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) ManagementAccountable 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 evolveEstablishing 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.Supporting internal and external audits and inspections, may include but is not limited to: developing training materials and administering training to inspectors, managing inspector access, supporting teams with document retrieval during audit/inspection, providing system-related support, answering questions around the eTMF system and/or eTMF system procedures, and providing demos or guided-support for the eTMF system, as requested. Clinical/GCP Inspection ReadinessAs 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 the inspection readiness project deliverables, timelines, and resources.Organize inspection readiness meetings with the relevant study team members, the extended inspection team, and function-specific team IR meetingsContribute to the Development and implementation of tools and templates for the management of inspection readiness activities, including for example, 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, etc.)Supporting 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.Supporting study team members with the creation and management of storyboards, NTFs, and project-related documentation, as needed.Supporting gap assessments of clinical procedures and participating in the development and review of clinical SOPsSupport the clinical team on all inspection commitments, responses, post-inspection activities and the implementation of corrective and preventative actions.Working with quality and the inspection readiness lead in the development of Laminar onsite and remote inspection management procedures and logistics.Hiring, management, and/or oversight of resources including employees, contractors, consultants, vendorsLeading and conducting other projects/tasks as needed to support Larimar inspection readiness activities.Perform related duties as necessary or as assigned Requirements:
QualificationsMinimum 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 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 reportsHighly 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: Larimar Therapeutics offers all employees a competitive salary with frequent market benchmarking, incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.
We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner. We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.
Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs. The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory manner-without regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.
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