Director, Trial Master File Management

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—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 with over 20 years of pharmaceutical industry experience each, and our workforce has significant expertise in discovery, non-clinical and clinical development, regulatory affairs, manufacturing, and CMC. Our 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.

About the role

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 work onsite at least two days a week in our Bala Cynwyd, PA corporate office.

Responsibilities

• 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 align 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.
• Manage the company’s eTMF system and support the implementation and integration of any systems or processes that interface with the eTMF (e.g., Regulatory Information Management (RIM), Quality Management System (QMS)), including data mapping between systems, configuring standard processes and workflows, and managing integrations on an ongoing basis.
• Establish governance structure and lead 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.
• Ensure 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.
• Create, manage, and execute/approve 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.
• Provide study support to cross-functional teams on TMF regulations, processes, and best practices, and support document management needs on studies including the development and review of study plans and documents.
• Support internal and external audits and inspections, including developing training materials, managing inspector access, supporting teams with document retrieval, providing system-related support, answering questions around the eTMF system, and providing demos or guided-support for the eTMF system.
• As a core member of the inspection readiness team, lead inspection readiness (IR) efforts across clinical study teams and work with cross-functional stakeholders to identify and ensure completion of inspection readiness activities and deliverables within associated project timelines.
• Contribute to inspection readiness project deliverables, timelines, and resources.
• Organize inspection readiness meetings with relevant study team members, the extended inspection team, and function-specific team IR meetings.
• Contribute to the development and implementation of tools and templates for the management of inspection readiness activities, including FDA BIMO checklists, project plans, timelines, training materials, study-specific tracking tools (e.g., issue management logs, study document and plan tracking, vendor lists, IT computer systems lists).
• Support study teams with the execution of IR tasks, as needed.
• Assist with identifying study issues and working with the clinical study team and Quality to develop CAPAs and strategies to mitigate risks.
• Support study team members with the creation and management of storyboards, NTFs, and project-related documentation.
• Support gap assessments of clinical procedures and participate in the development and review of clinical SOPs.
• Support the clinical team on all inspection commitments, responses, post-inspection activities, and the implementation of corrective and preventative actions.
• Work with Quality and the inspection readiness lead in the development of Larimar onsite and remote inspection management procedures and logistics.
• Hire, manage, and/or oversee resources including employees, contractors, consultants, and vendors.
• Lead and conduct other projects/tasks as needed to support Larimar inspection readiness activities.

Requirements

• Minimum of 15+ years of relevant industry experience with a Bachelor/MS degree, or 10+ years with a postgraduate degree.
• Experience managing TMF for global clinical trials including direct vendor oversight.
• Proven, hands-on experience with electronic TMF (eTMF) systems (e.g., Veeva Vault) and related clinical documentation platforms.
• Deep expertise in global regulatory requirements (e.g., ICH-GCP, FDA, EMA) and well-versed in industry best practices for Trial Master File (TMF) operations.
• Experience with health authority inspections at the Sponsor level in both front and backroom roles.
• Strong, practical knowledge of the CDISC TMF Reference Model and its application within operational settings.
• Broad understanding of end-to-end clinical trial operations and processes, with direct involvement in inspection readiness and compliance activities.
• Exceptional communication skills—able to clearly convey complex information to diverse stakeholders and foster collaboration across cross-functional teams.
• Experience managing direct reports.
• Highly skilled in project management, with the ability to oversee multiple concurrent initiatives, establish priorities, and consistently meet critical deadlines.
• Recognized for strategic problem-solving, organizational acumen, and meticulous attention to detail in a fast-paced environment.
• Ability and willingness to work onsite at least two days per week, while maintaining strong collaboration in a hybrid work model.

Benefits

• Competitive salary with frequent market benchmarking.
• Incentive stock options.
• Comprehensive benefits plan including 401K.
• Flexible PTO policy.