Teams at Larimar Therapeutics, Inc.

Leads clinical quality assurance for global Phase I-IV studies at a biotechnology company. Responsibilities include quality risk management, audit programs, deviation and CAPA oversight, CRO and vendor quality management, process development, inspection readiness, quality metrics, and regulatory compliance across GCP and applicable global requirements. Partners cross-functionally with clinical operations, data management, biostatistics, medical affairs, TMF management, and external providers.

Provides strategic and operational leadership for global pharmacovigilance across clinical development, commercialization, and post-marketing surveillance. Oversees safety systems, signal detection, case reports, aggregate reporting, benefit-risk assessments, vendors, regulatory compliance, inspections, safety agreements, and risk mitigation. Partners cross-functionally with clinical, regulatory, medical, quality, and commercial teams while advising executive leadership and supporting regulatory submissions, advisory committees, due diligence, and strategic transactions.

The Director, Business Development will strategize and execute on partnerships while managing relationships, conducting market analysis, and providing strategic guidance to leadership.