Director, Business Technology

About Us:

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!

Job Description - Director, Business Technology

Senior leadership role responsible for overseeing the implementation, validation, operation, maintenance, and decommissioning of GxP computerized systems across Larimar in support of clinical and commercial operations. This position will support GxP systems such as (but not limited to) the Veeva Platform, Veeva Clinical Suite (eTMF), Veeva RIM, and Veeva PromoMats to ensure compliance with FDA, EMA, and GAMP 5 standards and requirements.

Responsibilities:

• Lead cross-functional planning and delivery with IT, Quality, business stakeholders, and vendors to implement, integrate, and sustain GxP computerized system applications.
• Drive vendor and license management (e.g., renewals, licensing costs) and provide financial oversight, including budget tracking, forecasting, and annual planning support.
• Drive program management/timelines and ensure timely communication if expected timelines/impacts are affected.
• Ensure appropriate system configuration, oversight of audit trail and periodic reviews, oversight of system BCP/DR, and data archival/retrieval processes.
• Define GxP computerized system processes and procedures to ensure intended use, validation and maintenance of the validated state.
• Establish an internal governance team to define shared standards and decisions across applications/vaults such as master data, integrations, and enterprise reporting.
• Manage strategic vendor relationships for GxP computerized systems and ensure end-to-end support for applications, integrations, and business processes.
• Provide leadership for CSV/CSA using a risk-based approach, including a validation plan, protocols (IQ/OQ/PQ), risk assessments, and a traceability matrix.
• Act as SME for ALCOA++ compliant GxP computerized systems, including system security and role/access management.
• Drive change control, CAPA, and deviation investigations for GxP computerized systems.
• Lead audit readiness and support internal/external audits, including vendor assessments and supplier qualification activities.
• Other duties as assigned.

Requirements

• Bachelor's degree with 15 years of experience or Master's degree with 10 years of experience in computer science, life sciences, or related fields or equivalent combination of education and experience.
• 10+ years of experience in technology leadership or business partnership roles (system implementation and application support) within Biotech/Pharma and GxP IT/Quality environments.
• Experience with developing system roadmaps and implementation of systems appropriate for the current and future state of the company.
• IT-related certification or equivalent experience and project management experience preferred.
• Deep understanding of 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
• Experience with computerized systems validation/computer software assurance (CSV/CSA).
• Practical knowledge and application of cGxP requirements (industry experience/awareness).
• Excellent project management, problem-solving, and communication skills (verbal and written) are required. Able to convey complicated data in an easy-to-understand manner for users and leadership.
• Deep understanding of system development life cycle (SDLC) principles and industry best practices.
• Deep understanding of data integrity, ALCOA++, and electronic records/electronic signatures (ERES) requirements.
• Understanding of compliance with the General Data Protection Regulation (GDPR) through the implementation, management, and enforcement of data privacy/sharing agreements.
• Experience with audit readiness is required.
• A current certification as a Veeva Vault Platform Administrator is required.
• Understanding of Veeva's current AI development and deployment strategy.

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.