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:
Senior Manager/Associate Director, Technical Operations Supply Chain
Position Summary:
Reporting to the Director, Technical Operations, Head of Drug Product (DP) and Supply Chain, the Senior Manager/Associate Director, Technical Operations Supply Chain leads, plans, organizes, directs, and implements end-to-end clinical supply chain strategies to support the successful execution of clinical trials from study start-up to close-out at contract service providers (CSPs) on behalf of Larimar Therapeutics, Inc. This position works cross functionally within and across departments and business units to achieve objectives and is responsible for managing, supporting, and providing direction and leadership to project teams and functional leaders. In addition, the Technical Operations Senior Manager/Associate Director will take a hands-on approach to help functional leaders address critical supply strategies across the Larimar network.
Job Responsibilities:
The responsibilities may include but are not limited to the following activities:
- Develop and implement end-to-end clinical supply chain strategies to support the successful execution of clinical trials, from study start-up to close-out.
- Manage and optimize inventory levels of investigational drugs across multiple clinical trials, accounting for study requirements, patient enrollment projections, and site demand forecasts.
- Procurement and management of study drug, ancillary supplies, co-drugs/comparators, and medical devices/equipment.
- Work closely with internal and external stakeholders to optimize inventory ensuring adequate drug supply for ongoing and upcoming studies; including but not limited to Quality, Regulatory, and Clinical Operations.
- Partner with Clinical Operations and Quality on updates, or the future selection, development, and user acceptance of Interactive Response Technology (IRT) vendors for clinical trials.
- Oversee packaging, labeling, and distribution activities for investigational drugs, ensuring compliance with quality and regulatory requirements and industry standards.
- Establish strong relationships with contract service providers organizations (CSPs), packaging and labeling vendors, and third-party logistics providers to ensure reliable and cost-effective supply chain solutions.
- Monitor and mitigate supply chain risks, such as manufacturing delays, regulatory changes, and distribution challenges, to minimize impact on clinical trial timelines.
- Drive continuous improvement initiatives to enhance the efficiency, flexibility, and scalability of the clinical supply chain operation.
- Provide leadership and mentorship for clinical supply chain operations, fostering a culture of collaboration, innovation, and excellence.
- Serve as internal technical subject matter expert (SME) and point of contact (POC) with a focus on supporting clinical supply strategy.
- Ensure that project managers, quality stakeholders, and senior leaders are informed of issues at CSPs as they occur.
- Coordinate and ensures timely review of CSP documentation via internal document management systems and archival per current SOPs.
- Review and approve CSP documentation, authors internal protocols, reports, change controls, and regulatory filing as required; and ensures integrity of data produced to support regulatory filings.
- Data entry, data analysis and data trending.
- Ensures CSPs adhere to cGMP standards for all manufacturing processes.
- SME for audits/ inspections
- Collaborate with Quality, Clinical Operations, and other departments as applicable, on the development of new SOPs
- Maintains a good understanding of Regulatory and Quality aspects appropriate to all aspects of work.
Requirements:
Qualifications:
- Bachelor's degree in supply chain management, logistics, pharmacy, or related field; advanced degree (e.g., MBA, MS) preferred.
- Minimum of 8-10 of experience in clinical supply chain management within the pharmaceutical or biotechnology industry, with a proven track record of successfully managing complex clinical trials.
- Cold chain distribution experience required; ULT and refrigerated.
- Experience with building and maintaining IRT systems required.
- Experience with decentralized, direct-to-patient trials is required.
- Experience with implementation of ERP systems desired.
- In-depth knowledge of clinical trial drug supply management principles, GMP/GCP regulations, and industry best practices.
- Knowledge of IRT study drug assignment (randomization) and study drug inventory management.
- Strong analytical skills with the ability to interpret data, forecast demand, and optimize inventory levels effectively.
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and external partners.
- Proven leadership experience, with the ability to inspire and motivate team members to achieve departmental goals and objectives.
- Demonstrated ability to thrive in a fast-paced, dynamic environment and adapt to changing priorities and deadlines.
- Strong project management skills with the ability to manage multiple priorities simultaneously and drive projects to successful completion.
- Experience and expertise with global supply chain, including US, Europe, and UK; Import/Export, IOR, VAT, and reclamation.
- Demonstrated experience managing CSPs and CROs.
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.
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