Senior Manager, Clinical Quality

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.

Job Responsibilities:

Position Overview:

The Senior Manager, Clinical Quality serves as the study-level quality leader for the clinical quality assurance program for a clinical-stage biotechnology company focused on developing innovative therapies for patients with rare diseases through novel cell-penetrating peptide technology. This highly visible, cross-functional role partners with Clinical Operations, TMF Management, Biostatistics, Data Management, Medical Affairs, and external service providers to ensure the quality and integrity of clinical trial activities throughout the product development lifecycle.

The Senior Manager is responsible for providing proactive quality oversight of ongoing and planned clinical studies; leading GCP quality risk management activities; managing audit programs; managing deviations, investigations, and CAPAs; supporting inspection readiness; and maintaining fit-for-purpose quality systems that comply with applicable global regulations and guidelines, including ICH GCP, FDA, EMA, MHRA, Health Canada, and other applicable regulatory requirements.

Key Responsibilities:

Will include but are not limited to:

• Provide proactive quality oversight for Phase I-IV clinical studies conducted globally, including reviewing study protocols, ICFs, study plans and other clinical trial specific documents
• Partner with study teams to identify Critical-to-Quality (CtQ) factors and Key Quality Indicators (KQI) to develop risk assessments and maintain quality risk registers.
• Lead investigations related to deviations, protocol noncompliance, quality events, and potential serious breaches. 
• Facilitate root cause analysis and ensure timely development, implementation, and effectiveness verification of CAPAs. 
• Lead investigator site audits, vendor audits, internal process audits, and for-cause audits, as needed
• Evaluate audit findings, assess compliance risk, and ensure timely escalation of significant observations or audit trends
• Provide quality oversight for CROs, laboratories, technology vendors, and other GxP service providers by completing vendor quality risk assessments to support vendor qualification activities. 
• Performs quality reviews of deviations, investigations and CAPAs associated with CROs, laboratories, technology vendors and other vendors supporting clinical studies
• Lead development, revision, and implementation of quality and clinical processes and procedures
• Support continuous improvement projects that enhance efficiency, effectiveness, and scalability of quality processes.
• Support Health Authority inspections and sponsor audits by coordinating inspection response activities, documentation requests, and/or corrective action commitments. 
• Facilitate lessons-learned assessments following inspections and significant quality events.
• Collect and generate quality metrics and trend analyses to support management reviews
• Support other Quality activities, as required.
• Approximately 10-15% travel required.

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