Director, Trial Master File Management

Description:

The Company:

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Our lead product candidate, Nomlabofusp (CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia. Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

We have assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. Our management team, employees, and consultants have significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing and CMC.

Our company's strategy is to become a leader in the treatment of rare diseases by leveraging our cell-penetrating technology platform and applying our team's know-how to the development of Nomlabofusp and our pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position Summary

We are seeking an experienced and detail-oriented Director to lead all aspects of Trial Master File (TMF) management across all studies. This role will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF, ensuring it remains inspection-ready throughout the study lifecycle. This is a hands-on leadership role that requires deep expertise in TMF operations, global regulatory standards, and cross-functional collaboration.

The successful candidate will be a strong leader with excellent communication and collaboration skills, preferably with 10-15 years' experience in managing clinical TMFs across the US and EU, and significant vendor management and inspection experience. This role will require a minimum of 2 days a week of onsite presence (or more as business needs require) in our Bala Cynwyd, PA corporate office.

Job Responsibilities

Trial Master File (TMF) Management

• Accountable for the company's TMF processes and systems, serving as the business process owner and the system owner for the eTMF.
• Develop and implement global standards, standard operating procedures, and corresponding controlled documents that are in line with ICH-GCP and all relevant regulatory requirements (e.g., EMA, FDA, MHRA) and industry best practices (e.g., CDISC), including the maintenance and update of the TMF index as changes occur to Larimar and/or vendor SOPs.
• Develop and implement TMF strategy within Larimar and identify, hire, oversee resources and/or vendors supporting the TMF/eTMF and TMF-related initiatives.
• Management of the company's eTMF system and support the implementation and integration of any systems or processes that would interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS), etc.), including data mapping between systems, configuring standard processes and workflows across systems, and managing integrations on an ongoing basis as business needs evolve
• Establishing governance structure and leading governance meetings with vendors including those supporting clinical studies (e.g., clinical CRO, data management provider) and any vendors supporting the TMF/eTMF including technology providers.
• Responsible for ensuring that the eTMF system remains in a validated state, and complies with all computer systems validations (CSV) regulations including Annex 11/Part 11 and GAMP.
• Creating, managing, and executing/approving validation documentation related to eTMF change and release management including IT change control documentation, user acceptance testing (UAT)/performance qualification (PQ) testing documents such as plans and test scripts.
• Providing study support to cross-functional teams on TMF regulations, processes, and best practices, and supporting document management needs on studies including the development and review of study plans and documents.
• Supporti…