of Clinical Compliance & Records responsible for ensuring compliance with clinical study regulations.

The ideal candidate will have extensive experience in the pharmaceutical industry, guiding Study Management Teams on ICH/GCP standards, and overseeing Trial Master File processes. A bachelor's degree in a science discipline is required, along with strong interpersonal and organizational skills.

Qualifications

• 8+ years of experience in pharmaceutical or biotechnology industry focused on Clinical Compliance.
• Experience with ICH/GCP standards and FDA guidelines.
• Enthusiastic about working in a fast-paced environment.

Responsibilities

• Guide SMTs on ICH-GCP standards and FDA guidelines.
• Lead investigations and CAPA activities.
• Ensure compliance with clinical trial regulations.

Skills

Interpersonal skills

Organizational skills

Communication skills

Time management skills

Education

Bachelor’s Degree in a health-related or scientific discipline

Tools

MS Office

Veeva Clinical

Job description

Associate Director, Clinical Compliance & Records

Cambridge, MA

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 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: Clinical Compliance

• Provide Study Management Teams (SMTs) with guidance on the application of ICH‑GCP standards, FDA guidelines, and other applicable regulatory requirements throughout the clinical trial lifecycle.
• 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. Escalate significant quality and compliance risks to departmental leadership.
• 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. This may include tracking of follow up actions resulting from inspections and 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.

Responsibilities: Clinical Records

• 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.
• Establish, follow, and oversee processes for TMF set up, maintenance, and archival across Amylyx clinical studies.
• Oversee and facilitate the eTMF access process. Ensure appropriate internal and external user permissions by monitoring, granting, modifying, and revoking access as needed.
• Serve as TMF Subject Matter Expert, supporting cross‑functional departments to ensure high quality documentation and appropriate TMF structure. Collaborate with internal and external stakeholders to resolve TMF quality issues.
• Monitor TMF health and provide study‑specific metrics according to the TMF Plan.
• Participate in the development and delivery of Veeva Clinical (eTMF) training for internal and external users.
• Support audit and inspection readiness activities, including TMF preparation.
• Identify and implement process improvements in collaboration with key stakeholders to aid with the improvement of TMF efficiency, usability, and compliance.
• Lead migrations of TMF content to Veeva Clinical (eTMF), if needed, working with Director, Clinical Compliance and Records to define resourcing and efforts required to complete TMF migrations.
• Ensure TMF content and metadata meet departmental standards, good documentation practices, and Good Clinical Practice (GCP) requirements.
• Serve as support for and back‑up to the Director of Clinical Compliance and Records, providing guidance and leadership for the TMF operations team and/or other clinical roles involved in TMF activities, ensuring alignment with departmental goals and organizational priorities.

Required Qualifications

• 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.
• Experience with the interpretation and application of ICH/GCP standards and FDA guidelines to varying phases of clinical studies.
• High level of competency with TMF Standard (i.e., TMF Reference Model), and working knowledge of Veeva Clinical and Veeva Quality workflows preferred.
• Proficiency with MS Office products Word, Excel, SharePoint, PowerPoint.
• Excellent interpersonal and professional skills and ability to work collaboratively across functional teams.
• Strong organizational and time management skills.
• Excellent communication skills, both oral and written.
• 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.

Preferred Requirements

• Prior experience supporting and/or participating in US FDA, EMA, MHRA or other health authority inspections
• Prior experience as a Business Administrator over electronic Trial Master File systems.

Work Location and Conditions

• This is a remote friendly role, but you must reside and work within the United States, and in a state where Amylyx currently does business, to be considered. Any change in your remote location must be approved by Amylyx.
• You will be required to follow Amylyx’s Remote Work Policy which includes:
  • Traveling to our corporate location in Cambridge, MA several times a year and attending other company‑related events as necessary and requested, which may include travel by air, driving, or public transportation.
  • Working in a setting that meets all requirements of the role (including privacy, reliable internet access, phone, ability to communicate via video conference, etc.) at your remote location.
  • Information security protocols and steps to maintain confidentiality of Amylyx information, technology, and materials.

Compensation

The pay range posted below represents our good faith estimate of compensation for this role, based on market data and internal benchmarks. The final offer may vary depending on a candidate’s experience, skills, and qualifications, as well as considerations of internal equity.

$171,000 – $192,000 USD

Equal Opportunity Employer

Amylyx Pharmaceuticals is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, pregnancy‑related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. 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. 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.