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Arcellx, Inc. (http://www.arcellx.com/) is a clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to advance humanity by developing cell therapies that are safer, more effective, and more broadly accessible.
Purpose:
This position is a hybrid role including management of Regulatory Operations and Trial Master Files (TMFs). As Manager of Regulatory Operations, this position will implement and coordinate all aspects of regulatory submission activities as needed to support the continued development, approval, and maintenance of Arcellx’s programs. As the TMF Manager, this position will provide the leadership, subject matter expertise, vendor oversight and clinical study team support required to ensure that the electronic TMF (eTMF) is managed in accordance with relevant ICH guidelines, GCP regulatory requirements and other regulations, as appropriate. This individual will be part of a small team and is expected interface and effectively communicate with cross-functional members of the Arcellx team.
Key Performance Objectives:
Regulatory Operations
- Serve as Regulatory Operations project manager, collaborating with Regulatory Affairs staff and contributing functional areas to assure adequate prioritization, scheduling, preparation and dispatch of regulatory submissions
- Ensure completion of high-quality regulatory submissions (including briefing documents, IND/CTA/BLA filings, and other marketing applications) following regulatory guidelines and internal processes within expected timelines
- Responsible for all aspects of publishing submissions and submission components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks associated with or in support of authoring (formatting, editing, reviewing), publishing, production (paper and electronic), and archiving (paper and electronic), as applicable.
- Manage the preparation of responses to regulatory authority queries
- Assist with the interpretative analyses of key regulatory guidance documents related to submissions.
- Develop and maintain regulatory deliverables schedule
- Organize and maintain regulatory documentation, including submissions and correspondence
- Contribute to a high performing regulatory team focused on accountability and meeting and exceeding expectations
Trial Master Files
- Oversee the strategy, management, and integration of an electronic TMF system, including vendors and technology
- Hands-on participation in the configuration and maintenance of the eTMF
- Provide training to study teams, including external partners and CRO staff, to ensure that TMF documents are processed in a timely manner and per SOP
- Create and maintain the eTMF Operating Model to include standards and best practices aligned across multiple programs and organizational goals
- Actively engage Clinical Coordinators, Study Managers, and external resources to ensure the receipt, processing and tracking of all clinical project-related documentation, including global study and site documents, in alignment with study TMF management plans
- Plan and manage periodic reviews of the study eTMF with metrics to assess the completeness and quality of the eTMF and effectively communicate status updates to the study team and department management
- Lead meetings to escalate trends, issues, and establish standards, while problem-solving and seeking appropriate endorsement across study teams and functions
- Work with external partners and study team to address gaps, issues and mitigate risks
- Oversee archive preparation of the submission-ready eTMF, liaising with CRO partners to ensure compliance with SOPs and project timelines
- Perform other duties as assigned
Desired Results:
- Establish and maintain an in-house Regulatory Operations system that meets expectations for
- Timeliness,
- Quality, and
- Completeness
- Key TMF management metrics include
- Completeness of TMF documents collected and approved
- Quality of documents collected and approved
- Timeliness of documentation collected and approved
Qualifications & Competencies: (Specific years of experience, skills, education level, traits, and values necessary to be successful in this role.)
- A minimum of a bachelor’s and/or other undergraduate degree is required
- A minimum of 5 years for Manager/10 years for Senior Manager of experience inclusive of postgraduate education and/or pharmaceutical or health care industry experience or equivalent is required
- A minimum of 7 years of experience of experience with processes and standards, regulatory technology (including publishing software), document management, and developing and managing electronic TMFs within the biotech/pharmaceutical industry is required
- Knowledge of ICH-GCP guidelines and FDA regulations and industry standards pertaining to regulatory operations and the management of TMF content is essential
- Experience directly supporting submission documents regarding clinical trials, marketing applications, and lifecycle management is highly preferred
- Extensive knowledge of clinical documents that are maintained in the eTMF is required
- Strong knowledge of electronic document and submissions standards and experience in eCTD publishing is required
- Prior BLA or NDA inspection readiness experience is highly desired
- Experience with regulations or product development in cell and gene therapy, such as CAR-Ts or CRISPR technology, is highly preferred
- Working knowledge of biology, chemistry and/or engineering relevant to pharmaceutical industry is preferred
- An understanding of health authority laws, regulations, guidance, and submission routes available for assigned products is preferred
Competencies
- Strong organizational skills
- Detail-oriented with excellent critical and logical thinking
- Must be flexible, with the ability and desire to multitask and function in a fast-paced entrepreneurial environment
- Strong initiative and drive – must be a self-starter who is able to anticipate departmental needs
- Works with a sense of urgency in performance of duties
- Interpersonal skills that promote a collaborative and productive environment
- Effective and efficient written and oral communication skills
- Knowledgeable in CTD/eCTD structure and requirements as well as submission requirements for all submission types in applicable region(s)
- Familiarity with the Trial Master File Reference model and a demonstrated understanding of records management best practices is required
- Advanced skills in MS Word, MS Excel, MS PowerPoint, and Adobe Acrobat are required
- Experienced with electronic publishing software and advanced PDF processing tools
- Experience with electronic document management software, principles of information systems, and related technology is required
- Submit cover letter and resume