Larimar Therapeutics

Description: Larimar Therapeutics Inc. (Larimar) 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 (formerly referred to as 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 genetic abnormality. The company has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. If you are searching for a company where urgency, agility, and commitment to science win the day - we welcome you! Position Summary: Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director. Job Duties/Responsibilities: The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings Develop internal regulatory procedures and practices Work closely with RA Sr. Director and serve as backup to other global region regulatory activity Requirements: Key Experience, Skills and Knowledge: Minimum of 4-year undergraduate degree 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred Understanding of GxP systems and Quality principles Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications Excellent communication, time management and project management skills Continuous quality improvement mindset and attention to details Can do attitude, flexibility, and mental agility Equal Opportunity Employment 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 employment relationship with all 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. PI3b0ffc781f63-1144

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 (formerly referred to as 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. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position Summary: The Associate Director/Director of Commercial Supply Chain is responsible for the end-to-end design, launch readiness, and ongoing execution of the commercial supply chain supporting a recombinant fusion protein therapy for the treatment of Friedreich's ataxia. The product is a high-volume, daily subcutaneous therapy supplied as a lyophilized drug product requiring reconstitution with sterile water for injection. This leader ensures uninterrupted product availability, regulatory compliance, and operational excellence across manufacturing, packaging, distribution, and commercial fulfillment. The role partners closely with Drug Product Manufacturing, Clinical Supply Chain, Commercial (Marketing, Market Access, and Sales), Quality Assurance, Finance, and Medical Affairs to deliver a seamless patient experience that prevents missed doses and supports successful commercialization. The initial commercialization focus will be a United States launch, with concurrent strategic planning alongside commercial and distribution partners to enable phased ex-U.S. expansion. The Director will ensure global scalability of supply chain design, regulatory readiness, and distribution infrastructure to support future international market entry. Job Responsibilities: The responsibilities may include but are not limited to the following activities: Lead the development and execution of the commercial supply chain strategy supporting U.S. launch readiness and long-term lifecycle management while enabling scalable expansion into ex-U.S. markets. Translate demand forecasts into manufacturing, packaging, inventory, and distribution plans that ensure uninterrupted supply for a high-volume daily therapy. Oversee commercial readiness of drug product manufacturing, packaging, labeling, and distribution operations. Lead selection, qualification, and governance of CMOs, contract packaging organizations, and logistics partners. Provide expert oversight of shipping and transit validation programs, including temperature control, distribution lane qualification, and last-mile delivery. Establish and maintain product serialization and track-and-trace systems compliant with global regulatory requirements. Direct validation and lifecycle management of commercial packaging operations, including line qualification, process validation, and performance monitoring. Ensure effective vendor governance including approval of protocols, reports, quality documentation, and change controls. Partner with Quality Assurance to support deviations, investigations, CAPAs, and inspection readiness across the supply network. Coordinate cross-functional alignment with Drug Product Manufacturing, Clinical Supply Chain, Marketing, Market Access, Sales, Finance, Medical Affairs, and Quality. Lead inventory strategy, supply planning, and risk mitigation to prevent therapy interruption and missed patient doses. Implement operational metrics, dashboards, and continuous improvement initiatives across packaging, logistics, and distribution. Additional Functional Scope: The role is expected to provide leadership or deep expertise in the following areas: Cold chain and temperature-controlled logistics strategy Secondary packaging configuration and human-factors considerations for reconstitution Combination-product or administration-system integration (if applicable) Artwork management and labeling compliance Global trade compliance and import/export controls Demand planning, S&OP, and lifecycle inventory management Returns, complaints, and product disposition processes Cost-to-serve optimization and gross-to-net awareness Digital supply chain visibility and traceability systems Sustainability and waste-reduction initiatives in packaging and distribution Requirements: Qualifications: Education Bachelor's degree in Supply Chain, Engineering, Life Sciences, or related field required. Advanced degree (MBA, MS, or equivalent) preferred. Experience 10+ years of progressive experience in biopharmaceutical supply chain, with significant commercial-stage responsibility. Demonstrated leadership in launch readiness for sterile injectable or biologic therapies. Proven expertise in the following areas: Shipping and transit validation; Product serialization and track-and-trace compliance; Commercial packaging operations oversight and validation; Vendor governance across CMOs, CPOs, and logistics providers Experience supporting high-volume or chronic-use therapies strongly preferred. Prior responsibility for global distribution and specialty pharmacy channels desirable. Technical & Leadership Competencies Deep knowledge of cGMP, GDP, and regulatory expectations for biologics commercialization. Strong risk-management and problem-solving capabilities in complex supply environments. Financial acumen related to inventory, cost management, and commercial forecasting. Excellent cross-functional leadership, communication, and executive-presentation skills. Ability to operate effectively in a fast-paced, launch-driven environment with evolving priorities. PI1ed3c29914e4-5131

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 (formerly referred to as 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. The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices. The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects. We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Position: Director, Quality (GCP/GCLP/GVP) Reports to: Sr. Director, Quality Job Responsibilities: Position Overview: The Director, Quality (GCP/GCLP/GVP) will play a key role in shaping and strengthening Larimar's Quality Management System and advancing quality oversight across clinical product development and clinical studies. In this highly visible role, the candidate will collaborate cross-functionally to proactively manage GCP/GCLP/GVP regulatory risks, support inspection readiness, and continuously improve quality standards utilizing insights from inspections, audits, and evolving regulatory landscapes. This position will also assist with management of internal quality systems and processes while ensuring compliance with Larimar requirements and relevant global GCP, GCLP and GVP regulations and guidelines. The Director, Quality (GCP/GCLP/GVP) works with all members of the Quality team, including relevant internal contractors, to ensure quality compliance internally and among the company's contractors, CROs, service providers, etc. to enable development, regulatory approval, and commercialization of the company's products. This role reports to the Sr. Director, Quality. Key Responsibilities: Will include but are not limited to: Develops, implements, and executes the risk-based audit strategy for Clinical and Pharmacovigilance programs. Oversees/leads the execution and completion of external audits of GCP/GCLP/GVP vendors and clinical trial sites, including collaboration with the business sponsors to share audit findings. Leads internal GCP/GCLP/GVP audits. Collaborates with Quality representatives at Larimar's CROs and service providers to ensure the appropriate Quality Agreements have been developed and implemented in support of Larimar's clinical studies. Develops and monitors Larimar's Risk Management Program for clinical studies. Ensures reporting of potential or confirmed violations to regulatory authorities, as appropriate. Provides Good Clinical Practices (GCP) guidance and training to internal teams Manages evaluation of new GCP/GCLP/GVP related regulations and potential implications for Larimar. Supports the development and/or revision of Quality, Clinical, and Pharmacovigilance processes and procedures including SOPs and risk assessment tools ensuring consistency and compliance with relevant GCP, GCLP, CLIA, FDA, EMA, and other global regulatory requirements. Directly supports inspection readiness preparation (core team) and supports regulatory agency inspection(s). Assists in compiling information for regulatory submissions and conducting quality reviews and auditing of regulatory submissions, as requested. Supports quality system monitoring reviews. Supports other Quality activities, as required. Approximately 15-20% travel required Requirements: Qualifications: Bachelor's degree in life sciences with a minimum of 10+ years experience in a Quality role supporting Clinical Operations and/or Pharmacovigilance departments within a biotechnology or pharmaceutical environment Experience managing GCP/GCLP/GVP quality processes, including risk management activities Demonstrated experience managing GCP inspections, including preparation and response activities Minimum of 3 years experience performing GCP/GCLP/GVP audits or comparable GxP audit experience Expert knowledge of GxP systems, quality principles, and GCP/GCLP/GVP regulations (FDA, MHRA, EMA, etc.) and guidance documents (GCP/ICH) and ability to translate understanding to practice Demonstrated ability to initiate process improvements and take initiative is required Must possess a strong attention to detail while having the ability to work independently and collaboratively, as required, in a fast-paced environment Benefits: Larimar Therapeutics offers all employees 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. PI5023f8a7b5-

The Company: This publicly held clinical-stage biotechnology company is focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform. Their lead product candidate, nomlabofusp, 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. The company has between 60 and 70 employees and has assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience. The management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, commercialization, and the development of manufacturing processes utilizing good manufacturing practices (GMPs). The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how and expertise to the development of CTI-1601 and other future pipeline programs. They are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success. Job Overview The Director, Data Management is a key leader within the Biometrics function, responsible for defining and executing the company's clinical data strategy across programs. This is a high-impact, hands-on leadership role suited for a dynamic biotech environment, where building, scaling, and transforming data management capabilities is critical to success. This individual will lead end-to-end clinical data management activities, drive operational excellence, and ensure delivery of high-quality, inspection-ready data and documentation to support regulatory submissions, audits, and global health authority inspections. Key Responsibilities Lead and scale the Data Management function, establishing vision, strategy, and execution plans aligned with company goals Oversee all aspects of clinical data management from study start-up through database lock, reporting, and archiving, ensuring continuous inspection readiness across programs Drive cross-functional collaboration with Clinical Development, Biostatistics, Regulatory, Quality, and external partners (e.g., CROs, vendors) to ensure seamless study execution and audit/inspection preparedness Establish and maintain data management standards, processes, and infrastructure, including SOPs, work instructions, and best practices aligned with inspection readiness expectations Provide oversight of key deliverables, including data management plans, edit check specifications, data validation processes, and database design (eCRFs), ensuring completeness, traceability, and auditability Ensure data quality, integrity, and timeliness through effective data review, cleaning strategies, and metrics-driven oversight, with a focus on producing inspection-ready datasets Lead and support inspection readiness activities, including preparation of documentation, participation in audits and regulatory inspections, and management of findings, CAPAs, and responses Identify and implement process improvements, innovative technologies, and scalable solutions to enhance efficiency, quality, and inspection preparedness Serve as a strategic partner to senior leadership, contributing to clinical development plans, regulatory strategy, and inspection readiness planning Foster a culture of accountability, collaboration, continuous improvement, and inspection readiness mindset within the team and across functions Qualifications: Bachelor's or Master's degree (or equivalent experience) in a scientific or related field 10+ years of progressive experience in clinical data management within biotech/pharma, CROs, or a combination of both Demonstrated success supporting global clinical trials across multiple phases, including regulatory submissions, audits, and health authority inspections Direct experience leading or supporting inspection readiness activities, including audit preparation, documentation review, and CAPA management strongly preferred Experience building or transforming data management functions in a resource-constrained or fast-paced environment preferred Strong working knowledge of EDC systems, eCRF design, database development, data standards, and clinical data workflows Proven ability to lead vendors/CROs and manage complex timelines across multiple programs Deep understanding of GCP, ICH guidelines, and regulatory expectations for inspection readiness, data quality, and data integrity Strategic thinker with the ability to operate hands-on and adapt to evolving priorities Excellent communication and stakeholder management skills, with the ability to influence across functions and levels Benefits: Larimar Therapeutics offers all employees 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. PI7b7e9efa60eb-8842