Associate Director / Director, Study Trial Master File

Description : Job Title :

Associate Director / Director, Study Trial Master File (TMF)

Location : Bala Cynwyd, PA

Travel :

Approximately 10% (domestic / international)

Reports to :

Chief Development Officer (initially)

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 Associate Director or Director to lead all aspects of Trial Master File (TMF) management for a single, global clinical trial. This TMF Owner will be fully accountable for the completeness, accuracy, quality, and regulatory compliance of the TMF for a global study, 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 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

TMF Oversight & Compliance

Serve as the TMF lead for a global clinical trial, fully accountable for the accuracy, consistency, completeness, and regulatory compliance of the Trial Master File from study start-up through final archival

Develop, update, and deliver TMF processes, procedures, and training in alignment with industry best practices and evolving regulatory requirements.

Lead the TMF plan and build study eTMF and ensure completeness accordingly

Ensure TMF documentation is consistent with specifications, internal SOPs, and applicable regulatory guidelines (ICH GCP, FDA, EMA, and other country-specific requirements).

Maintain TMF inspection- and submission-readiness throughout the trial lifecycle, monitoring quality and implementing corrective actions when necessary.

Act as the primary point of contact for all TMF-related activities, queries, and decisions for the trial.

Stay current with regulatory changes and industry best practices, translating them into actionable process improvements.

Process Management & Quality Control

Conduct ongoing quality control reviews of TMF content to ensure accuracy, timeliness, and compliance.

Establish and monitor TMF performance metrics, monitoring them, and proactively identifying and addressing documentation gaps. Report on metrics, highlighting risks, driving remediation, and presenting continuous improvement strategies to senior leadership.

Drive continuous improvement in TMF operations, including CAPAs and lessons learned.

Travel domestically and internationally ( 10%) for vendor oversight, study team meetings, audits, or inspections.

Cross-Functional Collaboration

Work closely with clinical operations, regulatory affairs, quality assurance, and other internal stakeholders to support timely and accurate documentation filing.

Lead TMF-related communications with study teams, ensuring alignment on responsibilities, timelines, and expectations.

Support inspection readiness activities, including internal reviews, mock inspections, and audit preparation.

Manage and build strong partnerships with external vendors, CROs, and internal stakeholders to ensure consistent TMF standards, timely document flow, and adherence to project milestones.

Manage third-party TMF vendor(s) involved in the trial, ensuring adherence to quality standards, timelines, and deliverables.

Serve as the business owner of the eTMF system for the study, including oversight of configuration, access controls, and change management.

Oversee records management for the trial, including off-site storage and archival, ensuring compliant chain-of-custody practices.

Inspection Readiness & Regulatory Support

Ensure the TMF is prepared for regulatory inspection at any point during the trial.

Lead TMF reviews and remediation efforts in preparation for audits or inspections.

Assist with audit response and CAPA development as needed.

Other responsibilities

Perform related duties as necessary or as assigned

Requirements : Qualifications

Minimum of 15+ years of relevant industry experience with a Bachelor's 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.

Strong, practical knowledge of the DIA 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.

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 :

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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